Amgen/Cytokinetics Phase III Heart Failure Data Are Below Expectations

Omecamtiv Met Primary, Missed Key Secondary Endpoints

Analysts considered the Phase III GALACTIC-HF study of omecamtiv mecarbil a failure but some anticipated that detailed data to be presented next month could at least partially redeem the drug.

Paper heart
Omecamtiv reduced a composite of hospitalizations and deaths with no significant impact on deaths alone • Source: Shutterstock

Top-line results from the massive Phase III clinical trial of Amgen, Inc.’s and Cytokinetics, Inc.’s omecamtiv mecarbil in the treatment of heart failure with reduced ejection fraction (HFrEF) are mixed, at best. The initial data shared on 8 October showed that the GALACTIC-HF trial succeeded on the primary endpoint but a crucial secondary endpoint was missed, raising questions about whether the selective cardiac myosin activator can be approved and become a viable commercial product.

Omecamtiv met the 8,256-patient study’s primary composite endpoint of reduction in heart failure events (hospitalizations and other urgent treatments) and cardiovascular deaths with statistical significance versus placebo (HR: 0.92; 95% CI: 0.86, 0.99, p=0.0252)

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