BeOne Medicines Ltd. (NASDAQ:ONC) (formerly BeiGene) on Friday released topline results from a Phase 1/2 study (BGB-11417-201) of sonrotoclax, an investigational BCL2 inhibitor, in adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 therapy.
Mantle cell lymphoma (MCL) is a rare subtype of aggressive B-cell non-Hodgkin lymphoma (NHL)1 that develops in B-cells located in the mantle zone of the lymph nodes.
BeOne plans to present the full data at an upcoming medical meeting.
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The BGB-11417-201 Phase 1/2 study enrolled 125 adult patients.
In Part 1, 22 patients received daily treatment with either 160 mg or 320 mg of sonrotoclax to assess the safety and tolerability of sonrotoclax and identify the recommended dose for Part 2.
In Part 2, 103 patients were enrolled to receive the recommended daily dose of sonrotoclax (320 mg), following ramp-up, to assess the efficacy and safety of sonrotoclax.
The study met its primary endpoint of overall response rate (ORR) as assessed by an independent review committee (IRC), demonstrating that treatment with sonrotoclax elicited clinically meaningful responses in this heavily pretreated population.
The study also showed promising results across several secondary efficacy endpoints, including complete response (CR) rate, duration of response (DOR) and progression-free survival (PFS).
The safety profile was generally well-tolerated, and the toxicities were manageable.
BeOne plans to submit these data to the U.S. Food and Drug Administration (FDA) and other global regulatory bodies for the potential approval of sonrotoclax in R/R MCL.
New drug applications for sonrotoclax for R/R MCL and R/R CLL/SLL have also been accepted. They are under review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for potential accelerated approval.
The Phase 3 confirmatory CELESTIAL-RR MCL study is underway, with the first patient enrolled earlier this year. The U.S. FDA previously granted sonrotoclax Orphan Drug Designation for the treatment of patients with MCL.
Price Action: ONC stock is trading higher by 4.46% to $311.25 at last check Friday.
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