Non-Small Cell Lung Cancer
Conditions
Brief summary
This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.
Interventions
DRUGBevacizumab-Pfizer
Bevacizumab-Pfizer: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles, followed by the assigned blinded bevacizumab monotherapy.
DRUGBevacizumab-EU
bevacizumab-EU: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles followed by the assigned blinded bevacizumab monotherapy.
DRUGPaclitaxel
Paclitaxel 200 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.
DRUGCarboplatin
carboplatin AUC =6.0 via IV infusions on Day 1 of a 21-day cyclefor each of at least 4 and no more than six (6) 21-day cycles.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients age at least 18 years of age, or age of consent in the region. * Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC). * Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC. * Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC.
Exclusion criteria
* Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature. * Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed. * Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK translocation positive mutations. * Prior systemic therapy for NSCLC; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) by Week 19 | 25 weeks | ORR refers to percentage of participants who achieved complete response (CR) or partial response (PR) by Week 19 of the study in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 which was subsequently confirmed by Week 25. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 55 weeks | Laboratory evaluation included hematology (hemoglobin, white blood cells, platelets and absolute neutrophil count), blood chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, serum or plasma creatinine, sodium, potassium, total calcium, magnesium, blood urea nitrogen or urea, and albumin ), coagulation (international normalized ratio for prothrombin time and activated partial thromboplastin time) and urinalysis (dipstick followed by a quantitative urine protein analysis for results of 2+ or greater). |
| Duration of Response (DOR) | 55 weeks | DOR was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. DOR was based on the Brookmeyer and Crowley method. |
| Progression Free Survival Rate at 55 Weeks | 55 weeks | This outcome measure refers to the possibility of being progression free at 55 weeks since start of study treatment, estimated from the Kaplan-Meier curve using the product-limit method. |
| Number of Participants With Treatment-Emergent Adverse Events | 55 weeks | AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
| Serum Concentration of Bevacizumab up to 1 Year | Pre-dose from Cycle 1 to Cycle 17, 2.5 hours post-dose in Cycle 1, and 1.5 hours post-dose in Cycle 5 | — |
| Number of Participants With Anti-Drug Antibody (ADA) | 55 weeks | ADA assay was performed using a sensitive, specific, and semi-quantitative electrochemiluminescent (ECL) method, which used biotinylated- and ruthenium-labeled PF-06439535 as reagents. Samples with ADA titer greater than or equal to (\>=) 2.29 were considered positive. |
| Number of Participants With Neutralizing Antibody (NAb) | 55 weeks | Only samples that were confirmed positive for ADA were further tested for NAb. The NAb analysis was conducted using a single validated quasi-quantitative enzyme-linked immunosorbent assay (ELISA) that utilized PF-06439535 as a reagent. Samples with NAb titer \>=1.70 were considered positive. |
| Survival Rate at 55 Weeks | 55 weeks | This outcome measure refers to the possibility of being alive at 55 weeks since start of study treatment, estimated from the Kaplan-Meier curve using the product-limit method. |
Countries
Australia, Brazil, Bulgaria, Chile, Croatia, Czechia, France, Germany, Greece, Hungary, India, Italy, Japan, Malaysia, Netherlands, Philippines, Poland, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United States
Participant flow
Pre-assignment details
A total of 719 participants were enrolled in this study, and 5 of them did not receive any therapy. One (1) additional participant received only chemotherapy, and did not receive blinded bevacizumab.
