Abstract 394P
Background
Data regarding the real-world use of bevacizumab biosimilar are limited from India. This abstract is focused on the safety and efficacy of biosimilar bevacizumab in the ovarian cancer (OC) cohort in a Phase-4 study from India.
Methods
This multi-center, single-arm, open-label, Phase-4 study assessed 225 patients, with almost half of them (n=112) being advanced OC patients. OC patients were administered biosimilar bevacizumab at 10/15 mg/kg depending on the line of therapy (frontline, platinum-sensitive relapse [PSR], or platinum-resistant relapse [PRR]) in combination with chemotherapy followed by maintenance as monotherapy. Total duration of study participation by each patient was 7 months.
Results
All patients were assessed for safety while efficacy was assessed for per protocol population. Among the OC cohort (n=112), 67 patients underwent surgery for primary disease and 65 patients completed the scheduled treatment while 47 discontinued the treatment (major reasons: patient decision-18, disease progression–10). The most commonly reported (≥10%) adverse events (AEs) in the study were weight loss in 16 (14.3%), followed by anemia, vomiting, and nausea (13 [11.6%] each). Serious AEs were reported in 18 patients (16.07%). Four patients reported grade 3 AEs of special interest, namely enterocutaneous fistula, female genital tract fistula, jejunal perforation, and hypersensitivity. Four deaths were reported in this study, but none was related to the drug. Among the OC efficacy population (n=99), overall response rate (ORR) and disease control rate (DCR) were reported as 46.5% and 74.7%, with no assessment for 18 patients (adjusted ORR=56.8%). ORR among PSR patients (n=43) was 65% and among PRR patients (n=18) was 33% (5 patients were frontline and 31 patients lacked platinum sensitivity assessment).
Conclusions
Among the OC efficacy population (n=99), overall response rate (ORR) and disease control rate (DCR) were reported as 46.5% and 74.7%, with no assessment for 18 patients (adjusted ORR=56.8%). ORR among PSR patients (n=43) was 65% and among PRR patients (n=18) was 33% (5 patients were frontline and 31 patients lacked platinum sensitivity assessment).
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Biocon Biologics Ltd.
Funding
Biocon Biologics Ltd.
Disclosure
S. Deodhar, R. Kapur, K.H. Upveja: Financial Interests, Institutional, Full or part-time Employment: Biocon Biologics Ltd. All other authors have declared no conflicts of interest.