Non-Small Cell Lung Cancer
Conditions
Brief summary
This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.
Interventions
DRUGAtezolizumab
Atezolizumab will be administered as per the schedule specified in arm or cohort.
DRUGrHuPH20
rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intervention study model can be sequential or in parallel.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically documented locally advanced or metastatic NSCLC * Prior platinum-containing regimen or disease recurrence ≤ 6 months since prior platinum-based adjuvant/neoadjuvant regimen. * Measurable disease as defined by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy ≥12 weeks * Adequate hematologic and end-organ function Additional Inclusion Criteria (Part 2 Only) • Availability of tissue and known epidermal growth factor receptor (EGFR) status
Exclusion criteria
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Uncontrolled or symptomatic hypercalcemia * Pregnancy or breastfeeding * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis * Severe infection ≤ 4 weeks * Treatment with therapeutic oral or IV antibiotics ≤ 2 weeks prior to study treatment * Significant cardiovascular disease * Prior allogeneic stem cell or solid organ transplantation * Treatment with a live, attenuated vaccine ≤ 4 weeks * Treatment with systemic immunostimulatory agents ≤ 4 weeks or 5 half-lives of the drug * Treatment with systemic immunosuppressive medication ≤ 2 weeks Additional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1 | Pre-dose on Day 1 of Cycle 2 (Cycle length=21 days for cohorts 1 and 3 and 14 days for cohort 2) |
| Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1 | Predose on Day 1 of Cycle 2 (Cycle length =21 days) |
| Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1 | From start of dosing up to Day 21 in Cycle 1 (Cycle length = 21 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab | Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2) | — |
| Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab | Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2) | — |
| Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab | Predose and up to 21 days post dose in Cycle 1 for cohorts 1 and 3 and from predose up to 14 days post last dose in Cycle 1 for cohort 2 (Cycle length= 21 days for cohorts 1 and 3 and 14 days for cohort 2) | — |
| Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cohort 1: Predose: D1 & postdose: D1, 3, 8 of C1; Cohort 2: Pre & postdose: D1 of C1, 3 & postdose: D3, 8 of C1, Predose: D1 of C2; Cohort 3: Pre & postdose: D1 of C1, 2 & postdose: D3, 8 of C1, D2, 4 & 9 of C2 & pre dose: D1 of C3 | Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2. Day=D; Cycle=C. |
| Part 1: Percentage of Participants With Adverse Events (AEs) | From initiation of study treatment up to approximately 69 months | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 5.0 (NCI-CTCAE, v5.0). Percentages have been rounded to one decimal place. |
| Part 2: Percentage of Participants With AEs | From initiation of study treatment up to approximately 44.7 months | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, V5.0. Percentages have been rounded to one decimal place. |
| Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1 | Cycle 1 (Cycle length=21 days) | — |
| Part 2: Model Predicted Ctrough at Steady State (Ctrough,ss) of Atezolizumab | Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months) | 1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo. |
| Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab | Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months) | 1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo |
| Part 2: Objective Response Rate (ORR) | Up to approximately 25 months | ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \< 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD in the absence of CR. Percentage of participants who achieved confirmed objective response (CR or PR) have been reported. Percentages have been rounded to one decimal place. |
| Part 2: Progression-free Survival (PFS) | Up to approximately 25 months | PFS was defined as the time from study start to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. PFS was analyzed using the Kaplan-Meier method. |
| Part 2: Overall Survival (OS) | Up to approximately 44.7 months | OS was defined as the time from the date of study randomization to the date of death from any cause. |
| Part 2: Duration of Response (DOR) | Up to approximately 25 months | DOR was defined as the time from first occurrence of a documented confirmed objective response (CR or PR) to PD as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SODs must also demonstrate an absolute increase of ≥ 5 mm. |
| Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months) | EORTC IL57 questionnaire has 10 items and covers 3 scales: physical functioning (PF), role functioning (RF) & global health status/quality of life (GHS/QoL) & 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1=Not at all to 4=Very much) for physical and role functioning & a 7-point scale (where 1=Very poor to 7=Excellent) for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome. |
| Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months) | EORTC IL57 questionnaire has 10 items and covers 3 scales: PF, RF & GHS/QoL & 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1=Not at all to 4=Very much) for physical and role functioning & a 7-point scale (where 1=Very poor to 7=Excellent) for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome. |
| Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months) | EORTC IL57 questionnaire has 10 items and covers 3 scales: PF, RF & GHS/QoL & 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1=Not at all to 4=Very much) for physical and role functioning & a 7-point scale (where 1=Very poor to 7=Excellent) for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome. |
| Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ) | Day 1 Cycle 3 or Treatment Discontinuation Visit (if treatment discontinued at any visit before Cycle 3) (Cycle length = 21 days) | Modified SWT scale of the CTSQ consisted of seven items that measured seven domains related to satisfaction with cancer therapy. These include worthwhile, difficulty, benefits, feelings about side effects, form of therapy, overall satisfaction, and if participants would choose the therapy taking everything into consideration. Each domain is rated on a 5-point scale, with 1 representing the worst response and 5 representing the best response, except in the case of one reverse-scored item. Mean of the items were linearly transformed to obtain scores from 0-100, where 100 was the best possible score. Higher scores indicate higher satisfaction. Here, data for 'overall satisfaction' domain has been presented. |
| Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, and 64 (Cycle length = 21 days) | The overall patient-reported AE burden was assessed using a single item from the EORTC IL57 questionnaire i.e To what extent have you been troubled with side-effects from your treatment? The questions were answered on a 4-point Likert scale, where 1=Not at all to 4=Very much. Higher scores indicated greater AE burden. Percentages have been rounded to one decimal place. |
| Part 2: Percentage of Participants With Ant-Drug Antibodies (ADAs) to Atezolizumab After SC or IV Administration | From Cycle 1 Day 1 (Cycle length = 21 days) up to treatment discontinuation visit (Up to approximately 20 months) | The percentage of ADA-positive participants after atezolizumab administration was reported. Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded to one decimal place. |
| Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration | From Cycle 1 Day 1 (Cycle length = 21 days) up to treatment discontinuation visit (Up to approximately 20 months) | The percentage of ADA-positive participants after atezolizumab SC formulated with rHuPH20 administration was reported. Participants who received atezolizumab SC formulated with rHuPH20 were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following rHuPH20 exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded to one decimal place. |
| Part 2: Percentage of Health Care Professionals (HCPs) by Their Response to Question 2 of HCP SC Versus IV Perspective Questionnaire | After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months) | The HCP SC versus IV Perspective Questionnaire consisted of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 2 is being reported here: Question 2: Which formulation of atezolizumab (SC or IV) do you think is more convenient for you? Responses to this question are reported in the data table. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'first participant in \[FPI\]' date to 'last participant last visit \[LPLV\]' for Part 2). |
| Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Versus IV Perspective Questionnaire | After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months) | The HCP SC versus IV Perspective Questionnaire consisted of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 3 is being reported here: Question 3: If used in routine practice, do you think administering atezolizumab SC could save staff time compared to atezolizumab IV? The responses to this question could be Yes; No; Unsure. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). |
| Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Versus IV Perspective Questionnaire | After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months) | The HCP SC versus IV Perspective Questionnaire consisted of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 4 is being reported here: Question 4: Overall, were you more satisfied with atezolizumab SC or atezolizumab IV? The responses included: More satisfied with atezolizumab SC; Equally satisfied with both formulations; More satisfied with atezolizumab IV. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). |
| Part 2: Percentage of HCPs by Their Response to Question 2 of the HCP SC Perspective Questionnaire | After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months) | The HCP SC Perspective Questionnaire consisted of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 2 is being reported here: Question 2: Do you think atezolizumab SC is convenient? The responses to this question could be: Yes; No; and Unsure. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place. |
| Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Perspective Questionnaire | After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months) | The HCP SC Perspective Questionnaire consisted of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 3 is being reported here: Question 3: Overall, how easy did you find atezolizumab SC administration? The responses to this question could be: Very easy; Fairly easy; Not at all easy. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place. |
| Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Perspective Questionnaire | After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months) | The HCP SC Perspective Questionnaire consisted of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 4 is being reported here: Question 4: Overall, how satisfied were you with atezolizumab SC? The responses to this question could be: Very satisfied; Satisfied; Dissatisfied; Very dissatisfied. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place. |
Countries
Argentina, Brazil, Chile, China, Costa Rica, France, Greece, Guatemala, Hungary, Italy, Latvia, Mexico, New Zealand, Peru, Poland, Russia, South Africa, South Korea, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Participant flow
Recruitment details
A total of 438 participants with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) who were cancer immunotherapy (CIT)-naïve and for whom prior platinum-based therapy failed took part in the study across 23 countries from 27 December 2018 to 22 November 2024. The study is considered Completed because all the pre-planned study activities and analyses have been performed.
Pre-assignment details
Study consisted of 2 parts: Part 1 (Dose Finding) & Part 2 (Dose Confirmation). Health care professionals (HCPs) who administered the study treatment to participants were not enrolled in the study. To evaluate the HCPs' reported experience with administration of atezolizumab SC & atezolizumab IV, the HCPs were asked to complete two questionnaires: 'HCP SC Versus IV Perspective' & 'HCP SC Perspective'. No data other than the HCP's responses to these Questionnaires were collected in this study.
Participants by arm
| Arm | Count |
|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. | 13 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. | 15 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. | 39 |
| Part 2: Atezolizumab IV 1200 mg Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity. | 124 |
| Part 2: Atezolizumab SC 1875 mg Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity. | 247 |
| Total | 438 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 3 | 6 | 19 | 97 | 205 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 2 | 3 |
| Overall Study | New Therapy | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Study Ended by Sponsor | 1 | 0 | 1 | 17 | 28 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 6 | 8 | 11 |
Baseline characteristics
| Characteristic | Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 2: Atezolizumab IV 1200 mg | Part 2: Atezolizumab SC 1875 mg | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 8 Participants | 20 Participants | 66 Participants | 110 Participants | 209 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 7 Participants | 19 Participants | 58 Participants | 137 Participants | 229 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 5 Participants | 12 Participants | 36 Participants | 61 Participants | 115 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 9 Participants | 7 Participants | 25 Participants | 88 Participants | 185 Participants | 314 Participants |
| Race/Ethnicity, Customized Not Stated | 3 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 9 Participants | 15 Participants | 24 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 1 Participants | 33 Participants | 47 Participants | 85 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) White | 8 Participants | 11 Participants | 36 Participants | 74 Participants | 174 Participants | 303 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 12 Participants | 42 Participants | 72 Participants | 140 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 27 Participants | 82 Participants | 175 Participants | 298 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 13 | 6 / 15 | 19 / 39 | 97 / 124 | 206 / 247 |
| other Total, other adverse events | 13 / 13 | 12 / 15 | 31 / 39 | 91 / 124 | 204 / 247 |
| serious Total, serious adverse events | 2 / 13 | 4 / 15 | 8 / 39 | 35 / 124 | 50 / 247 |
Outcome results
Primary
Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1
Time frame: Pre-dose on Day 1 of Cycle 2 (Cycle length=21 days for cohorts 1 and 3 and 14 days for cohort 2)
Population: Pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1 | 121 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 42.8 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1 | 77.5 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 51.4 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1 | 78.3 micrograms per milliliter (μg/mL) | Geometric Coefficient of Variation 88.6 |
Primary
Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1
Time frame: From start of dosing up to Day 21 in Cycle 1 (Cycle length = 21 days)
Population: PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1 | 3327.9 micrograms day per mL (μg*day/mL) | Geometric Coefficient of Variation 19.4 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1 | 2907.1 micrograms day per mL (μg*day/mL) | Geometric Coefficient of Variation 35.9 |
90% CI: [0.83, 0.92]
Primary
Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1
Time frame: Predose on Day 1 of Cycle 2 (Cycle length =21 days)
Population: Per Protocol PK evaluable population included all participants randomized to the atezolizumab SC and atezolizumab IV treatment arms who did not have protocol deviations that could affect Cycle 1 observed Ctrough results.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1 | 85.4 μg/mL | Geometric Coefficient of Variation 34.1 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1 | 89.4 μg/mL | Geometric Coefficient of Variation 127.1 |
90% CI: [0.88, 1.24]
Secondary
Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab
Time frame: Predose and up to 21 days post dose in Cycle 1 for cohorts 1 and 3 and from predose up to 14 days post last dose in Cycle 1 for cohort 2 (Cycle length= 21 days for cohorts 1 and 3 and 14 days for cohort 2)
Population: PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab | 3870 μg*day/mL | Geometric Coefficient of Variation 38.6 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab | 1410 μg*day/mL | Geometric Coefficient of Variation 41.8 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab | 2820 μg*day/mL | Geometric Coefficient of Variation 38.6 |
Secondary
Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab
Time frame: Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2)
Population: PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab | 251 μg/mL | Geometric Coefficient of Variation 40.9 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab | 129 μg/mL | Geometric Coefficient of Variation 42.5 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab | 181 μg/mL | Geometric Coefficient of Variation 38.3 |
Secondary
Part 1: Percentage of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 5.0 (NCI-CTCAE, v5.0). Percentages have been rounded to one decimal place.
