Aurobindo Pharma has announced positive results from a Phase 3 clinical trial of its breast cancer biosimilar product, BP02 (Trastuzumab or biosimilar to Herceptin), developed by its subsidiary, Curateq Biologics.

The clinical trial demonstrated that BP02 has a comparable efficacy and safety profile to Herceptin.

The trial was a multi-center, randomized, double-blind study involving women with metastatic HER2-positive breast cancer. It aimed to establish the product’s equivalence in terms of efficacy to the EU-sourced Herceptin.

Besides, the late-stage trial compared the pharmacokinetics, safety, and immunogenicity of BP02 to the original product. It involved 690 patients, who were randomly assigned to one of two parallel treatment groups and received concomitant chemotherapy (docetaxel).

The overall response rate matched both the FDA risk ratio-based equivalency margin (0.80 – 1.25) and the EMA risk difference-based equivalency margin (-13, +13). This confirmed that BP02 met equivalence to Herceptin in terms of clinical response, and the safety profiles of the two treatment arms were found to be comparable during the treatment phase.

In a previous randomized, double-blind, parallel three-arm Phase 1 study (BP02-101) in healthy volunteers, Curateq compared BP02 with Herceptin sourced from the US and EU. The study involved 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 showed similar bioavailability and all the pharmacokinetic parameters were within the equivalency margin of 0.80 -1.25. This suggested that BP02 is bioequivalent to Herceptin sourced from the US and EU.

Dr Satakarni Makkapati — Curateq Biologics Biosimilars, Vaccines and Peptides CEO said: “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.”

  Aurobindo Pharma, BP02, Breast Cancer, Curateq Biologics, Dr Satakarni Makkapati, Herceptin, India, trastuzumab