Tumors
Conditions
Brief summary
The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.
Interventions
Atezolizumab will be given as IV infusion over 60 minutes on Day 1 of Cycle 1, then over 30 minutes (as tolerated) on Day 1 of each subsequent 3-week cycle.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically documented advanced solid tumors that meet protocol-defined cohort specifications, have progressive disease at study entry, and have received at least one line of prior systemic therapy or for which no alternative therapy to prolong survival exists * Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or in freshly cut and unstained slides (exceptional cases) with an associated pathology report for central testing * Measurable disease as defined by RECIST v1.1 or disease-specific criteria for prostate cancer and malignant pleural mesothelioma * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Negative serum pregnancy test result within 14 days prior to study drug among women of childbearing potential * Life expectancy \> 3 months
Exclusion criteria
* Malignancies other than disease under study within 5 years prior to Day 1 of Cycle 1 except those with a negligible risk of metastasis or death * Uncontrolled tumor-related pain * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures \>/=1 time per month * History of asymptomatic or symptomatic central nervous system (CNS) metastasis * Leptomeningeal disease * Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated but without evidence that disease has been clinically stable for \>/=2 weeks prior to Day 1 of Cycle 1 * Pregnant and lactating women * Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1 * Severe infection within 4 weeks prior to Day 1 of Cycle 1 * Oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1 * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation * History of autoimmune disease except treated/stable hypothyroidism, Type 1 diabetes mellitus, and protocol-specified dermatologic conditions * Active tuberculosis * Signs or symptoms of infection within 2 weeks prior to Day 1 of Cycle 1 * Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, or anti-programmed cell death-1 (PD-1) or anti-PD-L1 therapeutic antibodies * Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1, or anticipated requirement for systemic immunosuppressive medications during the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-progression Rate (NPR) at 18 Weeks | At Week 18 | NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA \<5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA \< 50% of the PSA reference value occurring at any time after treatment was initiated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) | ORR was defined as the percentage of participants with CR or PR as assessed by the investigator using RECIST v1.1 or Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA \<5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA \< 50% of the PSA reference value occurring at any time after treatment was initiated. |
| Percentage of Participants by Best Overall Response (BOR) | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) | BOR was based on RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria. For an individual participant BOR was obtained as follows: 1) CR: overall tumor response assessment of CR at 2 consecutive visits at least 28 days apart. 2) PR: overall tumor response assessment of PR or CR at 2 consecutive visits at least 28 days apart without being a CR. 3) SD: overall tumor response assessment of SD, PR, or CR at one or more visits at least 42 days after start of study treatment, but was not a confirmed CR or PR. 4) PD: an overall tumor response assessment of PD at any visit, and did not meet the criteria for a BOR of CR, PR or SD. 5) Missing: an assessment of SD, PR or CR in the first 42 days after start of study treatment and no further tumor assessments thereafter. |
| Clinical Benefit Rate (CBR) | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) | CBR was defined as the percentage of participants with CR, PR, or SD according to RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria lasting for \>/=6 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. For prostate cancer: CR: PSA \<5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA \< 50% of the PSA reference value occurring at any time after treatment was initiated. |
| Duration of Objective Response (DOR) | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) | DOR, based on RECIST v1.1, was defined as the time from the first occurrence of a documented objective response (CR or PR) to the time of progression or death from any cause, whichever occurred first. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. As pre-specified in the Statistical Analysis Plan (SAP) DOR was not analyzed if there were less than 4 participants available for the analysis. |
| Progression-Free Survival (PFS) | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) | PFS, based on RECIST v1.1, was defined as the time from the first day of study treatment to the first occurrence of disease progression or death from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. |
| Time to Progression (TTP) | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) | Time to progression (TTP), based on RECIST v1.1, was defined as time from the first day of study treatment to the first occurrence of progressive disease or death due to disease progression, whichever occurred first. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. |
| Overall Survival (OS) | Baseline until death due to any cause (up to 4.5 years) | OS was defined as the time from the first day of study treatment to death from any cause. |
| NPR at 24 Weeks | At Week 24 | NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA \<5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA \< 50% of the PSA reference value occurring at any time after treatment was initiated. |
| Treatment Duration of Atezolizumab | Baseline up to approximately 4.5 years | — |
| Mean Number of Doses of Atezolizumab | Baseline up to approximately 4.5 years | — |
| Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab | Baseline up to 4.5 years | — |
| Serum Concentration of Atezolizumab | Predose and postdose on Day 1 of Cycle 1, predose on Day 1 of Cycles 2, 3, 4, 8 (cycle length = 21 days), and every 8 cycles until treatment discontinuation; at follow up (approximately 120 days after last dose) up to approximately 4.5 years | — |
| Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) | Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/\>4 weeks from the date first documented. mBOR: 1) CR: overall tumor response assessment of CR at 2 consecutive visits at least 28 days apart. 2) PR: overall tumor response assessment of PR/CR at 2 consecutive visits at least 28 days apart without being a CR. 3) SD: overall tumor response assessment of SD/PR/CR at one or more visits at least 42 days after start of study treatment, but was not a confirmed CR or PR. 4) PD: an overall tumor response assessment of PD at any visit, and did not meet the criteria for a BOR of CR, PR or SD. 5) Missing: an assessment of SD, PR or CR in the first 42 days after start of study treatment and no further tumor assessments thereafter. |
| ORR Based on Modified RECIST v1.1 | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) | Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/\>4 weeks from the date first documented. ORR was defined as the percentage of participants with CR or PR. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. |
| CBR Based on Modified RECIST v1.1 | Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first) | Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/\>4 weeks from the date first documented. CBR was defined as the percentage of participants with CR, PR, or SD lasting for \>/=6 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. |
| Number of Participants With Adverse Events | Baseline up to 4.5 years | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event 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 adverse events. |
Countries
Austria, Brazil, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Russia, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at 47 sites in 18 countries: Austria, Brazil, Canada, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Russian Federation, Spain, Switzerland, Turkey, United Kingdom and United States.
Pre-assignment details
Participants with advanced solid tumors were eligible to enroll in the study.
