BeOne sees a first route to market for sonrotoclax

BeOne is to use the relatively rare blood cancer mantle cell lymphoma (MCL) as the route to first approval for its BCL2 inhibitor sonrotoclax. This follows a win toplined on Friday in sonrotoclax's phase 1/2 study in patients who had progressed on a BTK inhibitor like Imbruvica and anti-CD20 therapy, where BeOne said the project met a goal overall response rate. The company said it would use the data to file for US accelerated approval, subsequently relying on the phase 3 Celestial-RR MCL study to confirm this. The FDA is getting tough on confirmatory studies, and Imbruvica itself had its accelerated MCL nod rescinded after two phase 3 trials failed. Confirmatory trials now have to be substantially enrolled at the time of accelerated approval, and Celestial-RR MCL recruited its first patient earlier this year. The most important use for sonrotoclax, which BeOne hopes will challenge AbbVie's first-to-market BCL2 inhibitor Venclexta, remains chronic lymphoblastic leukaemia, where phase 3 studies are ongoing in first and second-line settings – both including Venclexta as head-to-head comparator. Venclexta isn't approved for mantle cell lymphoma, despite succeeding as part of an Imbruvica combo in the phase 3 Sympatico study back in 2023.

Key sonrotoclax trials in mantle cell lymphoma

Source: OncologyPipeline.