Time frame: From initiation of study treatment up to approximately 69 months
Population: Safety-evaluable population included all participants who received at least one dose of atezolizumab (IV or SC), with participants grouped according to treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 1: Percentage of Participants With Adverse Events (AEs) | 100 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 1: Percentage of Participants With Adverse Events (AEs) | 86.7 percentage of participants |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Percentage of Participants With Adverse Events (AEs) | 84.6 percentage of participants |
Secondary
Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration
Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2. Day=D; Cycle=C.
Time frame: Cohort 1: Predose: D1 & postdose: D1, 3, 8 of C1; Cohort 2: Pre & postdose: D1 of C1, 3 & postdose: D3, 8 of C1, Predose: D1 of C2; Cohort 3: Pre & postdose: D1 of C1, 2 & postdose: D3, 8 of C1, D2, 4 & 9 of C2 & pre dose: D1 of C3
Population: PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at a given timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 1, Day 1: Post-dose | 116 μg/mL | Geometric Coefficient of Variation 57.8 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 1, Day 1: Pre-dose | NA μg/mL | — |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 1, Day 3: Post-dose | 247 μg/mL | Geometric Coefficient of Variation 40.5 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 1, Day 8: Post-dose | 230 μg/mL | Geometric Coefficient of Variation 36.6 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 3, Day 1: Post-dose | 189 μg/mL | — |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 1, Day 1: Pre-dose | NA μg/mL | — |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 1, Day 1: Post-dose | 61.7 μg/mL | Geometric Coefficient of Variation 70.9 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 1, Day 3: Post-dose | 123 μg/mL | Geometric Coefficient of Variation 44.3 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 1, Day 8: Post-dose | 110 μg/mL | Geometric Coefficient of Variation 45 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 3, Day 1: Pre-dose | 104 μg/mL | Geometric Coefficient of Variation 47.8 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 2, Day 1: Pre-dose | 77.5 μg/mL | Geometric Coefficient of Variation 51.4 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 3, Day 1: Pre-dose | 123 μg/mL | Geometric Coefficient of Variation 57.2 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 1, Day 8: Post-dose | 162 μg/mL | Geometric Coefficient of Variation 43.5 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 2, Day 1: Pre-dose | 78.3 μg/mL | Geometric Coefficient of Variation 88.6 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 2, Day 1: Post-dose | 87.7 μg/mL | Geometric Coefficient of Variation 64.7 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 2, Day 2: Post-dose | 183 μg/mL | Geometric Coefficient of Variation 46.1 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 2, Day 4: Post-dose | 245 μg/mL | Geometric Coefficient of Variation 42 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 1, Day 1: Post-dose | 108 μg/mL | Geometric Coefficient of Variation 57.6 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 2, Day 9: Post-dose | 225 μg/mL | Geometric Coefficient of Variation 37.2 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 1, Day 3: Post-dose | 166 μg/mL | Geometric Coefficient of Variation 45.7 |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle 1, Day 1: Pre-dose | NA μg/mL | — |
Secondary
Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab
Time frame: Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2)
Population: PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab | 3.02 days |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab | 3.45 days |
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab | 3.92 days |
Secondary
Part 2: Change From Baseline in EORTC IL57 Global Health Status Score
EORTC IL57 questionnaire has 10 items and covers 3 scales: PF, RF & GHS/QoL & 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1=Not at all to 4=Very much) for physical and role functioning & a 7-point scale (where 1=Very poor to 7=Excellent) for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome.
Time frame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months)
Population: FAS included all randomized participants, with participants grouped according to their assigned treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 12 | 6.19 score on a scale | Standard Deviation 18.45 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 2 | -3.54 score on a scale | Standard Deviation 21.33 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 3 | -2.91 score on a scale | Standard Deviation 20.92 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 4 | -2.71 score on a scale | Standard Deviation 19.61 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 5 | 0.65 score on a scale | Standard Deviation 19.26 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 6 | -0.14 score on a scale | Standard Deviation 21.99 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 8 | 3.01 score on a scale | Standard Deviation 18.26 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 10 | 5.28 score on a scale | Standard Deviation 19.87 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Baseline | 66.52 score on a scale | Standard Deviation 17.68 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 14 | 7.50 score on a scale | Standard Deviation 17.42 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 16 | 6.55 score on a scale | Standard Deviation 17.77 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 18 | 4.71 score on a scale | Standard Deviation 19.11 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 20 | 9.52 score on a scale | Standard Deviation 16.73 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 22 | 5.56 score on a scale | Standard Deviation 21.2 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 24 | 7.29 score on a scale | Standard Deviation 28.2 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 26 | 1.56 score on a scale | Standard Deviation 24.95 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 28 | 1.79 score on a scale | Standard Deviation 16.72 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 30 | 5.77 score on a scale | Standard Deviation 16.45 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 32 | 0.00 score on a scale | Standard Deviation 18.46 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 34 | 0.00 score on a scale | Standard Deviation 20.07 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 36 | -1.52 score on a scale | Standard Deviation 15.73 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 38 | 2.27 score on a scale | Standard Deviation 21.11 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 40 | 5.30 score on a scale | Standard Deviation 21.5 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 42 | 0.00 score on a scale | Standard Deviation 17.25 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 44 | 2.08 score on a scale | Standard Deviation 18.23 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 46 | 2.08 score on a scale | Standard Deviation 25.88 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 48 | 7.14 score on a scale | Standard Deviation 15.54 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 50 | -2.38 score on a scale | Standard Deviation 17.16 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 52 | 8.33 score on a scale | Standard Deviation 12.91 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 54 | -2.78 score on a scale | Standard Deviation 12.73 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 56 | 4.17 score on a scale | Standard Deviation 5.89 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 58 | 0.00 score on a scale | — |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 60 | 8.33 score on a scale | — |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 62 | -8.33 score on a scale | — |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Treatment Discontinuation Visit | -14.53 score on a scale | Standard Deviation 26.28 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 30 | 3.17 score on a scale | Standard Deviation 21.81 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 58 | 0.00 score on a scale | Standard Deviation 0 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Baseline | 63.50 score on a scale | Standard Deviation 22 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 32 | 0.38 score on a scale | Standard Deviation 17.91 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 2 | -2.48 score on a scale | Standard Deviation 21.77 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 50 | 3.03 score on a scale | Standard Deviation 21.82 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 3 | -1.83 score on a scale | Standard Deviation 23.04 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 34 | 2.50 score on a scale | Standard Deviation 19.7 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 4 | -2.25 score on a scale | Standard Deviation 22.21 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 64 | 0.00 score on a scale | — |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 5 | -1.43 score on a scale | Standard Deviation 25.35 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 36 | 1.67 score on a scale | Standard Deviation 20.52 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 6 | 0.14 