Participants by arm
| Arm | Count |
|---|---|
| Atezolizumab Atezolizumab 1200 milligrams (mg) was administered by intravenous (IV) infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity. | 474 |
| Total | 474 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 309 |
| Overall Study | End of Cohort/End of Study | 67 |
| Overall Study | Lost to Follow-up | 31 |
| Overall Study | Other Reasons | 4 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 47 |
Baseline characteristics
| Characteristic | Atezolizumab |
|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 13.9 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 18 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 40 Participants |
| Race/Ethnicity, Customized Native Hawaiian Other Pacific Island | 4 Participants |
| Race/Ethnicity, Customized Not Available | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 383 Participants |
| Race/Ethnicity, Customized Not reported | 34 Participants |
| Race/Ethnicity, Customized Not Reported In France | 2 Participants |
| Race/Ethnicity, Customized Unknown | 17 Participants |
| Race/Ethnicity, Customized Unknown race | 37 Participants |
| Race/Ethnicity, Customized White | 406 Participants |
| Sex: Female, Male Female | 233 Participants |
| Sex: Female, Male Male | 241 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 310 / 474 |
| other Total, other adverse events | 368 / 474 |
| serious Total, serious adverse events | 142 / 474 |
Outcome results
Primary
Non-progression Rate (NPR) at 18 Weeks
NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA \<5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA \< 50% of the PSA reference value occurring at any time after treatment was initiated.
Time frame: At Week 18
Population: Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Overall Population | 26.8 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Cervical Cancer | 44.4 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Nasopharyngeal Carcinoma | 29.6 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | High Microsatellite Instability (MSI-H) or Mismatch Repair (MMR) Deficient Colorectal Cancer | 40.0 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Breast Cancer Type 1/2 Susceptibility Protein (BRCA) Mutated Ovarian Cancer | 26.7 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | BRCA Mutated Breast Cancer | 0 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Liposarcoma | 7.7 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Leiomyosarcoma | 17.6 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Gastrointestinal Stromal Tumor (GIST) | 20.0 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Undifferentiated Pleomorphic Sarcoma | 0 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Known Translocation-Related Sarcomas | 23.1 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Radiation Induced Sarcoma | 25.0 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Osteosarcoma | 45.5 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Chondrosarcoma | 16.7 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Pleural Mesothelioma | 38.5 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Peritoneal Mesothelioma | 42.9 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Cholangiocarcinoma/Cancer of the Biliary Tract | 15.4 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Anaplastic Thyroid Cancer (TC) | 6.7 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Follicular or Papillary Thyroid Cancer (TC) | 54.5 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Medullary/Follicular/Papillary TC | 28.6 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Gastric/Gastro-esophageal (GE) Junction Adenocarcinoma | 21.4 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Malignant Germ Cell Tumors | 7.1 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Estrogen Receptor (ER)+/Human EGF Receptor 2 (HER2)- Hypermutated Metastatic Breast Cancer (MBC) | 8.3 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Thymoma | 76.9 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Thymic cancer | 41.7 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Low/Intermediate Grade Carcinoid | 58.3 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Poorly Differentiated Grade (excluding small cell lung cancer [SCLC]) | 25.0 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Head and Neck Squamous Cell Carcinoma | 33.3 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Penile Cancer | 0 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Anal Cancer | 18.2 percentage of participants |
| Atezolizumab | Non-progression Rate (NPR) at 18 Weeks | Known MSI High or MMR Deficient Tumors | 40.0 percentage of participants |
Secondary
CBR Based on Modified RECIST v1.1
Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/\>4 weeks from the date first documented. CBR was defined as the percentage of participants with CR, PR, or SD lasting for \>/=6 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
Time frame: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
Population: Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Overall Population | 51.7 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Cervical Cancer | 59.3 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Nasopharyngeal Carcinoma | 63.0 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | MSI-H or MMR Deficient Colorectal Cancer | 60.0 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | BRCA Mutated Ovarian Cancer | 53.3 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | BRCA Mutated Breast Cancer | 25.0 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Liposarcoma | 38.5 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Leiomyosarcoma | 29.4 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Gastrointestinal Stromal Tumor (GIST) | 40.0 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Undifferentiated Pleomorphic Sarcoma | 9.1 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Known Translocation-Related Sarcomas | 53.8 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Radiation Induced Sarcoma | 50.0 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Osteosarcoma | 45.5 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Pleural Mesothelioma | 69.2 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Peritoneal Mesothelioma | 64.3 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Follicular or Papillary Thyroid Cancer (TC) | 81.8 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Gastric/GE Junction Adenocarcinoma | 42.9 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Malignant Germ Cell Tumors | 50.0 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | ER+/HER2- Hypermutated MBC | 33.3 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Thymoma | 84.6 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Thymic cancer | 58.3 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Low/Intermediate Grade Carcinoid | 100.0 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Poorly Differentiated Grade (excluding SCLC) | 33.3 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Head and Neck Squamous Cell Carcinoma | 50.0 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Penile Cancer | 50.0 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Chondrosarcoma | 50.0 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Cholangiocarcinoma/Cancer of the Biliary Tract | 69.2 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Anaplastic Thyroid Cancer (TC) | 13.3 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Medullary/Follicular/Papillary TC | 42.9 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Anal Cancer | 54.5 percentage of participants |
| Atezolizumab | CBR Based on Modified RECIST v1.1 | Known MSI High or MMR Deficient Tumors | 80.0 percentage of participants |
Secondary
Clinical Benefit Rate (CBR)
CBR was defined as the percentage of participants with CR, PR, or SD according to RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria lasting for \>/=6 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. For prostate cancer: CR: PSA \<5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA \< 50% of the PSA reference value occurring at any time after treatment was initiated.
Time frame: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
Population: Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atezolizumab | Clinical Benefit Rate (CBR) | Penile Cancer | 50.0 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Overall Population | 43.6 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Cervical Cancer | 55.6 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Nasopharyngeal Carcinoma | 51.9 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | MSI-H or MMR Deficient Colorectal Cancer | 40.0 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | BRCA Mutated Ovarian Cancer | 46.7 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | BRCA Mutated Breast Cancer | 8.3 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Liposarcoma | 30.8 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Leiomyosarcoma | 23.5 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Gastrointestinal Stromal Tumor (GIST) | 33.3 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Undifferentiated Pleomorphic Sarcoma | 9.1 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Known Translocation-Related Sarcomas | 42.3 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Radiation Induced Sarcoma | 25.0 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Osteosarcoma | 45.5 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Chondrosarcoma | 41.7 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Pleural Mesothelioma | 69.2 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Peritoneal Mesothelioma | 57.1 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Cholangiocarcinoma/Cancer of the Biliary Tract | 53.8 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Anaplastic Thyroid Cancer (TC) | 13.3 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Follicular or Papillary Thyroid Cancer (TC) | 81.8 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Medullary/Follicular/Papillary TC | 42.9 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Gastric/GE Junction Adenocarcinoma | 28.6 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Malignant Germ Cell Tumors | 35.7 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | ER+/HER2- Hypermutated MBC | 16.7 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Thymoma | 84.6 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Thymic cancer | 58.3 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Low/Intermediate Grade Carcinoid | 100.0 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Poorly Differentiated Grade (excluding SCLC) | 33.3 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Head and Neck Squamous Cell Carcinoma | 50.0 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Anal Cancer | 45.5 percentage of participants |
| Atezolizumab | Clinical Benefit Rate (CBR) | Known MSI High or MMR Deficient Tumors | 60.0 percentage of participants |
Secondary
Duration of Objective Response (DOR)
DOR, based on RECIST v1.1, was defined as the time from the first occurrence of a documented objective response (CR or PR) to the time of progression or death from any cause, whichever occurred first. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. As pre-specified in the Statistical Analysis Plan (SAP) DOR was not analyzed if there were less than 4 participants available for the analysis.
