A Prospective, Randomized, Multiple-Dose, Multi-Center, Comparative Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity of a biosimilar Bevacizumab (Test product, Hetero) and Reference Medicinal Product (Bevacizumab, Roche) in Patients of Metastatic Colorectal Cancer.

ABSTRACT

OBJECTIVE:To compare efficacy and safety of a biosimilar, Bevacizumab (Hetero) vs reference medicinal product (Bevacizumab, Roche) as first line therapy in patients with metastatic colorectal cancer (mCRC) in combination with chemotherapy. METHODS: Patients of aged 18 to 65 with histologically pre-confirmed mCRC and treatment naïve with unresectable metastatic disease or distant metastases were enrolled and randomized to receive either Hetero-Bevacizumab or RMPBevacizumab along with chemotherapy (XELOX or FOLFOX-4) regimen over a period of 24 weeks (up to 8 cycles of Hetero-Bevacizumab/RMP-Bevacizumab+ XELOX regimen (each cycle of 3 weeks) or up to 12 cycles of Hetero-Bevacizumab/ RMP-Bevacizumab + FOLFOX-4 regimen (each cycle of 2 weeks). Bevacizumab was administered at 7.5 mg/kg as an IV infusion over 60-90 minutes on Day 1 of each treatment cycle. The efficacy endpoints were the overall response rate (CR+PR) and disease control rate (DCR) according to RECIST 1.1. The safety endpoints included assessments of treatment emergent adverse events and immunogenicity. RESULTS: 160 patients were screened; 111 patients were randomized in the study. No statistical significant difference in overall response rate between both the treatment groups (HB-MAB vs. RB-MAB 35.56 % vs. 20%, P=0.28 at Week 6; 37.50 % vs. 30.77 %, P=0.73 at Week 12). Similar trend was observed for disease control rate (HB-MAB vs. RB-MAB 100% vs. 96%, P=0.36 at Week 6; 95.83 vs. 100%, P=1.00 at Week 12). CONCLUSIONS: Herero's Bevacizumab was found to be comparable to reference medical product, Bevacizumab in terms of efficacy and tolerability for the Indian patients with metastatic colorectal cancer.