Trial Outcomes & Findings for A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NCT NCT02754882)

Last Updated: 2024-12-16

Results Overview

The best ORR was defined as the proportion of subjects whose best overall response was either Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 during the induction treatment period by 24 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

763 participants

Primary outcome timeframe

24 weeks from randomisation

Results posted on

2024-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Bevacizumab (Avastin) Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles	SB8 (A Proposed Bevacizumab Biosimilar) SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Overall Study STARTED	384	379
Overall Study COMPLETED	38	35
Overall Study NOT COMPLETED	346	344

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab (Avastin) n=384 Participants Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles	SB8 (A Proposed Bevacizumab Biosimilar) n=379 Participants SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles	Total n=763 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	269 Participants n=5 Participants	255 Participants n=7 Participants	524 Participants n=5 Participants
Age, Categorical >=65 years	115 Participants n=5 Participants	124 Participants n=7 Participants	239 Participants n=5 Participants
Age, Continuous	60.0 years STANDARD_DEVIATION 9.18 • n=5 Participants	60.2 years STANDARD_DEVIATION 8.95 • n=7 Participants	60.1 years STANDARD_DEVIATION 20.84 • n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	127 Participants n=7 Participants	255 Participants n=5 Participants
Sex: Female, Male Male	256 Participants n=5 Participants	252 Participants n=7 Participants	508 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	348 Participants n=5 Participants	347 Participants n=7 Participants	695 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index (BMI)	25.49 kg/m^2 STANDARD_DEVIATION 4.707 • n=5 Participants	25.50 kg/m^2 STANDARD_DEVIATION 4.809 • n=7 Participants	25.50 kg/m^2 STANDARD_DEVIATION 4.755 • n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks from randomisation

Population: The Full Analysis Set consisted of all randomised subjects. The subjects were analysed based on the treatment they were randomised to by intention-to-treat principle. However, subjects who did not qualify for randomisation and were inadvertently randomised into the study were excluded from FAS, provided these subjects did not receive any IP, and there was one subject who met these criteria. So, there is a difference between "Started" in Participant Flow module and Analysis Population.

Outcome measures

Outcome measures
Measure	Bevacizumab (Avastin) n=383 Participants Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles	SB8 (A Proposed Bevacizumab Biosimilar) n=379 Participants SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks	42.8 percentage of participants	47.6 percentage of participants

SECONDARY outcome

Timeframe: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject

Population: Full Analysis Set (FAS): Consisted of all randomised subjects. The subjects were analysed based on the treatment they were randomised to by intention-to-treat principle. Per-protocol Set (PPS): Consisted of all FAS subjects who completed at least first 2 cycles of combination chemotherapy with a tumour assessment and did not have any major protocol deviations that impacted the primary efficacy assessment.

PFS is defined as the time from the date of Randomisation to the date of disease progression (progressive disease \[PD\]) or death regardless of the cause of death. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Outcome measures
Measure	Bevacizumab (Avastin) n=379 Participants Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles	SB8 (A Proposed Bevacizumab Biosimilar) n=383 Participants SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Progression Free Survival FAS	8.50 months Interval 7.4 to 9.7	7.90 months Interval 7.4 to 9.5
Progression Free Survival PPS	8.50 months Interval 7.2 to 9.7	7.90 months Interval 7.3 to 9.4

SECONDARY outcome

Timeframe: from the date of randomisation to the date of death up to 12 months from randomisation of the last subject

OS was defined as the time from the date of randomisation to the date of death regardless of the cause of death. Subjects who were alive at the time of analysis were censored at the date of last known alive.

Outcome measures

Outcome measures
Measure	Bevacizumab (Avastin) n=379 Participants Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles	SB8 (A Proposed Bevacizumab Biosimilar) n=383 Participants SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Overall Survival PPS	14.80 months Interval 13.0 to 17.1	15.80 months Interval 13.8 to 17.7
Overall Survival FAS	14.90 months Interval 13.3 to 17.1	15.80 months Interval 13.6 to 17.1

SECONDARY outcome

Timeframe: from documented tumour response until disease progression up to 12 months from randomisation of the last subject

DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject

Outcome measures

Outcome measures
Measure	Bevacizumab (Avastin) n=379 Participants Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles	SB8 (A Proposed Bevacizumab Biosimilar) n=383 Participants SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Duration of Response (DoR) FAS	6.38 months Standard Deviation 3.773	6.79 months Standard Deviation 4.117
Duration of Response (DoR) PPS	6.33 months Standard Deviation 3.784	6.81 months Standard Deviation 4.177

SECONDARY outcome

Timeframe: AEs were reported from the time the informed consent form (ICF) was signed until the EOT visit, approximately 24 months from study initiation.