score on a scale | Standard Deviation 22.94 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 52 | -3.33 score on a scale | Standard Deviation 16.76 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 8 | 1.86 score on a scale | Standard Deviation 22.74 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 38 | 3.70 score on a scale | Standard Deviation 20.66 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 10 | 0.72 score on a scale | Standard Deviation 23.17 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 60 | 0.00 score on a scale | — |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 12 | -2.78 score on a scale | Standard Deviation 18.56 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 40 | 1.39 score on a scale | Standard Deviation 19.85 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 14 | 1.94 score on a scale | Standard Deviation 19.67 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 54 | 0.00 score on a scale | Standard Deviation 22.27 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 16 | 1.73 score on a scale | Standard Deviation 18.52 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 42 | 2.31 score on a scale | Standard Deviation 20.37 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 18 | 0.67 score on a scale | Standard Deviation 17.56 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Treatment Discontinuation Visit | -13.37 score on a scale | Standard Deviation 25.42 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 20 | -0.95 score on a scale | Standard Deviation 18.52 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 44 | 3.65 score on a scale | Standard Deviation 19.95 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 22 | 0.00 score on a scale | Standard Deviation 19.92 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 56 | 2.78 score on a scale | Standard Deviation 4.81 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 24 | -2.70 score on a scale | Standard Deviation 18.99 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 46 | 2.45 score on a scale | Standard Deviation 21.6 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 26 | -2.15 score on a scale | Standard Deviation 21.51 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 62 | 0.00 score on a scale | — |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 28 | 1.81 score on a scale | Standard Deviation 21.17 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | Change at Day 1 Cycle 48 | 4.17 score on a scale | Standard Deviation 20.35 |
Secondary
Part 2: Change From Baseline in EORTC IL57 Role Functioning Score
EORTC IL57 questionnaire has 10 items and covers 3 scales: PF, RF & GHS/QoL & 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1=Not at all to 4=Very much) for physical and role functioning & a 7-point scale (where 1=Very poor to 7=Excellent) for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome.
Time frame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months)
Population: FAS included all randomized participants, with participants grouped according to their assigned treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 8 | 4.96 score on a scale | Standard Deviation 29.47 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 18 | 0.72 score on a scale | Standard Deviation 21.6 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 20 | 7.94 score on a scale | Standard Deviation 30.1 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Baseline | 74.93 score on a scale | Standard Deviation 25.67 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 2 | 0.31 score on a scale | Standard Deviation 29.46 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 3 | -3.29 score on a scale | Standard Deviation 27.51 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 4 | -0.83 score on a scale | Standard Deviation 26.9 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 5 | 2.34 score on a scale | Standard Deviation 31.13 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 6 | 0.00 score on a scale | Standard Deviation 32.14 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 10 | 1.63 score on a scale | Standard Deviation 29.06 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 12 | 4.29 score on a scale | Standard Deviation 29.8 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 14 | 6.11 score on a scale | Standard Deviation 22.09 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 16 | -0.60 score on a scale | Standard Deviation 29.91 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 22 | 6.48 score on a scale | Standard Deviation 28.66 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 24 | 3.13 score on a scale | Standard Deviation 24.51 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 26 | 4.17 score on a scale | Standard Deviation 36.77 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 28 | 7.14 score on a scale | Standard Deviation 16.94 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 30 | -2.56 score on a scale | Standard Deviation 20.24 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 32 | -6.94 score on a scale | Standard Deviation 19.41 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 34 | -6.06 score on a scale | Standard Deviation 22.7 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 36 | -3.03 score on a scale | Standard Deviation 17.98 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 38 | 4.55 score on a scale | Standard Deviation 16.82 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 40 | 1.52 score on a scale | Standard Deviation 24.1 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 42 | -6.25 score on a scale | Standard Deviation 23.46 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 44 | -2.08 score on a scale | Standard Deviation 16.52 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 46 | 0.00 score on a scale | Standard Deviation 23.57 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 48 | 2.38 score on a scale | Standard Deviation 20.25 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 50 | 2.38 score on a scale | Standard Deviation 20.25 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 52 | 2.78 score on a scale | Standard Deviation 28.71 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 54 | -11.11 score on a scale | Standard Deviation 34.69 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 56 | 0.00 score on a scale | Standard Deviation 23.57 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 58 | -33.33 score on a scale | — |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 60 | 16.67 score on a scale | — |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 62 | 16.67 score on a scale | — |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Treatment Discontinuation Visit | -20.27 score on a scale | Standard Deviation 33.7 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 30 | 3.17 score on a scale | Standard Deviation 31.01 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 58 | 0.00 score on a scale | Standard Deviation 23.57 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 32 | -0.76 score on a scale | Standard Deviation 31.49 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 18 | -2.00 score on a scale | Standard Deviation 27.9 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 50 | 13.64 score on a scale | Standard Deviation 36.38 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 34 | 0.00 score on a scale | Standard Deviation 34.2 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Baseline | 74.86 score on a scale | Standard Deviation 27.51 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 64 | 16.67 score on a scale | — |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 2 | -4.36 score on a scale | Standard Deviation 24.48 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 36 | 1.67 score on a scale | Standard Deviation 31.48 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 3 | -4.67 score on a scale | Standard Deviation 25.83 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 52 | 1.67 score on a scale | Standard Deviation 24.15 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 4 | -6.59 score on a scale | Standard Deviation 28.63 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 38 | 5.56 score on a scale | Standard Deviation 26.2 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 5 | -5.22 score on a scale | Standard Deviation 30.27 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 60 | 16.67 score on a scale | — |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 6 | -5.74 score on a scale | Standard Deviation 29.39 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 16 | -1.26 score on a scale | Standard Deviation 27.12 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 8 | -1.95 score on a scale | Standard Deviation 25.5 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 40 | 1.85 score on a scale | Standard Deviation 28.52 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 10 | -0.82 score on a scale | Standard Deviation 24.71 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 54 | 2.08 score on a scale | Standard Deviation 36.12 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 12 | -2.66 score on a scale | Standard Deviation 30.2 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 42 | 3.70 score on a scale | Standard Deviation 32.11 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 14 | -3.61 score on a scale | Standard Deviation 30.24 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Treatment Discontinuation Visit | -21.14 score on a scale | Standard Deviation 34.8 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 20 | -2.65 score on a scale | Standard Deviation 27.83 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 44 | 7.29 score on a scale | Standard Deviation 31.6 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 22 | -5.09 score on a scale | Standard Deviation 34.23 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 56 | -5.56 score on a scale | Standard Deviation 19.25 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 24 | -4.41 score on a scale | Standard Deviation 29.39 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 46 | 4.90 score on a scale | Standard Deviation 32.68 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 26 | 0.54 score on a scale | Standard Deviation 27.38 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 62 | 16.67 score on a scale | — |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 28 | 5.07 score on a scale | Standard Deviation 29.91 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | Change at Day 1 Cycle 48 | 8.33 score on a scale | Standard Deviation 31.86 |
