Abstract 817: A prospective, multi-center, phase IV study to evaluate safety and efficacy of Dr. Reddy’s bevacizumab (DRL_BZ) in patients with solid tumors

Abstract Introduction: DRL_BZ is a biosimilar to the reference product, bevacizumab, and was approved in India and subsequently introduced in other markets for the use in various other solid tumors as single or combination therapy. This study was conducted as part of a post-marketing commitment to regulatory authority aimed to evaluate treatment safety (primary objective), and efficacy (secondary objective) in male and female patients with solid tumors. Methods: In this prospective, single-arm, multicenter, Phase IV study (BZ-01-002), a total of 200 patients with median age 54.0 years were enrolled with the following indications: mCRC (n = 59); NSCLC (n = 41); epithelial ovarian cancer (n = 27), and cervical cancer (n = 73). Patients received DRL_BZ either with chemotherapy or as monotherapy and followed up to disease progression, unacceptable toxicity, or death due to any cause, or up to 6 months from first dose whichever occurs earlier. Results: The overall median duration (days) of DRL_BZ treatment exposure for the enrolled patients was 151.5 (1.0 - 253) days. Of the 200 enrolled patients, 117 (58.5%) patients completed the study, while 83 (41.5%) patients were withdrawn from the study due to various reasons (majorly due to COVID-19 pandemic). Out of 454 TEAEs reported from 139 (69.5%) patients, 46 TEAEs in 25 (12.5%) patients were considered related to DRL_BZ administration. Thirteen (6.5%) TEAEs leading to permanent study drug discontinuation. A total of 13 SAEs in 12 (6%) patients were reported and four of them were related to study drug. As per mITT population, 153 patients were evaluable for efficacy, and the reported ORR was 23.1% (3/13) for 2-weekly mCRC patients, 25% (8/32) for 3-weekly mCRC patients, 45.7% (16/35) for NSCLC patients, 72.7% (16/22) for epithelial ovarian cancer patients, and 37.3% (19/51) for cervical cancer patients. Conclusions: The safety profile of DRL_BZ, in terms of reported adverse events, in patients with solid tumors is comparable and consistent with the known safety profile of bevacizumab in literature. Overall, findings from this Phase IV study indicate that the safety and efficacy of DRL_BZ in patients with solid tumors is as per the approved prescribing information. Citation Format: Narendra Maharaj, Ranjith K, Anand Eswaraiah, Pramod kumar Reddy, Gopichand M, Rajender Singh Arora, Krishna Chaithanya Puligundla, Ashok Kumar Diwan, Tanveer Mohibbhai Maksud. A prospective, multi-center, phase IV study to evaluate safety and efficacy of Dr. Reddy’s bevacizumab (DRL_BZ) in patients with solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 817.