Results from phase III HEART-FID trial of Injectafer in iron deficiency plus HFrEF fail to meet endpoint and presented at ESC 2023 and published in NEJM.- American Regent/Daiichi Sankyo
American Regent/Daiichi Sankyo announced results from the phase III HEART-FID trial of Injectafer (ferric carboxymaltose injection) for the treatment of iron deficiency in adult heart failure patients with reduced ejection fraction (HFrEF).
While there was a numerical improvement in the hierarchical composite endpoint, the trial did not meet statistical significance on the primary endpoint, which was a hierarchical composite of death and heart failure hospitalization at 12 months and change from baseline to 6 months in the 6-minute walk test distance. The HEART-FID trial was designed as a single pivotal study instead of two based upon a special protocol assessment with the FDA. As a result, the study included a significance level for the final analysis of 0.0099 for the primary endpoint preserving the overall significance at 0.01. The safety profile of ferric carboxymaltose injection was consistent with previous reports with no new safety concerns identified.
Results from the HEART-FID study showed that for adult heart failure patients with stable chronic HFrEF who received intravenous ferric carboxymaltose, there were numerically fewer deaths and hospitalizations for heart failure through 12 months and a modest benefit in the six-minute walking distance (6-MWD) at 6 months compared to placebo. At 12 months, death occurred for 131 patients (8.6%) in the ferric carboxymaltose group and 158 patients (10.3%) in the placebo group; there were 297 and 332 total hospitalizations for heart failure, respectively; and the mean change in 6-minute walk distance at 6 months was 8 +/- 60 meters and 4 +/- 59 meters, respectively. The p-value for the primary composite endpoint was p=0.019. Although there was a numerical improvement in the hierarchical composite endpoint, the study did not meet the pre-specified significance level of 0.0099.
Data from the HEART-FID study (NCT03037931) were presented in a late-breaking research Hot Line session at the European Society of Cardiology Congress 2023. The results were simultaneously published in the New England Journal of Medicine.
See: "Ferric Carboxymaltose in Heart Failure with Iron Deficiency" Robert J. Mentz et al. NEJM August 26, 2023 DOI: 10.1056/NEJMoa2304968
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