BeOne Medicines (ONC) announced new data on sonrotoclax, a next-generation investigational BCL2 inhibitor, demonstrating meaningful clinical benefit as monotherapy and in combination across B-cell malignancies. These data were featured at the 67th American Society of Hematology Annual Meeting & Exposition in Orlando, Florida. The five presentations highlight durable responses in heavily pretreated patients with relapsed/refractory mantle cell lymphoma and additional studies showing deep, rapid, and sustained undetectable minimal residual disease rates with sonrotoclax-based combinations in patients with treatment-naive chronic lymphocytic leukemia, highlighting the foundational potential of this medicine. In this Phase 1/2, global, multicenter, single-arm, open-label study, ORR by IRC was 52.4% with a complete response rate of 15.5% in patients with R/R MCL post-treatment with anti-CD20 therapy and a BTK inhibitor treated with 320 mg of sonrotoclax. Notably, ORR by IRC benefit was consistent across patients with high-risk disease subtypes, including patients with TP53 mutation, a key prognostic marker for MCL. In this patient group, ORR by IRC was 59.1%.
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