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FDA Lifts Partial Clinical Holds for Some Gilead Trials

This story has been updated from a previous version to clarify the timeline of the clinical holds and to correct which trials remain on hold.

NEW YORK – The US Food and Drug Administration lifted a partial clinical hold on Phase III trials of Gilead Sciences' magrolimab in combination with Bristol Myers Squibb's Vidaza (azacitidine) or Abbvie and Genentech's Venclexta (venetoclax) in acute myeloid leukemia and myelodysplastic syndrome following a review of safety data from each trial. However, two additional trials in B-cell lymphoma and multiple myeloma have been placed on hold. 

Five trials were put on hold in January due to a potential imbalance in suspected serious adverse events between study arms. Those include a Phase III trial in untreated myelodysplastic syndrome (ENHANCE), Phase III trials in acute myeloid leukemia (ENHANCE-3) and acute myeloid leukemia in TP53 mutant acute myeloid leukemia (ENHANCE-2), a Phase Ib study in hematological malignancies, and a Phase II trial in myeloid malignancies

The FDA's decision will allow studies put on hold in the US to resume enrollment, while Gilead said it plans to re-open corresponding studies outside the US that were on voluntary hold in coordination with regulatory authorities in those countries. Patients in the ENHANCE trial continued receiving treatment during the hold period, and Gilead said that the trial is on track for a readout in 2023. 

Gilead said that it is working with the FDA on remaining clinical holds affecting trials of magrolimab in diffuse large B cell lymphoma and multiple myeloma put in place on Feb. 1. The hold has also been lifted on a Phase I trial of Venclexta with Roche's Gazyva (obinutuzumab) and magrolimab in B-cell malignancies sponsored by the National Cancer Institute and Gilead's Phase II trial of magrolimab in multiple myeloma. That trial will enroll 153 participants with relapsed and refractory disease to receive magrolimab in combination with a number of other therapies. 

Gilead's clinical trials of magrolimab in solid tumors were not affected by the clinical hold. It did not provide an update on the status of the Phase II trial in myeloid malignancies or the Phase Ib trial in hematologic malignancies.