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Prothena Announces Phase 3 VITAL Clinical Trial Results Published in Blood Showing Survival Benefit in Patients with Mayo Stage IV AL Amyloidosis Treated with Birtamimab
First time published in a peer-reviewed journal: birtamimab is the only investigational drug that has shown a significant survival benefit in patients with
About this update from Prothena Corporation Plc
[{"type":"text","content":"\n\nFirst time published in a peer-reviewed journal: birtamimab is the only investigational drug that has shown a significant survival benefit in patients with Mayo Stage IV AL amyloidosis in a double-blind placebo-controlled clinical trial\n\n\n\nA significant improvement in time to all-cause mortality at month 9 was observed with birtamimab versus placebo and remained consistent across all key baseline variables in a post hoc analysis of patients with Mayo Stage IV AL amyloidosis\n\n\n\nBirtamimab is currently being studied in the confirmatory Phase 3 clinical trial, AFFIRM-AL, in patients with Mayo Stage IV AL amyloidosis; topline data is expected in 2024\n\n\n\n DUBLIN--(BUSINESS WIRE)--\nProthena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced the publication of the Phase 3 VITAL clinical trial in Blood, a journal of the American Society of Hematology (ASH). The published data demonstrate that in a post hoc analysis of patients with Mayo Stage IV AL amyloidosis, a statistically significant survival benefit of 74 percent was observed for those treated with birtamimab plus standard of care (SOC) versus 49 percent in patients on placebo plus SOC at 9 months (HR 0.413, p=0.021). All participants in the clinical trial received concomitant bortezomib-containing chemotherapy regimens as part of SOC.\n\n\n“For the first time, we have these important data published in a prestigious, peer-reviewed journal which show that treatment with birtamimab led to a survival benefit in patients with Mayo Stage IV AL amyloidosis and affirms its potential as a safe, well-tolerated and effective therapy,” said Morie Gertz, MD, Hematologist, Chair emeritus Internal Medicine, Mayo Clinic. “AL amyloidosis is a rare and life-threatening disease in which patients have no treatment options despite the high fatality rate. We look forward to learning more about the survival benefit of birtamimab in patients with Mayo Stage IV AL amyloidosis from the confirmatory Phase 3 AFFIRM-AL clinical trial.”\n\n\nThe article, entitled “Birtamimab plus standard of care in light chain amyloidosis: the phase 3 randomized placebo-controlled VITAL clinical trial”, also includes new data showing that there was no observed difference in...