Secondary
Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score
EORTC IL57 questionnaire has 10 items and covers 3 scales: physical functioning (PF), role functioning (RF) & global health status/quality of life (GHS/QoL) & 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1=Not at all to 4=Very much) for physical and role functioning & a 7-point scale (where 1=Very poor to 7=Excellent) for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome.
Time frame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months)
Population: FAS included all randomized participants, with participants grouped according to their assigned treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 14 | 0.67 score on a scale | Standard Deviation 19.37 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 2 | -6.23 score on a scale | Standard Deviation 19.17 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 3 | -4.55 score on a scale | Standard Deviation 19.04 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 5 | -1.46 score on a scale | Standard Deviation 21.4 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 6 | -2.76 score on a scale | Standard Deviation 25.68 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 8 | -0.14 score on a scale | Standard Deviation 19.24 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 10 | -1.46 score on a scale | Standard Deviation 22.39 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 12 | 0.95 score on a scale | Standard Deviation 22.64 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Baseline | 74.53 score on a scale | Standard Deviation 20.37 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 16 | -2.14 score on a scale | Standard Deviation 23.38 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 18 | -0.87 score on a scale | Standard Deviation 19.1 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 20 | -1.59 score on a scale | Standard Deviation 22.3 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 22 | -2.22 score on a scale | Standard Deviation 23.54 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 24 | -0.83 score on a scale | Standard Deviation 22.69 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 26 | 0.83 score on a scale | Standard Deviation 17.36 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 28 | 2.38 score on a scale | Standard Deviation 14.7 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 30 | 2.05 score on a scale | Standard Deviation 16.42 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 32 | -6.67 score on a scale | Standard Deviation 21.27 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 34 | -2.42 score on a scale | Standard Deviation 16.4 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 36 | 0.61 score on a scale | Standard Deviation 17.24 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 38 | 3.64 score on a scale | Standard Deviation 17.22 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 40 | 0.00 score on a scale | Standard Deviation 25.65 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 42 | 1.67 score on a scale | Standard Deviation 19.76 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 44 | 5.83 score on a scale | Standard Deviation 12.57 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 46 | 5.83 score on a scale | Standard Deviation 16.88 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 48 | 8.57 score on a scale | Standard Deviation 10.69 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 50 | 4.76 score on a scale | Standard Deviation 14.76 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 52 | 12.22 score on a scale | Standard Deviation 12.94 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 54 | 11.11 score on a scale | Standard Deviation 10.18 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 56 | 10.00 score on a scale | Standard Deviation 4.71 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 58 | 6.67 score on a scale | — |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 60 | 20.00 score on a scale | — |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 62 | 13.33 score on a scale | — |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Treatment Discontinuation Visit | -19.01 score on a scale | Standard Deviation 28.26 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 4 | -5.75 score on a scale | Standard Deviation 22.04 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 32 | 0.61 score on a scale | Standard Deviation 22.34 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 60 | 13.33 score on a scale | — |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Baseline | 72.15 score on a scale | Standard Deviation 21.94 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 34 | 3.00 score on a scale | Standard Deviation 26.62 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 2 | -4.23 score on a scale | Standard Deviation 17.01 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 52 | 5.33 score on a scale | Standard Deviation 24.3 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 4 | -4.47 score on a scale | Standard Deviation 20.86 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 36 | 6.00 score on a scale | Standard Deviation 23.59 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 5 | -2.14 score on a scale | Standard Deviation 20.05 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Treatment Discontinuation Visit | -15.68 score on a scale | Standard Deviation 25.67 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 6 | -0.67 score on a scale | Standard Deviation 20.09 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 38 | 4.07 score on a scale | Standard Deviation 24.96 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 8 | -0.42 score on a scale | Standard Deviation 19.76 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 54 | 6.67 score on a scale | Standard Deviation 29.81 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 10 | 0.82 score on a scale | Standard Deviation 20.96 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 40 | 1.11 score on a scale | Standard Deviation 23.79 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 12 | 1.14 score on a scale | Standard Deviation 20.43 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 62 | 13.33 score on a scale | — |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 14 | 1.11 score on a scale | Standard Deviation 18.82 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 42 | 2.96 score on a scale | Standard Deviation 21.36 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 16 | 2.26 score on a scale | Standard Deviation 19.3 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 56 | 8.89 score on a scale | Standard Deviation 13.88 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 18 | 0.67 score on a scale | Standard Deviation 19.3 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 44 | 5.00 score on a scale | Standard Deviation 21.15 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 20 | -0.15 score on a scale | Standard Deviation 19.53 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 64 | 13.33 score on a scale | — |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 22 | -1.67 score on a scale | Standard Deviation 23.66 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 46 | 5.88 score on a scale | Standard Deviation 26.34 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 24 | -1.76 score on a scale | Standard Deviation 20.97 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 58 | 3.33 score on a scale | Standard Deviation 14.14 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 26 | -1.94 score on a scale | Standard Deviation 23.61 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 48 | 8.10 score on a scale | Standard Deviation 24.13 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 28 | 0.51 score on a scale | Standard Deviation 19.46 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 3 | -4.99 score on a scale | Standard Deviation 17.63 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 30 | 0.95 score on a scale | Standard Deviation 18.89 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | Change at Day 1 Cycle 50 | 9.09 score on a scale | Standard Deviation 29.25 |
Secondary
Part 2: Duration of Response (DOR)
DOR was defined as the time from first occurrence of a documented confirmed objective response (CR or PR) to PD as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SODs must also demonstrate an absolute increase of ≥ 5 mm.
