- Bristol Myers Squibb's Phase 3 ODYSSEY-HCM trial did not meet its dual primary endpoints for non-obstructive hypertrophic cardiomyopathy (nHCM).
- 580 patients were involved in the trial, assessing changes in Kansas City Cardiomyopathy Questionnaire scores and peak oxygen consumption.
- The trial results do not affect the established benefit-risk profile of Camzyos for obstructive HCM, which remains approved in over 50 countries.
In a significant development for Bristol Myers Squibb (BMY, Financial), the Phase 3 ODYSSEY-HCM trial failed to meet its dual primary endpoints for non-obstructive hypertrophic cardiomyopathy (nHCM). The trial assessed 580 adult participants and aimed to evaluate improvements in the Kansas City Cardiomyopathy Questionnaire scores and peak oxygen consumption by Week 48 compared to a placebo.
Despite this setback, there were no new safety signals observed during the trial. The company emphasized that the results do not alter Camzyos's established benefits for obstructive hypertrophic cardiomyopathy (oHCM) patients. Camzyos, a cardiac myosin inhibitor, has demonstrated favorable outcomes in both clinical trials and real-world evidence across more than 50 countries for oHCM.
The trial underscored a critical scientific distinction between obstructive and non-obstructive HCM, suggesting that cardiac myosin inhibitors like Camzyos may have varied effects across different HCM variants. As a consequence, the opportunity to expand Camzyos into the nHCM market appears limited for the near term, maintaining a significant unmet medical need for this patient population.
This outcome highlights the complexities involved in cardiovascular drug development and places a ceiling on the drug's growth trajectory for the nHCM indication. Bristol Myers Squibb continues to prioritize sharing the trial results with the scientific community and remains committed to addressing the needs of patients with obstructive HCM.
