Bristol Myers Squibb Provides Update on Phase 3 ODYSSEY-HCM Trial

Bristol Myers Squibb announced that its Phase 3 ODYSSEY-HCM trial for Camzyos (mavacamten) in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) did not meet its dual primary endpoints. These included improvements from baseline at 48 weeks in the Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-23 CSS) and peak oxygen consumption (pVO2), compared to placebo.

While the trial did not show efficacy in nHCM, no new safety issues were observed. The findings reaffirm the distinct nature of obstructive versus non-obstructive HCM and highlight the need for alternative treatment strategies in the latter.

Camzyos remains approved in the U.S., EU, and over 50 global markets for the treatment of symptomatic obstructive HCM (oHCM), where clinical trials and real-world data continue to support its safety and effectiveness.

The ODYSSEY-HCM trial enrolled 580 patients globally and is the first Phase 3 study of a cardiac myosin inhibitor in non-obstructive HCM. Bristol Myers Squibb plans to share full trial results with the scientific community in the future.