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FDA places partial clinical hold on three Gilead phase 3 trials for MDS and AML treatments

The company confirmed that six other phase 2 trials would go ahead as previously planned

Gilead

Gilead Sciences has shared that the US Food and Drug Administration (FDA) has placed a partial clinical hold on three phase 3 trials assessing the combination of magrolimab plus azacitidine used for patients with myelodysplastic syndrome (MDS), acute myeloid leukaemia (AML) and AML patients unable to receive intensive chemotherapy.

The partial hold was also applied to earlier stage studies for MDS and myeloid malignancies. The company confirmed that six other phase 2 trials would go ahead as previously planned and also stated that tests evaluating magolimab in isolation, without azacitidine or in combination with other drugs, remain unaffected by the latest decision.

Gilead said that the partial hold on the clinical trials was due to the FDA’s decision to act in the interest of patient safety, with concerns over an apparent imbalance in reported suspected unexpected serious adverse reactions (SUSARs) between branches of the study.

"The safety and well-being of people enrolled in our studies is our top priority. We will share more information with the medical and patient community as soon as we can,” said Merdad Parsey, chief medical officer at Gilead Sciences.

Despite the company being unable to identify any specific adverse reactions or negative safety markers, it has been decided that the partial clinical hold will be implemented by Gilead companywide regarding all ongoing combination studies of magrolimab and azacitidine.

For participants already enrolled in the clinical studies, close monitoring according to study protocol will be carried out, with the participants continuing to receive magrolimab and azacitidine, or a placebo.

Gilead is in the process of gathering additional data analyses in order to address the issues raised by the FDA, alongside company efforts to notify clinical investigatory teams and regulatory authorities worldwide about the clinical hold.

Parsey continued: “We remain confident in the potential of magrolimab across a broad range of tumours, including the other, ongoing magrolimab studies. We are grateful to those participating in our studies, their families, and the investigators for their continued contributions to the clinical programme for magrolimab.”

Gilead is continuing to work with regulators, with the aim to decide the best course of action in removing the partial hold on the studies impacted.

Speaking on the company’s commitment to developing new MDS therapies, Parsey said: “Considering the high unmet need for new medicines in myelodysplastic syndrome and acute myeloid leukemia, we will work closely with regulatory authorities worldwide to continue the magrolimab development programme appropriately.”

Article by
Fleur Jeffries

27th January 2022

From: Regulatory

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