Abstract
COMPARISON OF THE EFFECT OF A BIOSIMILAR BEVACIZUMAB WITH THE INNOVATORS’ BEVACIZUMAB IN THE TREATMENT OF NON-SMALL-CELL LUNG CANCER

Deven Parmar*, Jayesh K. Bhatt, Manjunath K., Farheen Arifahmed, Krupi Parmar and Chintan Shah

ABSTRACT

Aim: The role of bevacizumab in combination with carboplatin/paclitaxel chemotherapy has been established in patients with non-small-cell lung cancer (NSCLC). This trial was designed to compare the effect of the Zydus biosimilar bevacizumab with the reference bevacizumab in patients with NSCLC. Methods: A multicentre, prospective, randomized, open-label, active controlled study was carried out on 248 subjects with advanced, unresectable, recurrent or metastatic NSCLC at 28 sites across India. Subjects were randomized in a 2:1 ratio to receive intravenous infusion of 15 mg/kg of test or reference bevacizumab, plus paclitaxel 175 mg/m2 and carboplatin (AUC 5 mg/mL×min) every 3 weeks for 6 cycles. Overall response rate (ORR) after 6 cycles was assessed by using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Pharmacokinetics, safety and tolerability, and immunogenicity were also assessed. Results: The ORR was 60.82% responders in the Zydus bevacizumab and 58.82% responders in the reference bevacizumab and the 90% confidence interval (CI) for the difference of ORR fell within the ±20% equivalence margin (-11.96, 15.97). The pharmacokinetic assessment of the Ln-transformed bevacizumab after Cycle-1 data showed the 90% CI for the ratio of the test to reference geometric least square mean fell within the 80.00-125.00% limits for Cmax (87.99%; 120.41%) and AUC0-t (90.70%; 122.03%). The incidence of immunogenicity was marginally lower in the test group as compared to the reference group (72.16% vs. 76.47%). Conclusion: The results demonstrated biosimilarity between Zydus and reference bevacizumab with respect to efficacy, tolerability and safety in the patients with NSCLC.

Keywords: NSCLC, bevacizumab, biosimilar, ORR, pharmacokinetics, immunogenicity.


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