Aurobindo Pharma subsidiary meets end points for Phase 3 clinical trial of Trastuzumab

5 Jul 2023 , 09:59 AM

Aurobindo Pharma Limited announced that its breast cancer biosimilar product, BP02 (Trastuzumab or biosimilar to Herceptin), met its primary endpoint in the Phase 3 clinical trial (Trial No.: CR201-18).

The said biosimilar is developed by Aurobindo’s wholly-owned subsidiary company, Curateq Biologics Private Limited.

BP02 has demonstrated comparable efficacy to Herceptin in terms of clinical response (overall response rate, ORR), as well as a comparable safety profile.

The phase 3 trial is a multi-center, randomized, double-blind study of females with metastatic HER2-positive breast cancer. The trial was conducted to show product equivalence in terms of efficacy when compared to Herceptin sourced from the EU.

The trial was conducted on 690 patients who were randomly assigned to one of two parallel treatment groups in a 1:1 ratio. They were given chemotherapy (docetaxel) at the same time.

The general response rate was well within the FDA risk ratio-based equivalency margin (0.80-1.25), as well as the EMA risk difference-based equivalency margin (-13, +13).

The results showed that BP02 had clinical response equivalence to Herceptin and that the safety profiles of the two treatment arms were comparable during the treatment phase.

At around 9.55 AM, Aurobindo Pharma was trading 1.45% higher at Rs 722.95, against the previous close of Rs 712.65 on NSE. The counter touched an intraday high of Rs 723.40.

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