Population: Safety Set (SAF): The Safety Set consisted of all subjects who received the study drug at least once.

After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them. Severity Grade of NCI-CTCAE v4.03 Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) (Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self-care ADL (Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.) Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE

Outcome measures

Outcome measures
Measure	Bevacizumab (Avastin) n=378 Participants Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles	SB8 (A Proposed Bevacizumab Biosimilar) n=380 Participants SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 TEAEs	348 Participants	346 Participants
Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 CTCAE Grade 1	47 Participants	57 Participants
Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 CTCAE Grade 2	127 Participants	134 Participants
Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 CTCAE Grade 3	119 Participants	97 Participants
Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 CTCAE Grade 4	33 Participants	31 Participants
Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 CTCAE Grade 5	22 Participants	27 Participants

SECONDARY outcome

Timeframe: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)

Population: Pharmacokinetic Population (PK Population): This set consisted of subjects allocated to PK sub-study who had at least one measured serum concentration of bevacizumab. PK analyses were performed on the PK population. The number of participants analyzed in each Cycle is the number of participants in PK population with non-missing values or without protocol deviation for PK blood sampling at the cycle.

Ctrough at selected cycles (i.e., Cycle 1, 3, 5 and 7)

Outcome measures

Outcome measures
Measure	Bevacizumab (Avastin) n=161 Participants Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles	SB8 (A Proposed Bevacizumab Biosimilar) n=180 Participants SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Pharmacokinetics: Trough Level [Ctrough] Cycle 1	0.0000 ug/mL Standard Deviation 0.00000	0.0000 ug/mL Standard Deviation 0.00000
Pharmacokinetics: Trough Level [Ctrough] Cycle 3	83.7568 ug/mL Standard Deviation 44.49701	102.3939 ug/mL Standard Deviation 69.36822
Pharmacokinetics: Trough Level [Ctrough] Cycle 5	109.0906 ug/mL Standard Deviation 50.65915	119.9343 ug/mL Standard Deviation 54.65786
Pharmacokinetics: Trough Level [Ctrough] Cycle 7	121.7382 ug/mL Standard Deviation 62.62150	133.7669 ug/mL Standard Deviation 58.84136

SECONDARY outcome

Timeframe: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)

Maximum Plasma Concentration (Cmax) at selected cycles (i.e., Cycle 1, 3, 5 and 7)

Outcome measures

Outcome measures
Measure	Bevacizumab (Avastin) n=161 Participants Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles	SB8 (A Proposed Bevacizumab Biosimilar) n=180 Participants SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Pharmacokinetics: Maximum Plasma Concentration [Cmax] Cycle 1	306.0352 ug/mL Standard Deviation 98.71872	302.6362 ug/mL Standard Deviation 87.10467
Pharmacokinetics: Maximum Plasma Concentration [Cmax] Cycle 3	374.9657 ug/mL Standard Deviation 106.54366	399.4598 ug/mL Standard Deviation 136.27431
Pharmacokinetics: Maximum Plasma Concentration [Cmax] Cycle 5	389.3132 ug/mL Standard Deviation 123.07791	397.6183 ug/mL Standard Deviation 125.84175
Pharmacokinetics: Maximum Plasma Concentration [Cmax] Cycle 7	397.5435 ug/mL Standard Deviation 120.74092	426.1350 ug/mL Standard Deviation 144.24538

SECONDARY outcome

Timeframe: Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation.

Population: The analysis was performed using the Safety Set (SAF). The SAF consisted of all subjects who received the study drug at least once. This analysis set was used for the safety analyses. The subjects were analysed based on the treatment they received. There were 4 subjects in Avastin group and 1 subject in SB8 group who had not received any IP or non-IP treatment.

Incidence of anti-drug (bevacizumab) antibodies (ADA) The incidence of overall ADA results (i.e. Positive, Negative, Inconclusive) was presented by treatment group at Cycle 7 and the end of treatment (EOT). Overall ADA result was defined as below: * 'Positive' for a subject with treatment-induced or treatment-boosted ADA, where treatment-induced ADA indicated at least one positive result after pre-dose of Cycle 1 for subjects with negative ADA at pre-dose of Cycle 1, and treatment-boosted ADA indicated at least one positive result with higher titre level compared to pre-dose of Cycle 1 after pre-dose of Cycle 1 for subjects with positive ADA at pre-dose of Cycle 1. * 'Negative' for a subject without positive ADA until Cycle 7 and EOT. * 'Inconclusive' for a subject with positive ADA at Cycle 1 and without positive result with higher titre level observed after pre-dose of Cycle 1 up to Cycle 7 and EOT.

