The FDA has placed a partial clinical hold on a cancer drug trial following four safety events, including one death, according to a Feb. 25 announcement from MacroGenics.
The partial hold pauses enrollment for MacroGenics’ phase 2 study on lorigerlimab, an experimental therapy for gynecologic cancers. The safety events include two cases of thrombocytopenia, which is low platelet count, and one case of myocarditis, or inflammation of the heart.
A fourth patient experienced neutropenia — or low levels of neutrophils, a type of white blood cell — and concurrent septic shock, which led to death, according to MacroGenics.
To date, 41 patients have received lorigerlimab doses every three weeks, the Rockville, Md.-based drugmaker said.
“At MacroGenics, our top priority is patient safety,” Eric Risser, president and CEO, said in a news release. “MacroGenics is fully committed to working closely with the FDA to resolve the partial clinical hold, and we intend to resume study enrollment as soon as possible.”
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