Time frame: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
Population: Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline. As pre-specified in the SAP DOR was not analyzed if there were less than 4 participants available for the analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Atezolizumab | Duration of Objective Response (DOR) | Thymoma | 19.0 months |
| Atezolizumab | Duration of Objective Response (DOR) | Cervical Cancer | 12.6 months |
| Atezolizumab | Duration of Objective Response (DOR) | Nasopharyngeal Carcinoma | NA months |
Secondary
Mean Number of Doses of Atezolizumab
Time frame: Baseline up to approximately 4.5 years
Population: Safety analysis set included all participants who received at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atezolizumab | Mean Number of Doses of Atezolizumab | 9.0 doses | Standard Deviation 11.28 |
Secondary
NPR at 24 Weeks
NPR was defined as the percentage of participants with complete response (CR), partial response (PR) or stable disease (SD) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 or for malignant pleural mesothelioma according to Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions in the absence of CR. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA \<5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA \< 50% of the PSA reference value occurring at any time after treatment was initiated.
Time frame: At Week 24
Population: Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atezolizumab | NPR at 24 Weeks | Anal Cancer | 18.2 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Overall Population | 22.4 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Cervical Cancer | 40.7 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Nasopharyngeal Carcinoma | 22.2 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | MSI-H or MMR Deficient Colorectal Cancer | 40.0 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | BRCA Mutated Ovarian Cancer | 20.0 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | BRCA Mutated Breast Cancer | 0 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Liposarcoma | 7.7 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Leiomyosarcoma | 11.8 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Gastrointestinal Stromal Tumor (GIST) | 13.3 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Undifferentiated Pleomorphic Sarcoma | 0 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Known Translocation-Related Sarcomas | 23.1 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Radiation Induced Sarcoma | 25.0 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Osteosarcoma | 45.5 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Chondrosarcoma | 0 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Pleural Mesothelioma | 23.1 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Peritoneal Mesothelioma | 28.6 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Cholangiocarcinoma/Cancer of the Biliary Tract | 7.7 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Anaplastic Thyroid Cancer (TC) | 6.7 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Follicular or Papillary Thyroid Cancer (TC) | 54.5 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Medullary/Follicular/Papillary TC | 28.6 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Gastric/GE Junction Adenocarcinoma | 7.1 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Malignant Germ Cell Tumors | 7.1 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | ER+/HER2- Hypermutated MBC | 8.3 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Thymoma | 76.9 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Thymic cancer | 33.3 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Low/Intermediate Grade Carcinoid | 58.3 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Poorly Differentiated Grade (excluding SCLC) | 16.7 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Head and Neck Squamous Cell Carcinoma | 16.7 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Penile Cancer | 0 percentage of participants |
| Atezolizumab | NPR at 24 Weeks | Known MSI High or MMR Deficient Tumors | 30.0 percentage of participants |
Secondary
Number of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event 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 adverse events.
Time frame: Baseline up to 4.5 years
Population: Safety analysis set included all participants who received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atezolizumab | Number of Participants With Adverse Events | 435 Participants |
Secondary
ORR Based on Modified RECIST v1.1
Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/\>4 weeks from the date first documented. ORR was defined as the percentage of participants with CR or PR. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Time frame: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
Population: Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Overall Population | 7.9 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Cervical Cancer | 14.8 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Nasopharyngeal Carcinoma | 11.1 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | MSI-H or MMR Deficient Colorectal Cancer | 0.0 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | BRCA Mutated Ovarian Cancer | 13.3 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | BRCA Mutated Breast Cancer | 0.0 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Osteosarcoma | 9.1 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Chondrosarcoma | 0.0 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Pleural Mesothelioma | 7.7 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Peritoneal Mesothelioma | 14.3 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Cholangiocarcinoma/Cancer of the Biliary Tract | 0.0 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Anaplastic Thyroid Cancer (TC) | 0.0 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Follicular or Papillary Thyroid Cancer (TC) | 9.1 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Medullary/Follicular/Papillary TC | 0.0 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Gastric/GE Junction Adenocarcinoma | 7.1 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Malignant Germ Cell Tumors | 0.0 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | ER+/HER2- Hypermutated MBC | 8.3 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Thymoma | 38.5 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Thymic cancer | 8.3 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Low/Intermediate Grade Carcinoid | 0.0 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Poorly Differentiated Grade (excluding SCLC) | 16.7 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Head and Neck Squamous Cell Carcinoma | 16.7 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Anal Cancer | 9.1 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Known MSI High or MMR Deficient Tumors | 20.0 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Liposarcoma | 0.0 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Leiomyosarcoma | 5.9 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Gastrointestinal Stromal Tumor (GIST) | 0.0 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Undifferentiated Pleomorphic Sarcoma | 0.0 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Known Translocation-Related Sarcomas | 7.7 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Radiation Induced Sarcoma | 12.5 percentage of participants |
| Atezolizumab | ORR Based on Modified RECIST v1.1 | Penile Cancer | 0.0 percentage of participants |
Secondary
Overall Response Rate (ORR)
ORR was defined as the percentage of participants with CR or PR as assessed by the investigator using RECIST v1.1 or Malignant Pleural Mesothelioma Response Evaluation Criteria. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. For prostate cancer according to Prostate Response Evaluation Criteria. CR: PSA \<5 ng/ml measured twice at least 3 weeks apart or PSA response: PSA \< 50% of the PSA reference value occurring at any time after treatment was initiated.
