Cytokinetics competes with BMS' Camzyos

Cytokinetics has embarked on a mission to position its experimental drug, aficamten, as a formidable contender to Bristol Myers Squibb’s $13.1 billion heart disease medication, Camzyos. This new analysis provides an opportunity for a direct comparison between aficamten and Camzyos, with recent phase 3 data highlighting improvements in exercise capacity among patients.

Having achieved primary endpoint success in December 2023, Cytokinetics presented a comprehensive suite of phase 3 data from the SEQUOIA-HCM trial at the European Society of Cardiology Heart Failure 2024 Congress. The headline results indicated that aficamten, a cardiac myosin inhibitor, surpasses placebo in enhancing exercise capacity in patients with obstructive hypertrophic cardiomyopathy.

However, the new data left several questions unresolved, particularly regarding the comparison between aficamten and the already approved drug Camzyos. This event marked the first instance where Cytokinetics presented data from an exploratory analysis that enables a more straightforward comparison between the two drugs.

In the SEQUOIA-HCM trial, Cytokinetics primarily focused on exercise capacity as its endpoint, whereas Camzyos was evaluated based on a composite measure that assessed both exercise capacity and symptoms in its registrational study, which supported its FDA approval. Cytokinetics’ exploratory analysis showed how aficamten performed on the primary endpoint used to validate Camzyos.

According to the findings, 42% of patients on aficamten met the composite exercise capacity and symptom endpoint, compared to 14% of those on placebo. In contrast, the Camzyos trial indicated that 37% of patients on the study drug met the response criteria, versus 17% on placebo. The placebo-adjusted difference was more significant in the aficamten trial at 28%, compared to the 19% observed in the Camzyos study.

Additionally, Cytokinetics used the event to present results from pre-specified analyses of dosing and safety, including the incidence and effects of left ventricular ejection fraction (LVEF) falling below 50%. An LVEF of 50% to 70% signifies normal blood pumping from the heart’s left lower chamber.

In the aficamten trial, 3.5% of patients experienced LVEF below 50%, as determined by the core laboratory; however, there were no instances of worsening heart failure or treatment interruptions due to low LVEF. In comparison, 6% of patients on Camzyos had LVEF below 50%. LVEF returned to above the normal threshold after the interruption of Camzyos treatment.

Investor confidence in Cytokinetics surged following the top-line data release in December 2023, propelling the company’s share price upwards. This optimism persisted amid rumors of a potential Big Pharma acquisition. However, since then, the excitement and the share price have stabilized, with the stock trading steadily around $62 on Monday morning.

The European Society of Cardiology Heart Failure 2024 Congress provided Cytokinetics with an opportunity to demonstrate to cardiologists the growing enthusiasm surrounding aficamten. This comes ahead of its anticipated filing for FDA approval in the third quarter of the year. The event highlighted the potential of aficamten to not only match but possibly exceed the performance of Camzyos, setting the stage for a competitive battle in the heart disease treatment market.