Participants by arm
| Arm | Count |
|---|---|
| PF-06439535 Participants received up to a maximum of 6 cycles of PF-06439535 (initial dose was 15 mg/kg) plus paclitaxel (initial dose was 200 mg/m\*2) and carboplatin (initial dose was AUC 6, based on participant's pre-existing renal function and desired platelet nadir), followed by PF-06439535 monotherapy until disease progression, unacceptable toxicity, discretion of the investigator, regulatory request, death, withdrawal of consent occurred. All 3 drugs were given by intravenous (IV) infusion on Day 1 in each 21-day cycle and dose reduction was allowed for paclitaxel and carboplatin in response to toxicity. Paclitaxel was administered before carboplatin. | 358 |
| Bevacizumab-EU Participants received up to a maximum of 6 cycles of Bevacizumab-EU (initial dose was 15 mg/kg) plus paclitaxel (initial dose was 200 mg/m\*2) and carboplatin (initial dose was AUC 6, based on participant's pre-existing renal function and desired platelet nadir), followed by Bevacizumab-EU monotherapy until disease progression, unacceptable toxicity, discretion of the investigator, regulatory request, death, withdrawal of consent occurred. All 3 drugs were given by intravenous (IV) infusion on Day 1 in each 21-day cycle and dose reduction was allowed for paclitaxel and carboplatin in response to toxicity. Paclitaxel was administered before carboplatin. | 361 |
| Total | 719 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 136 | 138 |
| Overall Study | Lost to Follow-up | 10 | 15 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Protocol Violation | 3 | 2 |
| Overall Study | Randomized but did not receive treatment | 2 | 3 |
| Overall Study | Withdrawal by Subject | 14 | 14 |
Baseline characteristics
| Characteristic | PF-06439535 | Bevacizumab-EU | Total |
|---|---|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 9.5 | 60.9 years STANDARD_DEVIATION 8.9 | 61.3 years STANDARD_DEVIATION 9.2 |
| Age, Customized 18-44 years | 19 Participants | 17 Participants | 36 Participants |
| Age, Customized 45-64 years | 198 Participants | 222 Participants | 420 Participants |
| Age, Customized >= 65 years | 141 Participants | 122 Participants | 263 Participants |
| Race/Ethnicity, Customized ASIAN | 36 Participants | 40 Participants | 76 Participants |
| Race/Ethnicity, Customized BLACK | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized OTHER | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized WHITE | 319 Participants | 319 Participants | 638 Participants |
| Sex/Gender, Customized Female | 121 Participants | 131 Participants | 252 Participants |
| Sex/Gender, Customized Male | 237 Participants | 230 Participants | 467 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 144 / 356 | 149 / 358 | 293 / 714 |
| other Total, other adverse events | 328 / 356 | 333 / 358 | 661 / 714 |
| serious Total, serious adverse events | 81 / 356 | 80 / 358 | 161 / 714 |
Outcome results
Primary
Objective Response Rate (ORR) by Week 19
ORR refers to percentage of participants who achieved complete response (CR) or partial response (PR) by Week 19 of the study in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 which was subsequently confirmed by Week 25. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.
Time frame: 25 weeks
Population: The Intent-to-Treat (ITT) population was used for analysis of ORR, and it included all participants who were randomized to study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06439535 | Objective Response Rate (ORR) by Week 19 | 45.3 percentage of participants |
| Bevacizumab-EU | Objective Response Rate (ORR) by Week 19 | 44.6 percentage of participants |
95% CI: [-6.608, 7.9082]
90% CI: [0.8856, 1.1625]
95% CI: [0.8628, 1.1933]
Secondary
Duration of Response (DOR)
DOR was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. DOR was based on the Brookmeyer and Crowley method.
Time frame: 55 weeks
Population: The analysis population included participants in ITT population (all participants who were randomized to study treatment) who had a confirmed objective response achieved by Week 19.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-06439535 | Duration of Response (DOR) | 36.3 weeks |
| Bevacizumab-EU | Duration of Response (DOR) | 28.7 weeks |
p-value: 0.107795% CI: [0.608, 1.051]Log Rank
Secondary
Number of Participants With Anti-Drug Antibody (ADA)
ADA assay was performed using a sensitive, specific, and semi-quantitative electrochemiluminescent (ECL) method, which used biotinylated- and ruthenium-labeled PF-06439535 as reagents. Samples with ADA titer greater than or equal to (\>=) 2.29 were considered positive.
Time frame: 55 weeks
Population: The analysis population included all participants who were randomized and received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06439535 | Number of Participants With Anti-Drug Antibody (ADA) | Cycle 1 pre-dose | 1 Participants |
| PF-06439535 | Number of Participants With Anti-Drug Antibody (ADA) | Overall (post-treatment) | 5 Participants |
| Bevacizumab-EU | Number of Participants With Anti-Drug Antibody (ADA) | Cycle 1 pre-dose | 3 Participants |
| Bevacizumab-EU | Number of Participants With Anti-Drug Antibody (ADA) | Overall (post-treatment) | 5 Participants |
Secondary
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Laboratory evaluation included hematology (hemoglobin, white blood cells, platelets and absolute neutrophil count), blood chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, serum or plasma creatinine, sodium, potassium, total calcium, magnesium, blood urea nitrogen or urea, and albumin ), coagulation (international normalized ratio for prothrombin time and activated partial thromboplastin time) and urinalysis (dipstick followed by a quantitative urine protein analysis for results of 2+ or greater).