Time frame: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
Population: Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atezolizumab | Overall Response Rate (ORR) | Overall Population | 7.4 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Cervical Cancer | 14.8 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Nasopharyngeal Carcinoma | 7.4 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | MSI-H or MMR Deficient Colorectal Cancer | 0 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | BRCA Mutated Ovarian Cancer | 13.3 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | BRCA Mutated Breast Cancer | 0 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Liposarcoma | 0 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Leiomyosarcoma | 5.9 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Gastrointestinal Stromal Tumor (GIST) | 0 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Undifferentiated Pleomorphic Sarcoma | 0 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Known Translocation-Related Sarcomas | 7.7 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Radiation Induced Sarcoma | 12.5 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Osteosarcoma | 9.1 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Chondrosarcoma | 0 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Pleural Mesothelioma | 7.7 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Peritoneal Mesothelioma | 14.3 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Cholangiocarcinoma/Cancer of the Biliary Tract | 0 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Anaplastic Thyroid Cancer (TC) | 0 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Follicular or Papillary Thyroid Cancer (TC) | 9.1 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Medullary/Follicular/Papillary TC | 0 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Gastric/GE Junction Adenocarcinoma | 7.1 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Malignant Germ Cell Tumors | 0 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | ER+/HER2- Hypermutated MBC | 8.3 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Thymoma | 38.5 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Thymic cancer | 8.3 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Low/Intermediate Grade Carcinoid | 0 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Poorly Differentiated Grade (excluding SCLC) | 16.7 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Head and Neck Squamous Cell Carcinoma | 16.7 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Penile Cancer | 0 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Anal Cancer | 9.1 percentage of participants |
| Atezolizumab | Overall Response Rate (ORR) | Known MSI High or MMR Deficient Tumors | 20.0 percentage of participants |
Secondary
Overall Survival (OS)
OS was defined as the time from the first day of study treatment to death from any cause.
Time frame: Baseline until death due to any cause (up to 4.5 years)
Population: Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Atezolizumab | Overall Survival (OS) | Undifferentiated Pleomorphic Sarcoma | 5.59 months |
| Atezolizumab | Overall Survival (OS) | Known MSI High or MMR Deficient Tumors | 18.66 months |
| Atezolizumab | Overall Survival (OS) | Cervical Cancer | 14.78 months |
| Atezolizumab | Overall Survival (OS) | Nasopharyngeal Carcinoma | 17.97 months |
| Atezolizumab | Overall Survival (OS) | MSI-H or MMR Deficient Colorectal Cancer | 6.41 months |
| Atezolizumab | Overall Survival (OS) | BRCA Mutated Ovarian Cancer | 24.02 months |
| Atezolizumab | Overall Survival (OS) | BRCA Mutated Breast Cancer | 5.09 months |
| Atezolizumab | Overall Survival (OS) | Liposarcoma | 12.71 months |
| Atezolizumab | Overall Survival (OS) | Leiomyosarcoma | 9.66 months |
| Atezolizumab | Overall Survival (OS) | Gastrointestinal Stromal Tumor (GIST) | 7.39 months |
| Atezolizumab | Overall Survival (OS) | Known Translocation-Related Sarcomas | 17.74 months |
| Atezolizumab | Overall Survival (OS) | Radiation Induced Sarcoma | 8.33 months |
| Atezolizumab | Overall Survival (OS) | Osteosarcoma | 12.65 months |
| Atezolizumab | Overall Survival (OS) | Chondrosarcoma | 21.98 months |
| Atezolizumab | Overall Survival (OS) | Pleural Mesothelioma | 17.81 months |
| Atezolizumab | Overall Survival (OS) | Peritoneal Mesothelioma | 12.78 months |
| Atezolizumab | Overall Survival (OS) | Cholangiocarcinoma/Cancer of the Biliary Tract | 7.49 months |
| Atezolizumab | Overall Survival (OS) | Anaplastic Thyroid Cancer (TC) | 4.62 months |
| Atezolizumab | Overall Survival (OS) | Follicular or Papillary Thyroid Cancer (TC) | NA months |
| Atezolizumab | Overall Survival (OS) | Medullary/Follicular/Papillary TC | 18.92 months |
| Atezolizumab | Overall Survival (OS) | Gastric/GE Junction Adenocarcinoma | 8.57 months |
| Atezolizumab | Overall Survival (OS) | Malignant Germ Cell Tumors | 8.15 months |
| Atezolizumab | Overall Survival (OS) | ER+/HER2- Hypermutated MBC | 8.39 months |
| Atezolizumab | Overall Survival (OS) | Thymoma | NA months |
| Atezolizumab | Overall Survival (OS) | Thymic cancer | NA months |
| Atezolizumab | Overall Survival (OS) | Low/Intermediate Grade Carcinoid | 27.20 months |
| Atezolizumab | Overall Survival (OS) | Poorly Differentiated Grade (excluding SCLC) | 16.16 months |
| Atezolizumab | Overall Survival (OS) | Head and Neck Squamous Cell Carcinoma | 12.58 months |
| Atezolizumab | Overall Survival (OS) | Penile Cancer | 15.52 months |
| Atezolizumab | Overall Survival (OS) | Anal Cancer | NA months |
Secondary
Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR)
Modified RECIST was based on the following: 1) New measurable lesions were added into the total tumor burden and followed; 2) Non-target lesions contributed only in the assessment of a CR; 3) Radiographic progression was determined only on the basis of measurable disease; had to be confirmed by a consecutive assessment =/\>4 weeks from the date first documented. mBOR: 1) CR: overall tumor response assessment of CR at 2 consecutive visits at least 28 days apart. 2) PR: overall tumor response assessment of PR/CR at 2 consecutive visits at least 28 days apart without being a CR. 3) SD: overall tumor response assessment of SD/PR/CR at one or more visits at least 42 days after start of study treatment, but was not a confirmed CR or PR. 4) PD: an overall tumor response assessment of PD at any visit, and did not meet the criteria for a BOR of CR, PR or SD. 5) Missing: an assessment of SD, PR or CR in the first 42 days after start of study treatment and no further tumor assessments thereafter.
