Breast cancer biosimilar product meets primary endpoint in Phase 3 clinical trial: Aurobindo Pharma

Hyderabad:Aurobindo Pharma Limited has announced that the breast cancer biosimilar product, BP02 (Trastuzumab or biosimilar to Herceptin), developed by its wholly owned subsidiary company, Curateq Biologics Private Limited, has met its primary endpoint in Phase 3 clinical trial (Trial No.: CR201-18).

BP02 has shown equivalent efficacy to Herceptin in regard to its clinical response (overall response rate, ORR), in addition to demonstrating a comparable safety profile. This phase 3 study is a multi-centre, randomized, double-blinded study involving females with metastatic HER2- positive breast cancer. The trial was carried out to demonstrate product equivalence in terms of efficacy vis-àvis EU sourced Herceptin.

Additionally, the trial also compared pharmacokinetics, safety, and immunogenicity of BP02 vs originators product. The trial enrolled a total of 690 patients, who were randomly assigned in a 1:1 ratio to one of the two parallel treatment groups. They received concomitant chemotherapy (docetaxel). The overall response rate fell well within both the FDA risk ratio-based equivalency margin (0.80 - 1.25) and the EMA risk difference-based equivalency margin (-13, +13). The results demonstrated that BP02 met equivalence to Herceptin in terms of clinical response and the safety profiles of the two treatment arms were shown to be comparable during the treatment phase.

Earlier, CuraTeQ completed a randomized, double-blind, parallel three arm Phase 1 study (BP02-101) in healthy volunteers with BP02 and Herceptin sourced from the US and EU. The study included 111 healthy volunteers who were administered a single dose of BP02 or EU-Herceptin or US-Herceptin in a 1:1:1 ratio. The results demonstrated similar bioavailability (point estimate of 1.0) and all the pharmacokinetic parameters were within the equivalency margin of 0.80 -1.25. BP02 was proven to be bioequivalent to Herceptin sourced from the US and EU.

Dr Satakarni Makkapati, CEO, Biosimilars, Vaccines and Peptidessaid, “We are excited by this study outcome. CuraTeQ is in the process of initiating submissions to regulatory agencies starting this quarter. We hope to complete market authorization (MA) application submissions across all key regulated markets in a phased manner, by March 2024. Our first submission will be in India in July 2023.”.

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