Time frame: 55 weeks
Population: The analysis population included all participants who were randomized and received at least 1 dose of study treatment, and had laboratory evaluation done.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06439535 | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 303 Participants |
| Bevacizumab-EU | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 304 Participants |
Secondary
Number of Participants With Neutralizing Antibody (NAb)
Only samples that were confirmed positive for ADA were further tested for NAb. The NAb analysis was conducted using a single validated quasi-quantitative enzyme-linked immunosorbent assay (ELISA) that utilized PF-06439535 as a reagent. Samples with NAb titer \>=1.70 were considered positive.
Time frame: 55 weeks
Population: The analysis population included all participants who had positive ADA results at any time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06439535 | Number of Participants With Neutralizing Antibody (NAb) | Cycle 1 pre-dose | 1 Participants |
| PF-06439535 | Number of Participants With Neutralizing Antibody (NAb) | Overall (post-treatment) | 0 Participants |
| Bevacizumab-EU | Number of Participants With Neutralizing Antibody (NAb) | Cycle 1 pre-dose | 0 Participants |
| Bevacizumab-EU | Number of Participants With Neutralizing Antibody (NAb) | Overall (post-treatment) | 3 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events
AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Time frame: 55 weeks
Population: The analysis population included all participants who were randomized and received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06439535 | Number of Participants With Treatment-Emergent Adverse Events | All-causality SAE | 81 Participants |
| PF-06439535 | Number of Participants With Treatment-Emergent Adverse Events | Grade 2 all-causality AE | 141 Participants |
| PF-06439535 | Number of Participants With Treatment-Emergent Adverse Events | Bevacizumab-related SAE | 23 Participants |
| PF-06439535 | Number of Participants With Treatment-Emergent Adverse Events | Grade 3 all-causality AE | 125 Participants |
| PF-06439535 | Number of Participants With Treatment-Emergent Adverse Events | Bevacizumab-related AE | 190 Participants |
| PF-06439535 | Number of Participants With Treatment-Emergent Adverse Events | Grade 4 all-causality AE | 25 Participants |
| PF-06439535 | Number of Participants With Treatment-Emergent Adverse Events | Grade 1 all-causality AE | 32 Participants |
| PF-06439535 | Number of Participants With Treatment-Emergent Adverse Events | Grade 5 all-causality AE | 21 Participants |
| PF-06439535 | Number of Participants With Treatment-Emergent Adverse Events | All-causality AE | 344 Participants |
| Bevacizumab-EU | Number of Participants With Treatment-Emergent Adverse Events | Grade 5 all-causality AE | 24 Participants |
| Bevacizumab-EU | Number of Participants With Treatment-Emergent Adverse Events | All-causality AE | 347 Participants |
| Bevacizumab-EU | Number of Participants With Treatment-Emergent Adverse Events | All-causality SAE | 80 Participants |
| Bevacizumab-EU | Number of Participants With Treatment-Emergent Adverse Events | Bevacizumab-related AE | 199 Participants |
| Bevacizumab-EU | Number of Participants With Treatment-Emergent Adverse Events | Bevacizumab-related SAE | 17 Participants |
| Bevacizumab-EU | Number of Participants With Treatment-Emergent Adverse Events | Grade 1 all-causality AE | 41 Participants |
| Bevacizumab-EU | Number of Participants With Treatment-Emergent Adverse Events | Grade 2 all-causality AE | 134 Participants |
| Bevacizumab-EU | Number of Participants With Treatment-Emergent Adverse Events | Grade 3 all-causality AE | 104 Participants |
| Bevacizumab-EU | Number of Participants With Treatment-Emergent Adverse Events | Grade 4 all-causality AE | 44 Participants |
Secondary
Progression Free Survival Rate at 55 Weeks
This outcome measure refers to the possibility of being progression free at 55 weeks since start of study treatment, estimated from the Kaplan-Meier curve using the product-limit method.
