Curis gets FDA green light to restart lymphoma trial, though partial hold on leukemia study stays in place

The FDA has greenlighted Curis' phase 1/2 lymphoma trial, lifting a partial clinical hold on the study assessing emavusertib. Yet, a partial hold remains for the biotech’s leukemia trial evaluating the same drug.

The news spiked the Massachusetts biotech’s stock up 47.6%, from $1.05 per share at market close yesterday to $1.55 at market open. Since market open, however, the stock has dropped down to $1.29. 

On April 11, the FDA placed a partial hold on Curis’ TakeAim Lymphoma study so it could investigate the safety and efficacy of emavusertib—an IRAK4 kinase inhibitor—in patients with relapsed or refractory B-cell malignancies. In the dose-escalation study, Curis is assessing the drug as both a monotherapy and in combination with BTK inhibitor Imbruvica from Johnson & Johnson and Pharmacyclics.

The mandated pause came a week after the FDA slapped a separate partial clinical hold on the biotech’s TakeAim Leukemia phase 1/2 study. That hold came on the heels of an information request about the death of an acute myeloid leukemia (AML) patient who experienced rhabdomyolysis and other conditions. Rhabdomyolysis—the breakdown of skeletal muscle—is a known dose-limiting toxicity of emavusertib.

Though the partial hold on the leukemia study remains intact, the lymphoma hold was lifted after Curis and the FDA agreed on a strategy for rhabdomyolysis identification and management, as well as on the enrollment of at least nine more patients at the 200 mg dose level of emavusertib in combination with Imbruvica.

Curis is now working with its clinical sites to resume enrollment of new patients in the third quarter of this year, according to Curis President and CEO James Dentzer.

As for the leukemia study, Curis was evaluating escalating doses of emavusertib as a monotherapy and in combination with azacitidine or AbbVie-Genentech drug Venclexta. The clinical trial was enrolling patients with relapsed or refractory AML or high-risk myelodysplastic syndrome before the FDA got wind of the safety signal.    

Under the hold, Curis can continue giving doses of 300 mg or lower to patients who are benefiting from emavusertib but cannot enroll any new participants. Emavusertib received an FDA orphan drug tag in AML.