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FDA places partial hold on Curis cancer drug after patient death in clinical trial

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A study evaluating a Curis drug in leukemia is now under a partial FDA clinical hold following the death of a patient who experienced a complication that is a known dose-limiting toxic effect of the experimental therapy, emavusertib.

That toxic effect is rhabdomyolysis, which is the death of muscle tissue and the release of muscle fibers and other substances into the blood, causing injury to the heart and kidneys. This organ damage can be fatal. Curis released no additional details about the patient death in the Phase 1/2a clinical trial, but the Lexington, Massachusetts-based biotech said the FDA asked for information about the safety and efficacy of the drug, including data about rhabdomyolysis. The agency also asked how the company is determining the recommended dose for emavusertib in the Phase 2 portion of the study.

Emavusertib is a small molecule designed to block interleukin-1 receptor-associated kinase 4 (IRAK4), a protein that’s part of a signaling pathway involved in some types of cancer and inflammatory diseases. The open-label Phase 1/2 clinical trial of the Curis drug is a dose-escalation study enrolling patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). The study is designed to evaluate three doses of emavusertib given to patients as a monotherapy or in combination with either venetoclax, which is a standard treatment for AML, or azacytidine, a standard MDS treatment.

The partial old means no new patients may be enrolled in the study. However, patients currently in the study who are benefiting from the therapy may continue to receive treatment with the drug at twice-daily doses of 300 mg or lower—300 mg is the middle of the three doses being evaluated in the study.

A separate Phase 1/2 study is evaluating emavusertib in patients with lymphomas. In late 2020, Curis reported preliminary data that showed tumor reductions in six of the seven non-Hodgkin’s lymphoma patients treated with the 300 mg dose. Those patients had previously received a median of four prior lines of cancer treatment. At the time, Curis recommended that the Phase 2 portion of the clinical trial test a dose of 300 mg twice daily. That dose balances durable anti-cancer activity and extended tolerability, the company said.

Curis said that even though the lymphoma clinical trial is unaffected by the partial hold on the drug in leukemia, the company has decided to pause enrollment until the leukemia study partial hold is resolved.

“We are committed to ensuring the safety of patients in our studies and to working collaboratively with the FDA to develop therapies that meaningfully improve and extend patients’ lives,” Curis CEO James Dentzer said in a prepared statement. “Given the clinical profile of emavusertib observed to date, we are hopeful that the study can be resumed soon, after appropriate review. We continue to be confident in the potential of emavusertib to address the high unmet need of patients with AML or MDS.”

Curis is one of several companies developing cancer drugs addressing IRAK4. Competitors include Emmaus Life Sciences, Kurome Therapeutics, Kymera Therapeutics, and Rigel Pharmaceuticals. Curis has one FDA-approved medicine, the chemotherapy Erivedge. That product is marketed by Roche subsidiary Genentech under a licensing agreement that pays Curis royalties on the drug’s sales.

Curis’s stock price sank more than 33% Monday, closing at $1.62.

Photo by Flickr user K-State Research and Extension via a Creative Commons license

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