Time frame: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
Population: Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Gastric/GE Junction Adenocarcinoma: SD | 35.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Gastric/GE Junction Adenocarcinoma: PD | 35.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Gastric/GE Junction Adenocarcinoma: Missing | 21.4 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Malignant Germ Cell Tumors: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | ER+/HER2- Hypermutated MBC: PD | 58.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | ER+/HER2- Hypermutated MBC: Missing | 8.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Thymoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Thymoma: PR | 38.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Thymoma: SD | 46.2 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Thymoma: PD | 7.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Thymoma: Missing | 7.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Thymic cancer: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Thymic cancer: PR | 8.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Thymic cancer: SD | 50.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Thymic cancer: PD | 33.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Thymic cancer: Missing | 8.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Low/Intermediate Grade Carcinoid: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Low/Intermediate Grade Carcinoid: SD | 100.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Low/Intermediate Grade Carcinoid: PD | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Low/Intermediate Grade Carcinoid: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Poorly Differentiated Grade (excluding SCLC): PR | 16.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Poorly Differentiated Grade (excluding SCLC): SD | 16.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Poorly Differentiated Grade (excluding SCLC): PD | 58.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Penile Cancer: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Penile Cancer: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Penile Cancer: SD | 50.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Penile Cancer: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Anal Cancer: CR | 9.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Anal Cancer: SD | 45.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Anal Cancer: PD | 45.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Anal Cancer: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Known MSI High or MMR Deficient Tumors: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Known MSI High or MMR Deficient Tumors: SD | 60.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Known MSI High or MMR Deficient Tumors: PD | 20.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Known MSI High or MMR Deficient Tumors: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Anal Cancer: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Known MSI High or MMR Deficient Tumors: PR | 20.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Overall Population: CR | 0.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Overall Population: PR | 7.2 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Overall Population: SD | 43.9 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Overall Population: PD | 38.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Overall Population: Missing | 9.9 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Cervical Cancer: CR | 3.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Cervical Cancer: PR | 11.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Cervical Cancer: SD | 44.4 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Cervical Cancer: PD | 25.9 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Cervical Cancer: Missing | 14.8 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Nasopharyngeal Carcinoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Nasopharyngeal Carcinoma: PR | 11.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Nasopharyngeal Carcinoma: SD | 51.9 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Nasopharyngeal Carcinoma: PD | 33.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Nasopharyngeal Carcinoma: Missing | 3.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | MSI-H or MMR Deficient Colorectal Cancer: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | MSI-H or MMR Deficient Colorectal Cancer: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | MSI-H or MMR Deficient Colorectal Cancer: SD | 60.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | MSI-H or MMR Deficient Colorectal Cancer: PD | 30.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | MSI-H or MMR Deficient Colorectal Cancer: Missing | 10.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | BRCA Mutated Ovarian Cancer: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | BRCA Mutated Ovarian Cancer: PR | 13.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | BRCA Mutated Ovarian Cancer: SD | 40.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | BRCA Mutated Ovarian Cancer: PD | 33.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | BRCA Mutated Ovarian Cancer: Missing | 13.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | BRCA Mutated Breast Cancer: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | BRCA Mutated Breast Cancer: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | BRCA Mutated Breast Cancer: SD | 25.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | BRCA Mutated Breast Cancer: PD | 58.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | BRCA Mutated Breast Cancer: Missing | 16.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Liposarcoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Liposarcoma: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Liposarcoma: SD | 38.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Liposarcoma: PD | 53.8 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Liposarcoma: Missing | 7.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Leiomyosarcoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Leiomyosarcoma: PR | 5.9 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Leiomyosarcoma: SD | 23.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Leiomyosarcoma: PD | 47.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Leiomyosarcoma: Missing | 23.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Gastrointestinal Stromal Tumor (GIST): CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Gastrointestinal Stromal Tumor (GIST): PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Gastrointestinal Stromal Tumor (GIST): SD | 40.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Gastrointestinal Stromal Tumor (GIST): PD | 60.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Gastrointestinal Stromal Tumor (GIST): Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Undifferentiated Pleomorphic Sarcoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Undifferentiated Pleomorphic Sarcoma: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Undifferentiated Pleomorphic Sarcoma: SD | 9.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Undifferentiated Pleomorphic Sarcoma: PD | 81.8 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Undifferentiated Pleomorphic Sarcoma: Missing | 9.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Known Translocation-Related Sarcomas: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Known Translocation-Related Sarcomas: PR | 7.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Known Translocation-Related Sarcomas: SD | 46.2 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Known Translocation-Related Sarcomas: PD | 30.8 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Known Translocation-Related Sarcomas: Missing | 15.4 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Radiation Induced Sarcoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Radiation Induced Sarcoma: PR | 12.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Radiation Induced Sarcoma: SD | 37.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Radiation Induced Sarcoma: PD | 37.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Radiation Induced Sarcoma: Missing | 12.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Osteosarcoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Osteosarcoma: PR | 9.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Osteosarcoma: SD | 36.4 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Osteosarcoma: PD | 54.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Osteosarcoma: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Chondrosarcoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Chondrosarcoma: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Chondrosarcoma: SD | 50.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Chondrosarcoma: PD | 41.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Chondrosarcoma: Missing | 8.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Pleural Mesothelioma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Pleural Mesothelioma: PR | 7.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Pleural Mesothelioma: SD | 61.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Pleural Mesothelioma: PD | 23.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Pleural Mesothelioma: Missing | 7.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Peritoneal Mesothelioma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Peritoneal Mesothelioma: PR | 14.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Peritoneal Mesothelioma: SD | 50.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Peritoneal Mesothelioma: PD | 14.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Peritoneal Mesothelioma: Missing | 21.4 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Cholangiocarcinoma/Cancer of the Biliary Tract: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Cholangiocarcinoma/Cancer of the Biliary Tract: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Cholangiocarcinoma/Cancer of the Biliary Tract: SD | 69.2 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Cholangiocarcinoma/Cancer of the Biliary Tract: PD | 15.4 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Cholangiocarcinoma/Cancer of the Biliary Tract: Missing | 15.4 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Anaplastic Thyroid Cancer (TC): CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Anaplastic Thyroid Cancer (TC): PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Anaplastic Thyroid Cancer (TC): SD | 13.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Anaplastic Thyroid Cancer (TC): PD | 73.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Anaplastic Thyroid Cancer (TC): Missing | 13.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Follicular or Papillary Thyroid Cancer (TC): CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Follicular or Papillary Thyroid Cancer (TC): PR | 9.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Follicular or Papillary Thyroid Cancer (TC): SD | 72.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Follicular or Papillary Thyroid Cancer (TC): PD | 9.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Follicular or Papillary Thyroid Cancer (TC): Missing | 9.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Medullary/Follicular/Papillary TC: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Medullary/Follicular/Papillary TC: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Medullary/Follicular/Papillary TC: SD | 42.9 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Medullary/Follicular/Papillary TC: PD | 42.9 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Medullary/Follicular/Papillary TC: Missing | 14.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Gastric/GE Junction Adenocarcinoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Gastric/GE Junction Adenocarcinoma: PR | 7.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Malignant Germ Cell Tumors: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Malignant Germ Cell Tumors: SD | 50.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Malignant Germ Cell Tumors: PD | 50.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Malignant Germ Cell Tumors: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | ER+/HER2- Hypermutated MBC: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | ER+/HER2- Hypermutated MBC: PR | 8.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | ER+/HER2- Hypermutated MBC: SD | 25.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Low/Intermediate Grade Carcinoid: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Poorly Differentiated Grade (excluding SCLC): CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Poorly Differentiated Grade (excluding SCLC): Missing | 8.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Head and Neck Squamous Cell Carcinoma: CR | 16.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Head and Neck Squamous Cell Carcinoma: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Head and Neck Squamous Cell Carcinoma: SD | 33.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Head and Neck Squamous Cell Carcinoma: PD | 50.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Head and Neck Squamous Cell Carcinoma: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response Based on Modified RECIST v1.1 (mBOR) | Penile Cancer: PD | 50.0 percentage of participants |
Secondary
Percentage of Participants by Best Overall Response (BOR)
BOR was based on RECIST v1.1, Malignant Pleural Mesothelioma Response Evaluation Criteria or Prostate Response Evaluation Criteria. For an individual participant BOR was obtained as follows: 1) CR: overall tumor response assessment of CR at 2 consecutive visits at least 28 days apart. 2) PR: overall tumor response assessment of PR or CR at 2 consecutive visits at least 28 days apart without being a CR. 3) SD: overall tumor response assessment of SD, PR, or CR at one or more visits at least 42 days after start of study treatment, but was not a confirmed CR or PR. 4) PD: an overall tumor response assessment of PD at any visit, and did not meet the criteria for a BOR of CR, PR or SD. 5) Missing: an assessment of SD, PR or CR in the first 42 days after start of study treatment and no further tumor assessments thereafter.