Time frame: Up to approximately 25 months
Population: DOR-evaluable population included all participants with a measurable disease at baseline and a post-baseline confirmed objective response (CR or PR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Duration of Response (DOR) | 11.2 months |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Duration of Response (DOR) | 15.1 months |
p-value: 0.837595% CI: [0.34, 2.42]Log Rank
Secondary
Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab
1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo
Time frame: Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months)
Population: PK-evaluable population included all participants who received at least one dose of atezolizumab (atezolizumab SC or atezolizumab IV) and had at least 1 evaluable post dose PK sample. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab | 6107 ug*day/mL | Geometric Coefficient of Variation 27.3 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab | 6163 ug*day/mL | Geometric Coefficient of Variation 46.7 |
Secondary
Part 2: Model Predicted Ctrough at Steady State (Ctrough,ss) of Atezolizumab
1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo.
Time frame: Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months)
Population: PK-evaluable population included all participants who received at least one dose of atezolizumab (atezolizumab SC or atezolizumab IV) and had at least 1 evaluable post dose PK sample. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Model Predicted Ctrough at Steady State (Ctrough,ss) of Atezolizumab | 179 μg/mL | Geometric Coefficient of Variation 38.8 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Model Predicted Ctrough at Steady State (Ctrough,ss) of Atezolizumab | 205 μg/mL | Geometric Coefficient of Variation 58.1 |
Secondary
Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1
Time frame: Cycle 1 (Cycle length=21 days)
Population: PK evaluable population included all participants randomized to the atezolizumab SC and atezolizumab IV treatment arms with at least one post-baseline PK sample. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1 | 88.7 μg/mL | Geometric Coefficient of Variation 26.2 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1 | 97.2 μg/mL | Geometric Coefficient of Variation 42.3 |
Secondary
Part 2: Objective Response Rate (ORR)
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \< 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD in the absence of CR. Percentage of participants who achieved confirmed objective response (CR or PR) have been reported. Percentages have been rounded to one decimal place.
Time frame: Up to approximately 25 months
Population: Response-evaluable population included all participants with measurable disease at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Objective Response Rate (ORR) | 10.5 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Objective Response Rate (ORR) | 11.0 percentage of participants |
p-value: 0.875795% CI: [-6.56, 7.63]Cochran-Mantel-Haenszel
Secondary
Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ)
Modified SWT scale of the CTSQ consisted of seven items that measured seven domains related to satisfaction with cancer therapy. These include worthwhile, difficulty, benefits, feelings about side effects, form of therapy, overall satisfaction, and if participants would choose the therapy taking everything into consideration. Each domain is rated on a 5-point scale, with 1 representing the worst response and 5 representing the best response, except in the case of one reverse-scored item. Mean of the items were linearly transformed to obtain scores from 0-100, where 100 was the best possible score. Higher scores indicate higher satisfaction. Here, data for 'overall satisfaction' domain has been presented.
Time frame: Day 1 Cycle 3 or Treatment Discontinuation Visit (if treatment discontinued at any visit before Cycle 3) (Cycle length = 21 days)
Population: FAS included all randomized participants, with participants grouped according to their assigned treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ) | Day 1 Cycle 3 | 77.29 score on a scale | Standard Deviation 16.08 |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ) | Treatment Discontinuation Visit | 50.67 score on a scale | Standard Deviation 19.9 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ) | Day 1 Cycle 3 | 75.56 score on a scale | Standard Deviation 18.61 |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ) | Treatment Discontinuation Visit | 61.21 score on a scale | Standard Deviation 19.81 |
Secondary
Part 2: Overall Survival (OS)
OS was defined as the time from the date of study randomization to the date of death from any cause.
Time frame: Up to approximately 44.7 months
Population: FAS included all randomized participants, with participants grouped according to their assigned treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Overall Survival (OS) | 10.1 months |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Overall Survival (OS) | 10.9 months |
p-value: 0.976695% CI: [0.78, 1.27]Log Rank
Secondary
Part 2: Percentage of HCPs by Their Response to Question 2 of the HCP SC Perspective Questionnaire
The HCP SC Perspective Questionnaire consisted of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 2 is being reported here: Question 2: Do you think atezolizumab SC is convenient? The responses to this question could be: Yes; No; and Unsure. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place.
Time frame: After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months)
Population: Overall number analyzed included HCPs who completed Question 2 of the questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 2 of the HCP SC Perspective Questionnaire | Yes | 78.6 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 2 of the HCP SC Perspective Questionnaire | Unsure | 14.3 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 2 of the HCP SC Perspective Questionnaire | No | 7.1 percentage of HCPs |
Secondary
Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Perspective Questionnaire
The HCP SC Perspective Questionnaire consisted of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 3 is being reported here: Question 3: Overall, how easy did you find atezolizumab SC administration? The responses to this question could be: Very easy; Fairly easy; Not at all easy. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place.
Time frame: After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months)
Population: Overall number analyzed included HCPs who completed Question 3 of the questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Perspective Questionnaire | Very easy | 54.8 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Perspective Questionnaire | Fairly easy | 34.5 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Perspective Questionnaire | Not at all easy | 10.7 percentage of HCPs |
Secondary
Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Versus IV Perspective Questionnaire
The HCP SC versus IV Perspective Questionnaire consisted of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 3 is being reported here: Question 3: If used in routine practice, do you think administering atezolizumab SC could save staff time compared to atezolizumab IV? The responses to this question could be Yes; No; Unsure. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2).
