Prothena announces Phase 3 VITAL results published in Blood journal

Prothena Corporation plc announced the publication of the Phase 3 VITAL clinical trial in Blood, a journal of the American Society of Hematology. 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 versus 49 percent in patients on placebo plus SOC at 9 months. All participants in the clinical trial received concomitant bortezomib-containing chemotherapy regimens as part of SOC. “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.”