Time frame: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
Population: Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Chondrosarcoma: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Malignant Germ Cell Tumors: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Peritoneal Mesothelioma: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Cholangiocarcinoma/Cancer of the Biliary Tract: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Osteosarcoma: PD | 54.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Overall Population: CR | 0.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Overall Population: PR | 6.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Overall Population: SD | 36.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Overall Population: PD | 53.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Overall Population: Missing | 3.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Cervical Cancer: CR | 3.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Cervical Cancer: PR | 11.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Cervical Cancer: SD | 40.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Cervical Cancer: PD | 40.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Cervical Cancer: Missing | 3.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Nasopharyngeal Carcinoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Nasopharyngeal Carcinoma: PR | 7.4 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Nasopharyngeal Carcinoma: SD | 44.4 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Nasopharyngeal Carcinoma: PD | 48.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Nasopharyngeal Carcinoma: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | MSI-H or MMR Deficient Colorectal Cancer: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | MSI-H or MMR Deficient Colorectal Cancer: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | MSI-H or MMR Deficient Colorectal Cancer: SD | 40.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | MSI-H or MMR Deficient Colorectal Cancer: PD | 50.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | MSI-H or MMR Deficient Colorectal Cancer: Missing | 10.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | BRCA Mutated Ovarian Cancer: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | BRCA Mutated Ovarian Cancer: PR | 13.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | BRCA Mutated Ovarian Cancer: SD | 33.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | BRCA Mutated Ovarian Cancer: PD | 46.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | BRCA Mutated Ovarian Cancer: Missing | 6.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | BRCA Mutated Breast Cancer: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | BRCA Mutated Breast Cancer: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | BRCA Mutated Breast Cancer: SD | 8.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | BRCA Mutated Breast Cancer: PD | 91.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | BRCA Mutated Breast Cancer: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Liposarcoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Liposarcoma: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Liposarcoma: SD | 30.8 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Liposarcoma: PD | 61.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Liposarcoma: Missing | 7.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Leiomyosarcoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Leiomyosarcoma: PR | 5.9 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Leiomyosarcoma: SD | 17.6 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Leiomyosarcoma: PD | 64.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Leiomyosarcoma: Missing | 11.8 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Gastrointestinal Stromal Tumor (GIST): CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Gastrointestinal Stromal Tumor (GIST): PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Gastrointestinal Stromal Tumor (GIST): SD | 33.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Gastrointestinal Stromal Tumor (GIST): PD | 66.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Gastrointestinal Stromal Tumor (GIST): Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Undifferentiated Pleomorphic Sarcoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Undifferentiated Pleomorphic Sarcoma: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Undifferentiated Pleomorphic Sarcoma: SD | 9.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Undifferentiated Pleomorphic Sarcoma: PD | 90.9 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Undifferentiated Pleomorphic Sarcoma: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Known Translocation-Related Sarcomas: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Known Translocation-Related Sarcomas: PR | 7.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Known Translocation-Related Sarcomas: SD | 34.6 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Known Translocation-Related Sarcomas: PD | 53.8 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Known Translocation-Related Sarcomas: Missing | 3.8 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Radiation Induced Sarcoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Radiation Induced Sarcoma: PR | 12.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Radiation Induced Sarcoma: SD | 12.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Radiation Induced Sarcoma: PD | 75.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Radiation Induced Sarcoma: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Osteosarcoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Osteosarcoma: PR | 9.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Osteosarcoma: SD | 36.4 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Osteosarcoma: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Chondrosarcoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Chondrosarcoma: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Chondrosarcoma: SD | 41.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Chondrosarcoma: PD | 58.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Pleural Mesothelioma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Pleural Mesothelioma: PR | 7.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Pleural Mesothelioma: SD | 61.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Pleural Mesothelioma: PD | 30.8 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Pleural Mesothelioma: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Peritoneal Mesothelioma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Peritoneal Mesothelioma: PR | 14.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Peritoneal Mesothelioma: SD | 42.9 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Peritoneal Mesothelioma: PD | 42.9 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Cholangiocarcinoma/Cancer of the Biliary Tract: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Cholangiocarcinoma/Cancer of the Biliary Tract: SD | 53.8 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Cholangiocarcinoma/Cancer of the Biliary Tract: PD | 46.2 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Cholangiocarcinoma/Cancer of the Biliary Tract: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Anaplastic Thyroid Cancer (TC): CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Anaplastic Thyroid Cancer (TC): PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Anaplastic Thyroid Cancer (TC): SD | 13.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Anaplastic Thyroid Cancer (TC): PD | 73.