Curateq Biologics, a subsidiary of Aurobindo Pharma, has reported that its Phase III clinical trial of trastuzumab biosimilar product BP02, for the treatment of breast cancer, has met its primary endpoint.
The double-blinded, randomised, multi-centre study has been designed for determining the product equivalence of BP02 in terms of efficacy against EU sourced Herceptin.
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It also evaluated the immunogenicity, pharmacokinetics, and safety of BP02 against parallel treatment groups, including chemotherapy (docetaxel).
A total of 690 women with metastatic HER2-positive breast cancer were randomised into a 1:1 ratio into one of the two parallel treatment groups.
The overall response was found to be within the EMA risk difference-based equivalency margin (-13, +13) and the FDA risk ratio-based equivalency margin (0.80-1.25).
BP02 showed similar clinical responses compared to Herceptin, and its safety profiles were also observed to be equivalent during the treatment phase.
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By GlobalDataAurobindo Biosimilars, Vaccines and Peptides CEO Dr Satakarni Makkapati said: “CuraTeQ is in the process of initiating submissions to regulatory agencies starting this quarter.
“We hope to complete market authorisation (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.”
BP02 and Herceptin sourced from the US and EU were also assessed in an earlier Phase I study in 111 healthy volunteers.
They were randomised into a 1:1:1 ratio to receive either a single dose of BP02, EU-Herceptin, or US-Herceptin. Bioavailability and all pharmacokinetic parameters were found to be equivalent during the study duration.
