BeOne Medicines (ONC) said Friday its phase 1/2 study of sonrotoclax met the primary endpoint of overall response rate in adult patients with relapsed/refractory mantle cell lymphoma, or MCL, after treatment with a Bruton's tyrosine kinase inhibitor and anti-CD20 therapy.
The study enrolled 125 patients and showed "clinically meaningful responses" in this rare B-cell lymphoma with high unmet need. Results also showed promising outcomes across secondary endpoints, including complete response rate, duration of response, and progression-free survival. The drug was generally well-tolerated and the toxicities were manageable, BeOne said.
The company said it will present full data at an upcoming medical meeting and plans to submit the results to the US Food and Drug Administration and other regulators for potential approval of sonrotoclax in relapsed/refractory MCL.
Shares of the company were up more than 3% in recent Friday premarket activity.