Two BCL-2 inhibitors feature in phase 3 starts

BeiGene's Brukinsa is one of this year's successes, with results from the head-to-head Alpine study versus AbbVie/J&J's Imbruvica in previously treated chronic lymphoblastic leukaemia, together with a first-line label brought by the Sequoia trial, helping it gain market share at the expense of Imbruvica and AstraZeneca's Calquence. BeiGene's next big bet comes with sonrotoclax, a BCL-2 inhibitor that is now entering its first phase 3 trial, in first-line CLL, and the group is again taking the bold step of challenging another established market leader, Roche/AbbVie's Venclexta. The study will evaluate sonrotoclax plus Brukinsa versus Venclexta and Gazyva, with PFS as the primary endpoint. Sonrotoclax is already being evaluated as a monotherapy in two single-arm phase 2 studies in the post-BTK inhibitor setting, where BeiGene is striving for early registrations in mantle cell lymphoma and Waldentröm's macroglobulinaemia. This is not the end of Venclexta's upcoming threats. In first-line CLL Ascentage Pharma's own BCL-2 inhibitor, lisaftoclax, will be starting its second global phase 3 study, which obtained the NMPA's greenlight last night. The upcoming trial will evaluate lisaftoclax plus Calquence versus immunochemotherapy. The removal of a BTK inhibitor lead-in is Ascentage's key differentiating feature in the growing BCL-2 space.

Recently disclosed projects newly into phase 3*

Note: *projects’ first phase 3 studies, as newly listed on the clinicaltrials.gov database between 3 and 13 October 2023.