Gilead Abruptly Halts Phase 3 Leukemia Trial Following Disappointing Data

Another failure has befallen the immuno-oncology wager that Gilead Sciences placed for $4.9 billion. After doing an ad hoc review of a phase 3 leukemia trial, the Big Biotech came to the conclusion that the anti-CD47 antibody was unlikely to boost patients’ chances of surviving the disease.

Since Gilead acquired Forty Seven in order to add it to its portfolio, the candidate known as magrolimab has been experiencing a number of difficulties. In only the past couple of months, Gilead has halted a phase 3 study in myelodysplastic syndromes (MDS) due to unimpressive interim effectiveness data and put a partial medical pause on late-stage trials in acute myeloid leukemia (AML). Both of these decisions were made in response to underwhelming data collected throughout the trial. 

At this time, Gilead has decided to completely halt one of its phase 3 AML investigations. In the ENHANCE-2 clinical study, individuals with AML who possessed genetic abnormalities – TP53 mutations, which are linked with treatment resistance – were given magrolimab. Gilead came to the conclusion that their medication candidate combined with azacitidine is not expected to increase survival rates above those offered by the standard of treatment after doing an ad hoc study and having the findings reviewed by a separate unbiased data monitoring committee.

Because of this decision, two out of Gilead’s three attempts to bring magrolimab to the market for the treatment of AML and MDS have been unsuccessful in rapid succession. The use of magrolimab as a primary therapy for ineffective AML is being investigated in its third try. Gilead stopped accepting new participants in the experiment one month ago, but work is still being done despite the limitations imposed by the temporary hold. 

In spite of the fact that Gilead is running out of chances of validating magrolimab in AML, the company has made the choice to commit to a comprehensive development program, which indicates that it still has other options. The biotechnology company is evaluating the anti-CD47 antibody in solid tumors in addition to investigating it in conjunction with other therapies for multiple myeloma and diffuse large B-cell lymphoma, even if this study is still in the phase 2 testing phase. 

The partial clinical hold that the FDA put on magrolimab in other contexts a month ago was lifted for the trials that were conducted on patients with solid tumors. In midphase clinical investigations, Gilead is testing the candidate in patients who have triple-negative breast cancer, colorectal cancer, head and neck cell issues as well as other solid tumors.

In other, more positive news for Gilead, a federal judge in California granted initial consent to a proposed agreement between the firm and the direct buyers of its HIV medications, Truvada and Atripla. In particular, the corporation committed to financing a settlement amounting to over $246 million, intended for the entities that procured these medications between February 2018 and November 2022, as indicated in the order.

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