Abstract 1377P
Background
The equivalence between SB8, a proposed bevacizumab biosimilar, and the reference bevacizumab (BEV) in terms of the best overall response rate (ORR) in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) was previously reported (M. Reck et al, 1565P, Ann. Oncol, Vol 30, Supp. 5, 2019). Here, we show results of exploratory analyses to further support equivalent clinical efficacy between SB8 and BEV.
Methods
Patients received SB8 or BEV with paclitaxel and carboplatin Q3W up to 6 cycles followed by SB8 or BEV maintenance monotherapy. The primary endpoint was best ORR by 24 weeks of the induction treatment period. Additionally, best ORR by 11 and 17 weeks was analysed and maximum percentage change from baseline in tumour burden by 11, 17, and 24 weeks of the induction treatment period were assessed. Subgroup analyses by age group, gender, cancer type, ECOG performance status, smoking status, and status of distant metastasis were conducted. Sensitivity analysis adjusted for the status of distant metastasis were also performed for the primary endpoint.
Results
665 patients (SB8, n=337; BEV, n=328) were included in the per-protocol set. Previously reported best ORR by 24 weeks was 50.1% in SB8 and 44.8% in BEV. The risk difference in best ORR by 11 and 17 weeks was 2.2% with 95% CI of [−4.6%, 9.1%] and 2.4% with 95% CI of [−5.1%, 10.0%], both of which were entirely contained within the pre-defined equivalence margins. There was no difference in the mean of maximum percentage change from baseline in tumour burden between SB8 and BEV by 11, 17, and 24 weeks of the induction treatment period with the 24 weeks results being −27.8% for SB8 and −27.3% for BEV with a difference of 0.59% (p-value: 0.7452). The subgroup analysis of the risk differences in best ORR showed comparable treatment effects within each subgroup. Sensitivity analysis adjusting for the status of distant metastasis result was also consistent with the overall results.
Conclusions
These exploratory analyses of the best ORR and maximum percentage change from baseline in tumour burden between SB8 and BEV further support equivalence between SB8 and BEV.
Clinical trial identification
NCT02754882.
Editorial acknowledgement
Legal entity responsible for the study
Samsung Bioepis Co., Ltd.
Funding
Samsung Bioepis Co., Ltd.
Disclosure
D. Planchard: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: Celgene; Advisory/Consultancy, Research grant/Funding (self): Daiichi Sankyo; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Eli Lilly; Research grant/Funding (self): Medimmun; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Merck; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Novartis; Research grant/Funding (self): Novocure; Honoraria (self), Advisory/Consultancy: Peer CME; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Pfizer; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: prIME Oncology; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: Roche; Honoraria (self): Samsung Bioepis; Research grant/Funding (self): Sanofi-Aventis; Research grant/Funding (self): Taiho Pharma. D. Shin, J. Choi, Y. Seo, J.A. Jung, M. Park: Full/Part-time employment: Samsung Bioepis. M. Reck: Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory/Consultancy: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy: Celgene; Honoraria (self), Advisory/Consultancy: Lilly; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Samsung Bioepis.