Shares of BeOne Medicines AG DRC (NASDAQ:ONC) gained 4.4% on Friday after the biotech announced encouraging topline findings from its Phase 1/2 clinical trial of sonrotoclax in patients with relapsed or refractory mantle cell lymphoma (MCL).
The study, which included 125 adults who had previously been treated with both a Bruton’s tyrosine kinase inhibitor and anti-CD20 therapy, achieved its primary endpoint of overall response rate, as confirmed by an independent review committee.
BeOne highlighted that sonrotoclax — a next-generation investigational BCL2 inhibitor that the company considers potentially best-in-class — showed “clinically meaningful responses” in a heavily pretreated patient population. Secondary measures such as complete response rate, duration of response, and progression-free survival also produced favorable signals. Safety was described as “generally well-tolerated” with “manageable” side effects.
“These topline results for sonrotoclax underscore its potential to deliver meaningful and durable responses and offer the first BCL2 inhibitor for patients with R/R MCL, if approved,” said Lai Wang, PhD, Global Head of R&D at BeOne Medicines.
The company intends to file the data with the U.S. Food and Drug Administration as well as other regulatory agencies worldwide. In China, applications for accelerated approval of sonrotoclax are already under review for both R/R MCL and relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
A larger confirmatory Phase 3 trial, known as CELESTIAL-RR MCL, is currently in progress after enrolling its first patient earlier this year. Sonrotoclax has already received Orphan Drug Designation from the FDA for the treatment of mantle cell lymphoma.
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