Cancer drug developer Curis now has the FDA’s blessing to resume one of two clinical trials that were halted in the spring after a patient died. Curis said Thursday that the FDA revoked the partial clinical hold in an early-stage lymphoma study after the company came up with a plan to deal with a potentially fatal complication.
The status remains unchanged so far for a separate partial hold on a study testing the same Curis drug, emavusertib, in leukemia. The reported death occurred in this Phase 1/2a study, prompting the FDA to halt the trial on April 4. At the time, Lexington, Mass.-based Curis also voluntarily halted a Phase 1/2 study testing the drug in lymphoma as a precaution. The following week, the FDA placed a partial hold on that trial as well. Both partial holds allow currently enrolled patients to continue receiving the experimental drug, but prohibit the enrollment of new patients.
Kuris said in April that the patient who died had a dose-limiting side effect called rhabdomyolysis. This complication is characterized by the death of muscle tissue, which releases muscle fibers and other substances into the blood that damage organs such as the heart and kidneys. Rhabdomyolysis is a known complication of the drug Curis, which is a small molecule designed to block IRAK4, a protein that is part of a pathway that is often dysregulated in cancer patients.
In its announcement of lifting the partial hold on the lymphoma study, Curis did not disclose any additional details about the death of the patient in the leukemia study. But the biotech said that after reviewing a comprehensive data package provided by the company, the FDA agreed with Curis’ strategy to identify and manage rhabdomyolysis in the lymphoma study, which was designed to test a dose of 300 mg emavusertib twice daily. Curis said that as part of its agreement with the FDA, the company will also enroll at least nine additional patients at the 200 mg dose level.
Curis is working with clinical trial sites to resume enrolling new lymphoma patients in the third quarter, CEO James Dentzer said in a prepared statement. The company now expects to have clinical data from this study in 2023.
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