Cell therapy reduces cardiac death, has no effect on nonfatal heart failure events
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A randomized phase 3 trial designed to evaluate rexlemestrocel-L for patients with advanced chronic heart failure failed to achieve its primary endpoint, according to topline data released by the agent’s manufacturer.
The investigational cell therapy reduced incidence of stroke and heart attacks by 60%, and also resulted in a 60% decrease in death due to cardiac causes among patients treated in earlier stages in the progressive disease process. However, researchers reported no reduction in recurrent nonfatal decompensated heart failure events, which served as the DREAM-HF trial’s primary endpoint.
Rexlemestrocel-L (Revascor; Mesoblast) is an allogeneic mesenchymal precursor cell therapy under development for patients with moderate to advanced or end-stage chronic heart failure. The therapy is administered via transendocardial injection by catheter.
“The trial results show that rexlemestrocel-L significantly reduces cardiovascular mortality when used early in [patients with heart failure] at risk [for] disease progression and provides durable protection from heart attacks or strokes in these vulnerable patients,” trial investigator Emerson Perin, MD, PhD, FACC, director of the Center for Clinical Research, medical director of Texas Heart Institute and clinical professor at Baylor College of Medicine, said in a Mesoblast-issued press release. “New therapies have not materially reduced the high death rates from cardiovascular disease, which is why these data have the potential to change the treatment paradigm for patients with advanced chronic heart failure.”
The DREAM-HF study included 537 patients with advanced heart failure.
Researchers assigned patients to a sham procedure or a single dose of rexlemestrocel-L injected directly into the myocardium in addition to maximal therapies.
Mean follow-up was 30 months.
Despite failure to achieve the trial’s primary endpoint, the results showed a significant 60% reduction in incidence of nonfatal ischemic major adverse cardiac events — including heart attack or stroke — in the experimental group compared with the control group (P = .002).
Researchers also reported a 60% reduction (P = .037) in death due to all cardiac causes among the subgroup of 206 patients with earlier-stage disease, defined as New York Heart Association (NYHA) class II.
Patients with NYHA class II heart failure also showed a significant 55% decrease in the composite endpoint of prespecified cardiovascular death or ischemic major adverse cardiac events compared with patients in the control group (P = .009).
“We expect the mortality benefit observed in this seminal phase 3 trial will support a potential path for approval of rexlemestrocel-L in patients with advanced chronic heart failure,” Fred Grossman, DO, FAPA, chief medical officer for Mesoblast, said in the release. “We are planning to meet and discuss potential pathways to approval based on mortality reduction with the [FDA].”
The FDA previously granted orphan drug designation to rexlemestrocel-L for the prevention of postimplantation mucosal bleeding among patients with end-stage chronic heart failure who require a left ventricular assist device.
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