Outcome measures

Outcome measures
Measure	Bevacizumab (Avastin) n=378 Participants Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles	SB8 (A Proposed Bevacizumab Biosimilar) n=380 Participants SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 1 (BL) · Positive	15 Participants	15 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 1 (BL) · Negative	357 Participants	356 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 1 (BL) · Inconclusive (only applicable for "Overall")	0 Participants	0 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 3 · Positive	29 Participants	22 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 3 · Negative	309 Participants	316 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 3 · Inconclusive (only applicable for "Overall")	0 Participants	0 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 5 · Positive	15 Participants	21 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 5 · Negative	286 Participants	275 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 5 · Inconclusive (only applicable for "Overall")	0 Participants	0 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 7 · Positive	28 Participants	20 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 7 · Negative	238 Participants	259 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 7 · Inconclusive (only applicable for "Overall")	0 Participants	0 Participants
Immunogenicity Assessments (Anti-drug Antibodies) EOT · Positive	21 Participants	9 Participants
Immunogenicity Assessments (Anti-drug Antibodies) EOT · Negative	129 Participants	152 Participants
Immunogenicity Assessments (Anti-drug Antibodies) EOT · Inconclusive (only applicable for "Overall")	0 Participants	0 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 7 Overall · Positive	46 Participants	34 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 7 Overall · Negative	284 Participants	294 Participants
Immunogenicity Assessments (Anti-drug Antibodies) Cycle 7 Overall · Inconclusive (only applicable for "Overall")	11 Participants	9 Participants
Immunogenicity Assessments (Anti-drug Antibodies) EOT Overall · Positive	55 Participants	37 Participants
Immunogenicity Assessments (Anti-drug Antibodies) EOT Overall · Negative	276 Participants	291 Participants
Immunogenicity Assessments (Anti-drug Antibodies) EOT Overall · Inconclusive (only applicable for "Overall")	10 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation.

Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb) The analysis was performed using the Safety Set (SAF). Overall Number of Participants Analyzed represents the number of subjects in SAF. The total number is not the sum of the number of subjects of each visits, since NAb results only for subjects with ADA positive against SB8 or Avastin were used for the summary. Number Analyzed of each visit is equal to the number of subjects with ADA positive of each visit, which is displayed in 8. Secondary Outcome: Immunogenicity Assessments (Anti-drug Antibodies).

Outcome measures

Outcome measures
Measure	Bevacizumab (Avastin) n=378 Participants Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles	SB8 (A Proposed Bevacizumab Biosimilar) n=380 Participants SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Immunogenicity Assessments (Neutralizing Antibodies) EOT · Negative	12 Participants	4 Participants
Immunogenicity Assessments (Neutralizing Antibodies) Cycle 1 (BL) · Positive	0 Participants	1 Participants
Immunogenicity Assessments (Neutralizing Antibodies) Cycle 1 (BL) · Negative	15 Participants	14 Participants
Immunogenicity Assessments (Neutralizing Antibodies) Cycle 3 · Positive	9 Participants	9 Participants
Immunogenicity Assessments (Neutralizing Antibodies) Cycle 3 · Negative	20 Participants	13 Participants
Immunogenicity Assessments (Neutralizing Antibodies) Cycle 5 · Positive	5 Participants	8 Participants
Immunogenicity Assessments (Neutralizing Antibodies) Cycle 5 · Negative	10 Participants	13 Participants
Immunogenicity Assessments (Neutralizing Antibodies) Cycle 7 · Positive	12 Participants	11 Participants
Immunogenicity Assessments (Neutralizing Antibodies) Cycle 7 · Negative	16 Participants	9 Participants
Immunogenicity Assessments (Neutralizing Antibodies) EOT · Positive	9 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 11 weeks and 17 weeks from randomisation

Best Objective Response Rate (ORR) by 11 weeks and 17 weeks

Outcome measures

Outcome measures
Measure	Bevacizumab (Avastin) n=379 Participants Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles	SB8 (A Proposed Bevacizumab Biosimilar) n=383 Participants SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Best Objective Response Rate by 11 and 17 Weeks 17 Weeks (FAS)	159 Participants	152 Participants
Best Objective Response Rate by 11 and 17 Weeks 11 Weeks (PPS)	99 Participants	89 Participants
Best Objective Response Rate by 11 and 17 Weeks 17 Weeks (PPS)	149 Participants	137 Participants
Best Objective Response Rate by 11 and 17 Weeks 11 Weeks (FAS)	107 Participants	100 Participants

Adverse Events

Bevacizumab (Avastin)

Serious events: 81 serious events

Other events: 316 other events

Deaths: 171 deaths

SB8 (A Proposed Bevacizumab Biosimilar)

Serious events: 75 serious events

Other events: 323 other events

Deaths: 166 deaths

Serious adverse events

Other adverse events

Additional Information

Director of Clinical Trials

Samsung Bioepis Co., Ltd

Phone: 031-8061-1096

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place