KUALA LUMPUR, March 14 (Bernama) -- Prestige BioPharma Limited, a Singapore-based biopharmaceutical with operations in the USA and South Korea, has announced positive efficacy and safety results of the Phase 3 study for HD201 (TROIKA), a biosimilar to Herceptin® (trastuzumab), published in JAMA Oncology on March 4, 2022.
Prestige BioPharma Chief Executive Officer, Lisa S. Park said: “We are pleased to demonstrate HD201’s excellence through the Phase 3 study results published in JAMA Oncology” and “the company will accelerate global launch of Tuznue that can enhance affordability of trastuzumab to the patients in need.”
According to a statement, the publication highlights comparative efficacy and safety data for patients who received one-year of treatment with HD201 or referent trastuzumab and completed a median follow-up of 31 months.
The study met its primary endpoint (tpCR) and showed equivalent efficacy and comparable safety profile. The tpCR rates were 45 per cent and 48.7 per cent for HD201 and referent trastuzumab, respectively.
The final analysis for the 3-year Event-free survival (EFS) and Overall survival (OS) results is ongoing. The preliminary results of the current final analysis indicate highly comparable 3-year EFS and OS rates for HD201 and reference trastuzumab.
Tuznue® has secured global distribution partnerships in major markets including Europe, the Middle East, South America, and Asia. It is currently under Marketing Authorization Application (MAA) review in EU EMA, Canada and South Korea.
More details at www.prestigebiopharma.com.
-- BERNAMA
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