A phase 1/2 trial of BeOne Medicines’ sonrotoclax has hit its primary endpoint, furthering the biotech’s plans to launch the first BCL2 inhibitor for use in mantle cell lymphoma (MCL).
The single-arm study enrolled 125 adults with relapsed or refractory MCL. Participants had previously tried anti-CD20 therapy and a BTK inhibitor.
The study met its overall response rate primary endpoint and, in BeOne’s words, “showed promising results across several secondary efficacy endpoints, including complete response rate, duration of response and progression-free survival,” according to an Aug. 29 release.
BeOne is yet to share data from the trial but is confident enough in the results to start preparing to share its findings with the FDA and other global regulatory authorities.
An approval for the candidate would establish BeOne in an indication that is free from competition from the leading in-class rival.
Sonrotoclax hits the same target as AbbVie’s Venclexta. Pharmacyclics, part of AbbVie, ran a phase 3 trial to test Venclexta in combination with the BTK inhibitor Imbruvica in MCL. The regimen improved progression-free survival but never came to market. AbbVie and its partner Johnson & Johnson voluntarily withdrew Imbruvica in previously treated MCL in 2023.
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Having designed a BCL2 inhibitor that it claims is 14-fold more potent than Venclexta, BeOne identified the MCL market as one of the opportunities open to its drug candidate. Chinese authorities are already reviewing a filing for approval of sonrotoclax in relapsed or refractory MCL.
Sonrotoclax is also being reviewed in China as a treatment for chronic lymphocytic leukemia and small lymphocytic lymphoma.
Meanwhile, BeOne is testing the BCL2 inhibitor as a monotherapy and in combination with molecules including zanubrutinib and BGB-16673 in other blood cancers, reflecting its belief that it has unlocked multiple markets by trying to improve on Venclexta’s ramp-up and pharmacokinetics.