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Anaplastic Thyroid Cancer (TC): Missing | 13.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Follicular or Papillary Thyroid Cancer (TC): CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Follicular or Papillary Thyroid Cancer (TC): PR | 9.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Follicular or Papillary Thyroid Cancer (TC): SD | 72.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Follicular or Papillary Thyroid Cancer (TC): PD | 18.2 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Follicular or Papillary Thyroid Cancer (TC): Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Medullary/Follicular/Papillary TC: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Medullary/Follicular/Papillary TC: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Medullary/Follicular/Papillary TC: SD | 42.9 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Medullary/Follicular/Papillary TC: PD | 42.9 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Medullary/Follicular/Papillary TC: Missing | 14.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Gastric/GE Junction Adenocarcinoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Gastric/GE Junction Adenocarcinoma: PR | 7.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Gastric/GE Junction Adenocarcinoma: SD | 21.4 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Gastric/GE Junction Adenocarcinoma: PD | 57.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Gastric/GE Junction Adenocarcinoma: Missing | 14.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Malignant Germ Cell Tumors: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Malignant Germ Cell Tumors: SD | 35.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Malignant Germ Cell Tumors: PD | 64.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Malignant Germ Cell Tumors: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | ER+/HER2- Hypermutated MBC: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | ER+/HER2- Hypermutated MBC: PR | 8.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | ER+/HER2- Hypermutated MBC: SD | 8.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | ER+/HER2- Hypermutated MBC: PD | 83.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | ER+/HER2- Hypermutated MBC: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Thymoma: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Thymoma: PR | 38.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Thymoma: SD | 46.2 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Thymoma: PD | 7.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Thymoma: Missing | 7.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Thymic cancer: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Thymic cancer: PR | 8.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Thymic cancer: SD | 50.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Thymic cancer: PD | 41.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Thymic cancer: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Low/Intermediate Grade Carcinoid: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Low/Intermediate Grade Carcinoid: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Low/Intermediate Grade Carcinoid: SD | 100.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Low/Intermediate Grade Carcinoid: PD | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Low/Intermediate Grade Carcinoid: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Poorly Differentiated Grade (excluding SCLC): CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Poorly Differentiated Grade (excluding SCLC): PR | 16.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Poorly Differentiated Grade (excluding SCLC): SD | 16.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Poorly Differentiated Grade (excluding SCLC): PD | 66.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Poorly Differentiated Grade (excluding SCLC): Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Head and Neck Squamous Cell Carcinoma: CR | 16.7 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Head and Neck Squamous Cell Carcinoma: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Head and Neck Squamous Cell Carcinoma: SD | 33.3 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Head and Neck Squamous Cell Carcinoma: PD | 50.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Head and Neck Squamous Cell Carcinoma: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Penile Cancer: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Penile Cancer: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Penile Cancer: SD | 50.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Penile Cancer: PD | 50.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Penile Cancer: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Anal Cancer: CR | 9.1 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Anal Cancer: PR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Anal Cancer: SD | 36.4 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Anal Cancer: PD | 54.5 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Anal Cancer: Missing | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Known MSI High or MMR Deficient Tumors: CR | 0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Known MSI High or MMR Deficient Tumors: PR | 20.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Known MSI High or MMR Deficient Tumors: SD | 40.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Known MSI High or MMR Deficient Tumors: PD | 40.0 percentage of participants |
| Atezolizumab | Percentage of Participants by Best Overall Response (BOR) | Known MSI High or MMR Deficient Tumors: Missing | 0 percentage of participants |
Secondary
Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab
Time frame: Baseline up to 4.5 years
Population: Safety analysis set included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atezolizumab | Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab | Baseline ADAs | 1.9 percentage of participants |
| Atezolizumab | Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab | Treatment-emergent ADAs | 18.3 percentage of participants |
Secondary
Progression-Free Survival (PFS)
PFS, based on RECIST v1.1, was defined as the time from the first day of study treatment to the first occurrence of disease progression or death from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
Time frame: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
Population: Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Atezolizumab | Progression-Free Survival (PFS) | Liposarcoma | 1.51 months |
| Atezolizumab | Progression-Free Survival (PFS) | Cervical Cancer | 4.14 months |
| Atezolizumab | Progression-Free Survival (PFS) | Nasopharyngeal Carcinoma | 3.15 months |
| Atezolizumab | Progression-Free Survival (PFS) | MSI-H or MMR Deficient Colorectal Cancer | 1.51 months |
| Atezolizumab | Progression-Free Survival (PFS) | BRCA Mutated Ovarian Cancer | 2.73 months |
| Atezolizumab | Progression-Free Survival (PFS) | BRCA Mutated Breast Cancer | 1.38 months |
| Atezolizumab | Progression-Free Survival (PFS) | Leiomyosarcoma | 2.69 months |
| Atezolizumab | Progression-Free Survival (PFS) | Gastrointestinal Stromal Tumor (GIST) | 1.41 months |
| Atezolizumab | Progression-Free Survival (PFS) | Undifferentiated Pleomorphic Sarcoma | 1.31 months |
| Atezolizumab | Progression-Free Survival (PFS) | Known Translocation-Related Sarcomas | 2.73 months |
| Atezolizumab | Progression-Free Survival (PFS) | Radiation Induced Sarcoma | 1.43 months |