Time frame: After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months)
Population: Overall number analyzed included HCPs who completed Question 3 of the questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Versus IV Perspective Questionnaire | Yes | 74.0 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Versus IV Perspective Questionnaire | Unsure | 14.0 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Versus IV Perspective Questionnaire | No | 12.0 percentage of HCPs |
Secondary
Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Perspective Questionnaire
The HCP SC Perspective Questionnaire consisted of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 4 is being reported here: Question 4: Overall, how satisfied were you with atezolizumab SC? The responses to this question could be: Very satisfied; Satisfied; Dissatisfied; Very dissatisfied. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place.
Time frame: After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months)
Population: Overall number analyzed included HCPs who completed Question 4 of the questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Perspective Questionnaire | Very satisfied | 34.5 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Perspective Questionnaire | Satisfied | 50.0 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Perspective Questionnaire | Dissatisfied | 13.1 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Perspective Questionnaire | Very dissatisfied | 2.4 percentage of HCPs |
Secondary
Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Versus IV Perspective Questionnaire
The HCP SC versus IV Perspective Questionnaire consisted of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 4 is being reported here: Question 4: Overall, were you more satisfied with atezolizumab SC or atezolizumab IV? The responses included: More satisfied with atezolizumab SC; Equally satisfied with both formulations; More satisfied with atezolizumab IV. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2).
Time frame: After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months)
Population: Overall number analyzed included HCPs who completed Question 4 of the questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Versus IV Perspective Questionnaire | More satisfied with atezolizumab SC | 32.0 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Versus IV Perspective Questionnaire | Equally satisfied with both formulations | 38.0 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Versus IV Perspective Questionnaire | More satisfied with atezolizumab IV | 30.0 percentage of HCPs |
Secondary
Part 2: Percentage of Health Care Professionals (HCPs) by Their Response to Question 2 of HCP SC Versus IV Perspective Questionnaire
The HCP SC versus IV Perspective Questionnaire consisted of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 2 is being reported here: Question 2: Which formulation of atezolizumab (SC or IV) do you think is more convenient for you? Responses to this question are reported in the data table. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'first participant in \[FPI\]' date to 'last participant last visit \[LPLV\]' for Part 2).
Time frame: After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months)
Population: Overall number analyzed included HCPs who completed Question 2 of the questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Health Care Professionals (HCPs) by Their Response to Question 2 of HCP SC Versus IV Perspective Questionnaire | Atezolizumab SC is much more convenient | 24.0 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Health Care Professionals (HCPs) by Their Response to Question 2 of HCP SC Versus IV Perspective Questionnaire | Atezolizumab SC is a little more convenient | 16.0 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Health Care Professionals (HCPs) by Their Response to Question 2 of HCP SC Versus IV Perspective Questionnaire | Both formulations are equally convenient | 26.0 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Health Care Professionals (HCPs) by Their Response to Question 2 of HCP SC Versus IV Perspective Questionnaire | Atezolizumab IV is a little more convenient | 12.0 percentage of HCPs |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Health Care Professionals (HCPs) by Their Response to Question 2 of HCP SC Versus IV Perspective Questionnaire | Atezolizumab IV is much more convenient | 22.0 percentage of HCPs |
Secondary
Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57
The overall patient-reported AE burden was assessed using a single item from the EORTC IL57 questionnaire i.e To what extent have you been troubled with side-effects from your treatment? The questions were answered on a 4-point Likert scale, where 1=Not at all to 4=Very much. Higher scores indicated greater AE burden. Percentages have been rounded to one decimal place.
Time frame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, and 64 (Cycle length = 21 days)
Population: FAS included all randomized participants, with participants grouped according to their assigned treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 40 - Quite a bit | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Baseline - A little | 36.3 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Baseline - Quite a bit | 8.0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Baseline - Very much | 6.2 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 2 - Not at all | 47.2 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 2 - A little | 39.8 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 2 - Quite a bit | 9.3 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 2 - Very much | 3.7 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 3 - Not at all | 43.2 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 3 - A little | 45.5 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 3 - Quite a bit | 10.2 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 3 - Very much | 1.1 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 4 - Not at all | 48.8 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 4 - A little | 36.6 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 4 - Quite a bit | 14.6 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 4 - Very much | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 5 - Not at all | 56.3 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 5 - A little | 35.9 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 5 - Quite a bit | 7.8 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 5 - Very much | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 6 - Not at all | 54.2 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 6 - A little | 37.3 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 6 - Quite a bit | 8.5 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 6 - Very much | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 8 - Not at all | 62.5 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 8 - A little | 33.3 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 8 - Quite a bit | 4.2 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 10 - Not at all | 66.7 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 10 - A little | 28.6 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 10 - Quite a bit | 4.8 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 12 - Not at all | 63.9 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 12 - A little | 30.6 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 12 - Quite a bit | 5.6 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 14 - Not at all | 61.3 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 14 - A little | 25.8 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 14 - Quite a bit | 12.9 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 16 - Not at all | 60.7 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 16 - A little | 28.6 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 16 - Quite a bit | 10.7 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 18 - Not at all | 69.6 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 18 - A little | 30.4 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 18 - Quite a bit | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 20 - Not at all | 71.4 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 20 - A little | 28.6 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 20 - Quite a bit | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 22 - Not at all | 55.6 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 22 - A little | 38.9 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 22 - Quite a bit | 5.6 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 24 - Not at all | 75.0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 24 - A little | 25.0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 24 - Quite a bit | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 26 - Not at all | 73.3 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 26 - A little | 26.7 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 26 - Quite a bit | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 28 - Not at all | 64.3 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 28 - A little | 35.7 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 28 - Quite a bit | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 30 - Not at all | 69.2 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 30 - A little | 30.8 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 30 - Quite a bit | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 32 - Not at all | 50.0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 32 - A little | 41.7 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 32 - Quite a bit | 8.3 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 34 - Not at all | 72.7 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 34 - A little | 27.3 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 36 - Not at all | 63.6 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 36 - A little | 36.4 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 38 - Not at all | 72.7 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 38 - A little | 27.3 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 38 - Quite a bit | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 40 - Not at all | 72.7 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 40 - A little | 27.3 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Baseline - Not at all | 49.6 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 42 - Not at all | 75.0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 42 - A little | 25.0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 44 - Not at all | 75.0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 44 - A little | 25.0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 46 - Not at all | 87.5 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 46 - A little | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 46 - Quite a bit | 12.5 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 48 - Not at all | 100 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 48 - A little | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 50 - Not at all | 100 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 50 - A little | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 52 - Not at all | 100 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 52 - A little | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 54 - Not at all | 100 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 54 - A little | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 56 - Not at all | 100 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 56 - A little | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 58 - Not at all | 100 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 58 - A little | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 60 - Not at all | 100 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 60 - A little | 0 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 62 - Not at all | 100 percentage of participants |
