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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*

ProjectMechanismCompanyTrialScheduled start
Avutometinib + defactinibDual RAF/MEK inhibitor + FAK inhibitorVerastem (ex Chugai (Roche))Ramp-301, 2L+ serous ovarian cancer vs physician’s choice15 Oct 2023
Bria-IMTSV-BR-1-GM immunotherapyBriaCell TherapeuticsBria-ABC, chemo combo +/- Zynyz in 2L breast cancer, vs physicians’ choiceOct 2023
FiclatuzumabAnti-HFG MAbLG Chem (Aveo)Fierce-HN in post-PD-(L)1 HPV-ve head & neck cancer, Erbitux combo vs ErbituxDec 2023
SonrotoclaxBCL-2 inhibitorBeiGene1L CLL, Brukinsa combo vs Venclexta + Gazyva1 Dec 2023