| Atezolizumab | Progression-Free Survival (PFS) | Osteosarcoma | 2.96 months |
| Atezolizumab | Progression-Free Survival (PFS) | Chondrosarcoma | 1.87 months |
| Atezolizumab | Progression-Free Survival (PFS) | Pleural Mesothelioma | 4.11 months |
| Atezolizumab | Progression-Free Survival (PFS) | Peritoneal Mesothelioma | 4.78 months |
| Atezolizumab | Progression-Free Survival (PFS) | Cholangiocarcinoma/Cancer of the Biliary Tract | 3.71 months |
| Atezolizumab | Progression-Free Survival (PFS) | Anaplastic Thyroid Cancer (TC) | 1.41 months |
| Atezolizumab | Progression-Free Survival (PFS) | Follicular or Papillary Thyroid Cancer (TC) | 8.48 months |
| Atezolizumab | Progression-Free Survival (PFS) | Medullary/Follicular/Papillary TC | 3.52 months |
| Atezolizumab | Progression-Free Survival (PFS) | Gastric/GE Junction Adenocarcinoma | 1.68 months |
| Atezolizumab | Progression-Free Survival (PFS) | Malignant Germ Cell Tumors | 2.73 months |
| Atezolizumab | Progression-Free Survival (PFS) | ER+/HER2- Hypermutated MBC | 1.22 months |
| Atezolizumab | Progression-Free Survival (PFS) | Thymoma | 11.76 months |
| Atezolizumab | Progression-Free Survival (PFS) | Thymic cancer | 4.07 months |
| Atezolizumab | Progression-Free Survival (PFS) | Low/Intermediate Grade Carcinoid | 8.54 months |
| Atezolizumab | Progression-Free Survival (PFS) | Poorly Differentiated Grade (excluding SCLC) | 1.40 months |
| Atezolizumab | Progression-Free Survival (PFS) | Head and Neck Squamous Cell Carcinoma | 2.76 months |
| Atezolizumab | Progression-Free Survival (PFS) | Penile Cancer | 2.07 months |
| Atezolizumab | Progression-Free Survival (PFS) | Anal Cancer | 3.12 months |
| Atezolizumab | Progression-Free Survival (PFS) | Known MSI High or MMR Deficient Tumors | 3.98 months |
Secondary
Serum Concentration of Atezolizumab
Time frame: Predose and postdose on Day 1 of Cycle 1, predose on Day 1 of Cycles 2, 3, 4, 8 (cycle length = 21 days), and every 8 cycles until treatment discontinuation; at follow up (approximately 120 days after last dose) up to approximately 4.5 years
Population: Safety analysis set included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atezolizumab | Serum Concentration of Atezolizumab | Cycle 24, Day 1 predose | 224556.7 ng/mL | Standard Deviation 104892.34 |
| Atezolizumab | Serum Concentration of Atezolizumab | Cycle 01, Day 1 predose | 45528.4 ng/mL | Standard Deviation 84303.42 |
| Atezolizumab | Serum Concentration of Atezolizumab | Cycle 01, Day 1 postdose | 422792.0 ng/mL | Standard Deviation 225600.85 |
| Atezolizumab | Serum Concentration of Atezolizumab | Cycle 02, Day 1 predose | 85674.3 ng/mL | Standard Deviation 35394.34 |
| Atezolizumab | Serum Concentration of Atezolizumab | Cycle 03, Day 1 predose | 131868.7 ng/mL | Standard Deviation 60596.06 |
| Atezolizumab | Serum Concentration of Atezolizumab | Cycle 04, Day 1 predose | 156555.7 ng/mL | Standard Deviation 67478.76 |
| Atezolizumab | Serum Concentration of Atezolizumab | Cycle 08, Day 1 predose | 201332.1 ng/mL | Standard Deviation 96547.07 |
| Atezolizumab | Serum Concentration of Atezolizumab | Cycle 16, Day 1 predose | 216038.7 ng/mL | Standard Deviation 97136.92 |
| Atezolizumab | Serum Concentration of Atezolizumab | Cycle 32, Day 1 predose | 253873.7 ng/mL | Standard Deviation 136820.7 |
| Atezolizumab | Serum Concentration of Atezolizumab | Cycle 40, Day 1 predose | 284000.0 ng/mL | Standard Deviation 110167.55 |
| Atezolizumab | Serum Concentration of Atezolizumab | Cycle 48, Day 1 predose | 319500.0 ng/mL | Standard Deviation 203543.61 |
| Atezolizumab | Serum Concentration of Atezolizumab | Cycle 56, Day 1 predose | 203000.0 ng/mL | — |
| Atezolizumab | Serum Concentration of Atezolizumab | Cycle 64, Day 1 predose | 217000.0 ng/mL | Standard Deviation 57982.76 |
| Atezolizumab | Serum Concentration of Atezolizumab | Follow Up | 17565.6 ng/mL | Standard Deviation 29505.18 |
Secondary
Time to Progression (TTP)
Time to progression (TTP), based on RECIST v1.1, was defined as time from the first day of study treatment to the first occurrence of progressive disease or death due to disease progression, whichever occurred first. PD: At least a 20% increase in the sum of diameters of all target and all new measurable lesions.
Time frame: Baseline up to 4.5 years (assessed every 6 weeks for first 24 weeks and thereafter every 12 weeks up to loss of clinical benefit, withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first)
Population: Efficacy analysis set included all eligible and evaluable participants. A participant was considered evaluable if they received study drug, had a baseline tumor assessment and at least one tumor assessment post-baseline.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Atezolizumab | Time to Progression (TTP) | Penile Cancer | 2.07 months |
| Atezolizumab | Time to Progression (TTP) | Cervical Cancer | 4.14 months |
| Atezolizumab | Time to Progression (TTP) | Nasopharyngeal Carcinoma | 3.45 months |
| Atezolizumab | Time to Progression (TTP) | MSI-H or MMR Deficient Colorectal Cancer | 1.51 months |
| Atezolizumab | Time to Progression (TTP) | BRCA Mutated Ovarian Cancer | 2.73 months |
| Atezolizumab | Time to Progression (TTP) | BRCA Mutated Breast Cancer | 1.38 months |
| Atezolizumab | Time to Progression (TTP) | Liposarcoma | 1.51 months |
| Atezolizumab | Time to Progression (TTP) | Leiomyosarcoma | 2.69 months |
| Atezolizumab | Time to Progression (TTP) | Gastrointestinal Stromal Tumor (GIST) | 1.41 months |
| Atezolizumab | Time to Progression (TTP) | Undifferentiated Pleomorphic Sarcoma | 1.31 months |
| Atezolizumab | Time to Progression (TTP) | Known Translocation-Related Sarcomas | 2.73 months |
| Atezolizumab | Time to Progression (TTP) | Radiation Induced Sarcoma | 1.43 months |
| Atezolizumab | Time to Progression (TTP) | Osteosarcoma | 2.96 months |
| Atezolizumab | Time to Progression (TTP) | Chondrosarcoma | 1.87 months |
| Atezolizumab | Time to Progression (TTP) | Pleural Mesothelioma | 4.11 months |
| Atezolizumab | Time to Progression (TTP) | Peritoneal Mesothelioma | 4.78 months |
| Atezolizumab | Time to Progression (TTP) | Cholangiocarcinoma/Cancer of the Biliary Tract | 3.71 months |
| Atezolizumab | Time to Progression (TTP) | Anaplastic Thyroid Cancer (TC) | 1.41 months |
| Atezolizumab | Time to Progression (TTP) | Follicular or Papillary Thyroid Cancer (TC) | 8.48 months |
| Atezolizumab | Time to Progression (TTP) | Medullary/Follicular/Papillary TC | 5.52 months |
| Atezolizumab | Time to Progression (TTP) | Gastric/GE Junction Adenocarcinoma | 1.68 months |
| Atezolizumab | Time to Progression (TTP) | Malignant Germ Cell Tumors | 2.73 months |
| Atezolizumab | Time to Progression (TTP) | ER+/HER2- Hypermutated MBC | 1.22 months |
| Atezolizumab | Time to Progression (TTP) | Thymoma | 12.58 months |
| Atezolizumab | Time to Progression (TTP) | Thymic cancer | 2.76 months |
| Atezolizumab | Time to Progression (TTP) | Low/Intermediate Grade Carcinoid | 8.54 months |
| Atezolizumab | Time to Progression (TTP) | Poorly Differentiated Grade (excluding SCLC) | 1.40 months |
| Atezolizumab | Time to Progression (TTP) | Head and Neck Squamous Cell Carcinoma | 2.76 months |
| Atezolizumab | Time to Progression (TTP) | Anal Cancer | 3.12 months |
| Atezolizumab | Time to Progression (TTP) | Known MSI High or MMR Deficient Tumors | 3.98 months |
Secondary
Treatment Duration of Atezolizumab
Time frame: Baseline up to approximately 4.5 years
Population: Safety analysis set included all participants who received at least one dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Atezolizumab | Treatment Duration of Atezolizumab | 2.513 months |