Time frame: 55 weeks
Population: The ITT population was used for analysis, and it included all participants who were randomized to study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06439535 | Progression Free Survival Rate at 55 Weeks | 32.3 percentage of participants |
| Bevacizumab-EU | Progression Free Survival Rate at 55 Weeks | 30.5 percentage of participants |
p-value: 0.449295% CI: [0.777, 1.116]Log Rank
Secondary
Serum Concentration of Bevacizumab up to 1 Year
Time frame: Pre-dose from Cycle 1 to Cycle 17, 2.5 hours post-dose in Cycle 1, and 1.5 hours post-dose in Cycle 5
Population: The analysis population included all participants in the per-protocol population (all participants who were randomized and received study treatment as planned and had no major protocol deviations) who had at least 1 drug concentration measurement after administration of study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 5 | 105300 ng/mL | Standard Deviation 48469 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 9 | 127200 ng/mL | Standard Deviation 46200 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 3 | 81090 ng/mL | Standard Deviation 48671 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 10 | 125700 ng/mL | Standard Deviation 50769 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | 1.5 hours post-dose in Cycle 5 | 360700 ng/mL | Standard Deviation 131170 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 11 | 129500 ng/mL | Standard Deviation 61329 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 2 | 54350 ng/mL | Standard Deviation 44479 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 12 | 135200 ng/mL | Standard Deviation 64560 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 6 | 112000 ng/mL | Standard Deviation 40825 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 13 | 130900 ng/mL | Standard Deviation 58093 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 4 | 100900 ng/mL | Standard Deviation 54979 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 14 | 128000 ng/mL | Standard Deviation 50840 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 7 | 117300 ng/mL | Standard Deviation 53844 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 15 | 134000 ng/mL | Standard Deviation 55933 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | 2.5 hours post-dose in Cycle 1 | 280000 ng/mL | Standard Deviation 103260 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 16 | 137000 ng/mL | Standard Deviation 54813 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 8 | 123600 ng/mL | Standard Deviation 48893 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 17 | 134800 ng/mL | Standard Deviation 86847 |
| PF-06439535 | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 1 | 68.08 ng/mL | Standard Deviation 705.53 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 17 | 127500 ng/mL | Standard Deviation 52784 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 1 | 116.4 ng/mL | Standard Deviation 1032.1 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | 2.5 hours post-dose in Cycle 1 | 302200 ng/mL | Standard Deviation 100360 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 2 | 58930 ng/mL | Standard Deviation 49452 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 3 | 83350 ng/mL | Standard Deviation 32384 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 4 | 99750 ng/mL | Standard Deviation 50531 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 5 | 110000 ng/mL | Standard Deviation 65416 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | 1.5 hours post-dose in Cycle 5 | 377200 ng/mL | Standard Deviation 142250 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 6 | 116700 ng/mL | Standard Deviation 53844 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 7 | 122100 ng/mL | Standard Deviation 47793 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 8 | 126400 ng/mL | Standard Deviation 52985 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 9 | 140900 ng/mL | Standard Deviation 62548 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 10 | 135900 ng/mL | Standard Deviation 53975 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 11 | 135600 ng/mL | Standard Deviation 54531 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 12 | 136300 ng/mL | Standard Deviation 51312 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 13 | 139700 ng/mL | Standard Deviation 53750 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 14 | 136200 ng/mL | Standard Deviation 53439 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 15 | 134000 ng/mL | Standard Deviation 49663 |
| Bevacizumab-EU | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose in Cycle 16 | 128600 ng/mL | Standard Deviation 49742 |
Secondary
Survival Rate at 55 Weeks
This outcome measure refers to the possibility of being alive at 55 weeks since start of study treatment, estimated from the Kaplan-Meier curve using the product-limit method.
Time frame: 55 weeks
Population: The ITT population was used for analysis, and it included all participants who were randomized to study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06439535 | Survival Rate at 55 Weeks | 65.8 percentage of participants |
| Bevacizumab-EU | Survival Rate at 55 Weeks | 64.1 percentage of participants |
p-value: 0.472695% CI: [0.729, 1.157]Log Rank