FDA partially halts leukemia studies of Gilead cancer drug

2023-08-21

并购免疫疗法引进/卖出

Dive Brief:

The Food and Drug Administration has told Gilead Sciences to suspend patient enrollment in clinical trials of magrolimab in acute myeloid leukemia, the company said Monday, in another setback for an experimental drug the company acquired via a $5 billion buyout three years ago.

Without detailing the reasons for the partial clinical hold, Gilead said it is discussing next steps with the FDA and other regulators to resolve the hold. Patients already taking magrolimab as part of ongoing AML trials can continue to receive it, and the hold doesn’t affect any trials in solid tumors.

The FDA action is another setback for magrolimab’s drug class, called CD47 inhibitors CD47 inhibitors, which has seen Bristol Myers Squibb and Surface Oncology cancel projects. Earlier this month, a small drug developer called ALX Oncology terminated trials of its CD47 drug in AML and myelodysplastic syndrome, the latter a condition in which magrolimab failed a study in July.

Dive Insight:

After the success of cancer immunotherapies like Keytruda and Opdivo, drugmakers went on a hunt to find new ways to defeat cancer by turning the immune system onto tumor cells. One such pathway was CD47, a cell protein that sends away immune cells called macrophages, the so-called “don’t-eat-me” signal.

Big pharma paid handsomely for rights to CD47 drugs, including Gilead’s takeout of Forty Seven, Pfizer’s $2.3 billion acquisition of Trillium; AbbVie’s licensing deal for I-Mab I-Mab’s CD47; and Boehringer Ingelheim’s deal to license a CD47 from OSE Immunotherapeutics.

Like CD47 projects that were canceled, magrolimab has had a bumpy road in testing so far. Trials in both AML and myelodysplastic syndrome were put on clinical hold in early 2022, but were allowed to proceed a few months later.

The hold is also a blow for Gilead’s strategy to build an oncology business beyond the CAR-T drugs it acquired with Kite Pharma and breast cancer drug Trodelvy, which came via the $21 billion buyout of Immunomedics.

Combined, its three marketed cancer drugs are on track to exceed $2 billion in sales this year, but they’re overshadowed by Gilead’s antivirals business, which between HIV, hepatitis and COVID drugs racked up more than $11 billion in sales in the first six months of 2023.

Gilead’s efforts to develop an oncology business began more than a decade ago when it bought out Calistoga Pharmaceuticals for $375 million, which gave it a blood cancer drug called Zydelig that has largely disappeared from use. A research deal with Arcus Biosciences targeting another controversial cancer pathway called TIGIT hasn’t made much progress, and a collaboration with European biotech Galapagos has run into trouble.

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