FDA Partially Pauses Cancer Drug Trial After Patient Death

MacroGenics reports four safety events, including one fatality, in phase 2 study of experimental therapy lorigerlimab.

Published on Feb. 25, 2026

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The FDA has placed a partial clinical hold on a cancer drug trial conducted by MacroGenics following four safety events, including one death. 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, one case of myocarditis, and one case of neutropenia and concurrent septic shock that led to a patient's death.

Why it matters

The partial clinical hold on the lorigerlimab trial highlights the importance of rigorous safety monitoring in drug development, especially for experimental cancer therapies. The FDA's action aims to protect patient wellbeing while the company investigates the safety concerns before potentially resuming the study.

The details

According to MacroGenics, a total of 41 patients have received doses of lorigerlimab every three weeks in the phase 2 study. The four safety events that prompted the partial clinical hold include two cases of thrombocytopenia (low platelet count), one case of myocarditis (heart inflammation), and one case of neutropenia (low white blood cell count) with concurrent septic shock that resulted in a patient's death.

  • On February 25, 2026, the FDA placed a partial clinical hold on MacroGenics' phase 2 trial of lorigerlimab.

The players

MacroGenics

A biopharmaceutical company based in Rockville, Maryland that is developing the experimental cancer therapy lorigerlimab.

Eric Risser

The president and CEO of MacroGenics.

FDA

The United States Food and Drug Administration, the federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

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What they’re saying

“At MacroGenics, our top priority is patient safety. 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.”

— Eric Risser, President and CEO, MacroGenics (MacroGenics)

What’s next

MacroGenics stated it is fully committed to working with the FDA to resolve the partial clinical hold on the lorigerlimab trial as soon as possible in order to resume enrollment in the study.

The takeaway

This case highlights the importance of robust safety monitoring and the FDA's role in protecting patients during clinical trials of experimental cancer therapies. The partial clinical hold on the lorigerlimab study demonstrates the agency's commitment to pausing trials when safety concerns arise, even if it means delaying potential new treatment options.