FDA Lifts Partial Hold on Trial Investigating Emavusertib in Lymphoma

The FDA has allowed the manufacturer of emavusertib to continue a phase 1/2 study investigating effects of the treatment in patients with lymphoma.

The Food and Drug Administration (FDA) has lifted their partial clinical trial hold on a study evaluating the inhibitor emavusertib in patients with lymphoma.

The goals of the phase 1/2 TakeAim Lymphoma study are to determine safety, maximum tolerated dose, signals of activity and the recommended dose of emavusertib for future studies, for patients with relapsed/refractory non-Hodgkin Lymphoma, Waldenström macroglobulinemia, lymphoplasmacytic lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma. according to a press release from the manufacturer of the drug, Curis. This current study will also focus on dose escalation and expansion in emavusertib alone and in combination with Imbruvica (ibrutinib).

"We are excited to announce that (the) FDA has completed its review of the TakeAim Lymphoma study and has lifted the partial clinical hold,” said James Dentzer, president and CEO of Curis, in the release. “We are working with our clinical sites to quickly resume enrollment of new patients in this study in the third quarter."

The partial hold, which was originally placed by the FDA in April of this year, was lifted after an agreement on Curis’ strategy to identify and manage patients who developed rhabdomyolysis (a medical condition which occurs when damaged muscle tissue release proteins and electrolytes into the blood and can result in permanent disability).

The agreement also states that researchers in the trial enroll at least nine additional patients receiving 200 milligrams of emavusertib in combination with Imbruvica.

In particular, emavusertib is an inhibitor that targets certain receptors often dysregulated in patients with cancer, according to the release. Emavusertib may target a long-form genetic expression present in approximately half of patients with acute myeloid leukemia and myelodysplastic syndrome.

Curis plans to release updated data from this study in 2023, according to the statement. The manufacturer is also discussing future clinical trial plans for emavusertib such as an optimal dose.

Of note, a separate partial hold was also placed on the TakeAim Leukemia study but has not been lifted at this time. The press release did not state reasons for either study’s partial hold.

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