Blog Big Molecule Watch March 21, 2022

JAMA Oncology Publishes Results of Phase III Study for Prestige BioPharma’s HERCEPTIN Biosimilar, HD201

On March 14, 2022, Prestige BioPharma Ltd., a Singapore-based biopharmaceutical company, announced positive safety and efficacy results in a Phase III study (“TROIKA”) for HD201, a biosimilar to HERCEPTIN (trastuzumab). The results of the TROIKA study were published in JAMA Oncology on March 3, 2022.

In the double-blind trial, researchers compared the biosimilar HD201 with HERCEPTIN in patients with ERBB2-positive early breast cancer. The study enrolled a total of 502 female patients across 70 sites in 12 countries. The patients were randomly assigned to receive HD201 or HERCEPTIN as neoadjuvant therapy for 8 cycles, in combination with other drugs. After surgery, patients received 10 cycles of either HD201 or HERCEPTIN.

The study met its primary endpoint (total pathological complete response or tpCR) and showed equivalent efficacy and comparable safety profile to HERCEPTIN, with tpCR rates of 45% for HD201 and 48.7% for HERCEPTIN. The difference between the two groups was not significant and fell within the predefined equivalence margins. The final analysis for the 3-year Event-free survival (EFS) and Overall survival (OS) results is currently ongoing.

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