BeOne Medicines has shared encouraging topline outcomes from its Phase I/II trial, BGB-11417-201, evaluating the next-generation investigational BCL2 inhibitor, sonrotoclax, in adults with relapsed/refractory mantle cell lymphoma (r/r MCL).
These patients had previously received a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 treatment.
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The open-label, global, single-arm, multicentre trial included 125 adult subjects with this condition.
During the initial part of the study, 22 subjects were administered daily doses of sonrotoclax, either 160mg or 320mg, to evaluate the tolerability and safety. This part also aimed to determine the optimal dose for subsequent stages of the trial.
In the second part, 103 subjects received the established daily dose of 320mg of sonrotoclax, following a dose-escalation period, to further assess the safety and efficacy.
The primary endpoint of overall response rate (ORR), as evaluated by an independent review committee (IRC), was achieved, indicating that the therapy induced significant responses in those who had undergone extensive prior treatments.
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By GlobalDataThe study also yielded positive results in various secondary efficacy endpoints, such as the duration of response (DOR), progression-free survival (PFS), and complete response (CR) rate.
Sonrotoclax’s safety profile was said to have been tolerated well, with manageable toxicities reported.
BeOne Medicines R&D global head Lai Wang said: “For people with relapsed or refractory mantle cell lymphoma, the disease is aggressive, the treatment landscape fragmented, and the outcomes unacceptably poor. 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.”
BeOne Medicines is preparing for submission of these findings to the US Food and Drug Administration (FDA) and other international regulatory authorities to seek approval for sonrotoclax in the treatment of r/r MCL.
New drug applications have been accepted and are currently being reviewed by the China National Medical Products Administration’s Center for Drug Evaluation, with the potential for accelerated approval for r/r MCL and r/r CLL/SLL treatments.
The confirmatory Phase III CELESTIAL-RR MCL trial is already in progress, with the first subject enrolled in 2025.
