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Gilead’s CD47 Clinical Hold Expands As CEO O’Day Expresses ‘sense of Urgency’ in Getting Trials Back on Track

Elijah

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Gilead revealed that a partial clinical hold for its CD47 targeted cancer hopefulis larger than originally thought.

Last week, the California-based biotech shared that a handful of trials for magrolimab in combination with azacytidine had been placed on a partial clinical hold because of an “apparent imbalance” in adverse reactions seen in the study arms. The hold applied to five studies, ranging from early- to late-stage development for myelodysplastic syndrome (MDS), acute myeloid leukemia and myeloid malignancies, including the phase 3 Enhance trials.

As of the Jan. 25 announcement, six ongoing phase 2 trials were not subject to the hold, including two studies for diffuse large B-cell lymphoma and multiple myeloma.

But Gilead disclosed (PDF) in the fine print of the pharma giant’s fourth-quarter earnings presentation Tuesday that those two studies are indeed subject to the hold, bringing the total number of affected trials to seven. According to the slide presentation, the “FDA placed partial clinical holds on trials evaluating magrolimab in combination with azacitidine as well as the fully enrolled DLBCL and MM study.” These two studies were not combining magrolimab with azacytidine.

RELATED: Gilead’s $4.9B oncology bet hit with partial clinical hold, forcing pause of pivotal trials and raising doubts about CD47

Chief Medical Officer Merdad Parsey, during a Tuesday earnings conference call. referred to the changes as a “subsequent partial clinical hold” for the two studies. The troubles arose from a review of a preliminary dataset that suggested an apparent imbalance in suspected unexpected serious adverse reactions identified in the treatment groups in the phase 3 trial in high-risk MDS, according to Parsey.

Enrollment in the MM study had not really gotten underway yet, which Parsey believes may have been a consideration for the FDA. The DLBCL study, however, had been fully enrolled.

Patients already enrolled are clear to keep taking magrolimab, and Gilead is also maintaining a compassionate use program for the therapy.

Parsey also said that Gilead is abandoning a phase 1b single arm study in higher-risk MDS because of regulatory feedback. This trial “no longer has a viable path to submission,” he said. Data from the 1b will be released at an upcoming scientific meeting. Gilead will continue in the indication as part of the phase 3 Enhance trials.

The focus will continue to be on the much more advanced Enhance studies, which are for patients with MDS and two types of AML. Patients in Enhance “have a very high unmet need” and are typically quite sick, according to Parsey. Median survival for these cancers is one to three years on existing standard of care.

RELATED: Gilead taps brakes on $4.9B bet after rival’s failure

“I can tell you that we feel that these are temporary challenges right now, and we’re going to work through resolving it as quickly as possible,” Parsey said. “I don’t think these challenges really shake our confidence for the portfolio overall, and our overall strategy hasn’t changed.”

Later in the conference call, CEO Daniel O’Day and CFO Andrew Dickinson expressed confidence in Gilead’s overall oncology program in light of the clinical hold.

“We have obviously a lot of patients on magrolimab. They continue to be served by magrolimab. So we have a sense of urgency in working with the agency around this,” O’Day said.

To respond to the FDA request, Gilead is gathering safety information, which will be shared with the FDA and the data monitoring committee. Parsey and O’Day promised to share the outcome of the safety review as quickly as possible.

RELATED: Gilead’s COVID-19 antiviral Veklury blew past sales estimates in late 2021 as omicron surged, vaccinations lagged

“We have complete confidence in where we’re going, and we don’t expect to change our business development strategy as a result of any of the recent developments,” Dickinson said. “We’re incredibly pleased with what we’ve put together, and nothing that’s happened recently has changed that in any way.”

Magrolimab is an anti-CD47 antibody that Gilead acquired through the $4.9 billion takeover of Forty Seven.

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Article: fiercebiotech.com

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