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 62 - A little | 0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 40 - Quite a bit | 5.6 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 24 - Not at all | 55.9 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Baseline - Not at all | 56.7 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 62 - A little | 100 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Baseline - A little | 28.6 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 24 - A little | 38.2 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Baseline - Quite a bit | 10.1 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 42 - Not at all | 66.7 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Baseline - Very much | 4.6 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 24 - Quite a bit | 5.9 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 2 - Not at all | 49.5 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 52 - A little | 40.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 2 - A little | 35.6 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 26 - Not at all | 51.6 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 2 - Quite a bit | 12.6 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 42 - A little | 33.3 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 2 - Very much | 2.3 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 26 - A little | 41.9 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 3 - Not at all | 46.7 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 58 - A little | 50.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 3 - A little | 41.8 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 26 - Quite a bit | 6.5 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 3 - Quite a bit | 8.7 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 44 - Not at all | 68.8 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 3 - Very much | 2.7 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 28 - Not at all | 56.5 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 4 - Not at all | 46.7 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 54 - Not at all | 50.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 4 - A little | 36.1 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 28 - A little | 39.1 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 4 - Quite a bit | 15.4 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 44 - A little | 31.3 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 4 - Very much | 1.8 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 28 - Quite a bit | 4.3 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 5 - Not at all | 55.9 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 62 - Not at all | 0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 5 - A little | 36.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 30 - Not at all | 70.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 5 - Quite a bit | 5.9 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 46 - Not at all | 76.5 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 5 - Very much | 2.2 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 30 - A little | 25.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 6 - Not at all | 49.2 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 54 - A little | 50.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 6 - A little | 40.2 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 30 - Quite a bit | 5.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 6 - Quite a bit | 8.2 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 46 - A little | 23.5 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 6 - Very much | 2.5 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 32 - Not at all | 59.1 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 8 - Not at all | 58.3 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 60 - Not at all | 0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 8 - A little | 37.5 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 32 - A little | 36.4 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 8 - Quite a bit | 4.2 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 46 - Quite a bit | 0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 10 - Not at all | 54.3 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 32 - Quite a bit | 4.5 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 10 - A little | 44.4 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 56 - Not at all | 0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 10 - Quite a bit | 1.2 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 34 - Not at all | 65.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 12 - Not at all | 50.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 48 - Not at all | 71.4 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 12 - A little | 45.7 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 34 - A little | 35.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 12 - Quite a bit | 4.3 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 64 - A little | 100 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 14 - Not at all | 53.3 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 36 - Not at all | 65.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 14 - A little | 45.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 48 - A little | 28.6 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 14 - Quite a bit | 1.7 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 36 - A little | 35.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 16 - Not at all | 56.6 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 56 - A little | 100 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 16 - A little | 35.8 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 38 - Not at all | 61.1 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 16 - Quite a bit | 7.5 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 50 - Not at all | 63.6 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 18 - Not at all | 58.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 38 - A little | 33.3 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 18 - A little | 36.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 60 - A little | 100 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 18 - Quite a bit | 6.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 38 - Quite a bit | 5.6 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 20 - Not at all | 59.1 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 50 - A little | 36.4 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 20 - A little | 31.8 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 40 - Not at all | 55.6 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 20 - Quite a bit | 9.1 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 58 - Not at all | 50.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 22 - Not at all | 52.8 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 40 - A little | 38.9 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 22 - A little | 36.1 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 52 - Not at all | 60.0 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | Day 1 Cycle 22 - Quite a bit | 11.1 percentage of participants |
Secondary
Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration
The percentage of ADA-positive participants after atezolizumab SC formulated with rHuPH20 administration was reported. Participants who received atezolizumab SC formulated with rHuPH20 were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following rHuPH20 exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded to one decimal place.
Time frame: From Cycle 1 Day 1 (Cycle length = 21 days) up to treatment discontinuation visit (Up to approximately 20 months)
Population: Safety-evaluable population included all participants who received at least one dose of atezolizumab SC formulated with rHuPH20. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration | 5.7 percentage of participants |
Secondary
Part 2: Percentage of Participants With AEs
An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, V5.0. Percentages have been rounded to one decimal place.
Time frame: From initiation of study treatment up to approximately 44.7 months
Population: Safety-evaluable population included all participants who received at least one dose of atezolizumab (IV or SC), with participants grouped according to treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants With AEs | 85.5 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants With AEs | 89.9 percentage of participants |
Secondary
Part 2: Percentage of Participants With Ant-Drug Antibodies (ADAs) to Atezolizumab After SC or IV Administration
The percentage of ADA-positive participants after atezolizumab administration was reported. Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded to one decimal place.
Time frame: From Cycle 1 Day 1 (Cycle length = 21 days) up to treatment discontinuation visit (Up to approximately 20 months)
Population: Safety-evaluable population included all participants who received at least one dose of atezolizumab (IV or SC), with participants grouped according to treatment received. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Percentage of Participants With Ant-Drug Antibodies (ADAs) to Atezolizumab After SC or IV Administration | 14.3 percentage of participants |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Percentage of Participants With Ant-Drug Antibodies (ADAs) to Atezolizumab After SC or IV Administration | 20.6 percentage of participants |
Secondary
Part 2: Progression-free Survival (PFS)
PFS was defined as the time from study start to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. PFS was analyzed using the Kaplan-Meier method.
Time frame: Up to approximately 25 months
Population: FAS included all randomized participants, with participants grouped according to their assigned treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Part 2: Progression-free Survival (PFS) | 2.9 months |
| Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Part 2: Progression-free Survival (PFS) | 2.8 months |
p-value: 0.690695% CI: [0.83, 1.33]Log Rank