Bristol Myers Squibb's Camzyos Fails in Non-Obstructive HCM Trial, Impacting Growth Prospects
Bristol Myers Squibb (BMS) announced on Monday that its heart medication Camzyos (mavacamten) failed to meet its primary endpoints in a Phase III trial for non-obstructive hypertrophic cardiomyopathy (nHCM), dealing a blow to the company's expansion plans for the drug.
Trial Failure and Implications
The ODYSSEY-HCM study, described as the "largest and longest-duration study" in nHCM patients, was designed to evaluate Camzyos' efficacy in improving peak oxygen consumption and other clinical measures. However, the drug did not demonstrate significant benefits compared to placebo.
Dr. Milind Desai, director of the HCM center at the Cleveland Clinic, stated that the results "help us understand that obstructive HCM and non-obstructive HCM are two unique diseases," suggesting that new treatment approaches may be needed for nHCM.
This setback eliminates a potential $1.3 billion label expansion opportunity for Camzyos, according to analysts at BMO Capital Markets. The failure is particularly significant as BMS faces looming patent expirations for key products like Opdivo and Eliquis.
Market Impact and Competitive Landscape
Camzyos, which BMS acquired through its $13.1 billion purchase of MyoKardia in 2020, received FDA approval in 2022 for obstructive HCM. The drug generated $602 million in sales in 2024, with BMS projecting peak sales potential of $4 billion.
The trial failure has sparked debate about the efficacy of cardiac myosin inhibitors in nHCM. This could have implications for competitors like Cytokinetics and Edgewise Therapeutics, which are developing similar drugs. Cytokinetics' aficamten is currently under FDA review for obstructive HCM and in Phase III trials for non-obstructive HCM.
Future Outlook and Pipeline Developments
Despite the setback, BMS remains focused on other growth catalysts. The company is awaiting results from trials of Cobenfy in schizophrenia and Alzheimer's psychosis, expected later this year. Additionally, BMS is evaluating MYK-224, another cardiac myosin inhibitor, for heart failure with preserved ejection fraction (HFpEF).
While the nHCM market opportunity is lost for Camzyos, analysts maintain that its potential in obstructive HCM remains unchanged, with peak sales estimates of $2.7 billion in this indication. BMS has stated it will share detailed results from the ODYSSEY-HCM trial in the future, which may provide further insights into the distinct nature of obstructive and non-obstructive HCM.
References
- BMS’ Camzyos Fails To Show New Cardiomyopathy Benefit in Phase III
According to analysts at BMO Capital Markets, non-obstructive hypertrophic cardiomyopathy would have meant a $1.3 billion label expansion opportunity for Camzyos.
- BMS growth driver Camzyos fails in heart disease trial, denting expansion opportunity
Camzyos came up short in a phase 3 trial weighing its use in patients with non-obstructive hypertrophic cardiomyopathy (nHCM). In 2022, the drug won FDA approval to treat certain patients with obstructive HCM.
- Bristol Myers stumbles in bid to widen heart drug’s use
Camzyos’ failure in a form of hypertrophic cardiomyopathy dampened its commercial outlook and spurred debate as to whether other drugs like it would similarly struggle in testing.
Explore Further
What are the clinical trial designs and endpoints for other cardiac myosin inhibitors in development for non-obstructive HCM?
How does the competitive landscape look for cardiac myosin inhibitors targeting obstructive versus non-obstructive HCM?
What are the annual sales figures for marketed competitors of Camzyos in the obstructive HCM market?
What is the projected market size for drugs targeting non-obstructive hypertrophic cardiomyopathy?
What insights can be expected from the detailed results of the ODYSSEY-HCM trial concerning the distinct nature of obstructive and non-obstructive HCM?