{"id":62317,"date":"2025-12-08T01:05:46","date_gmt":"2025-12-08T00:05:46","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/sonrotoclax-data-at-ash-2025-confirm-foundational-potential-across-b-cell-malignancies\/"},"modified":"2025-12-08T01:05:46","modified_gmt":"2025-12-08T00:05:46","slug":"sonrotoclax-data-at-ash-2025-confirm-foundational-potential-across-b-cell-malignancies","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/sonrotoclax-data-at-ash-2025-confirm-foundational-potential-across-b-cell-malignancies\/","title":{"rendered":"Sonrotoclax Data at ASH 2025 Confirm Foundational Potential Across B-cell Malignancies"},"content":{"rendered":"
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\nNovel BCL2 inhibitor sonrotoclax monotherapy demonstrates deep and durable clinical responses in R\/R MCL and R\/R CLL<\/i>\n<\/p>\n

\nSonrotoclax in combination with BRUKINSA demonstrated rapid MRD negativity in treatment-naive CLL, regardless of high-risk features<\/i>\n<\/p>\n

SAN CARLOS, Calif.–(BUSINESS WIRE)–$ONC<\/a> #BeOne<\/a>—BeOne Medicines Ltd.<\/a> (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today 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 (ASH) Annual Meeting & Exposition in Orlando, Florida. The five presentations highlight durable responses in heavily pretreated patients with relapsed\/refractory (R\/R) mantle cell lymphoma (MCL) and additional studies showing deep, rapid, and sustained undetectable minimal residual disease (uMRD) rates with sonrotoclax-based combinations in patients with treatment-naive chronic lymphocytic leukemia (CLL), highlighting the foundational potential of this medicine.\n<\/p>\n

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\n\u201cThe data we\u2019re presenting at ASH 2025 are redefining what physicians can expect from sonrotoclax as a next-generation BCL2 inhibitor,\u201d said Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne. \u201cOur data demonstrates that sonrotoclax has succeeded where others have failed, achieving deep and durable responses as a monotherapy in both R\/R CLL and MCL and notably fast kinetics as a combination therapy in treatment-na\u00efve CLL. With these results, we believe sonrotoclax will become a foundational medicine in B-cell malignancies, potentially transforming outcomes for patients worldwide.\u201d\n<\/p>\n

\nSonrotoclax could become the first BCL2 inhibitor indicated for R\/R MCL in the U.S., based on data showing an overall response rate (ORR) of 52.4%. (<\/i><\/b>Oral Presentation: 663<\/i><\/b><\/a>; December 7 from 5:00-5:15 PM EST)<\/i><\/b>\n<\/p>\n

\nIn this Phase 1\/2, global, multicenter, single-arm, open-label study (NCT05471843<\/a>), ORR by IRC was 52.4% (95% CI, 42.4-62.4) with a complete response (CR) rate of 15.5% (95% CI, 9.1-24.0) in patients with R\/R MCL post-treatment with anti-CD20 therapy and a BTK inhibitor treated with 320 mg of sonrotoclax (n=103). Notably, ORR by IRC benefit was consistent across patients with high-risk disease subtypes, including patients with TP53 <\/i>mutation, a key prognostic marker for MCL. In this patient group, ORR by IRC was 59.1% (95% CI, 36.3-79.3).\n<\/p>\n

\nAt a median study follow-up of 14.2 months (range, 0.3-24.9 months), the median duration of response (DOR) by IRC was 15.8 months (95% CI, 7.4 months-NE) and has yet to reach full maturity. The median time to response (TTR) was 1.9 months (range 1.6-6.5 months), and the median progression-free survival (PFS) was 6.5 months (95% CI: 4.0-10.4).\n<\/p>\n

\nTreatment with sonrotoclax monotherapy was generally well tolerated, and adverse events were manageable. The most common grade \u22653 treatment-emergent adverse events (TEAEs) in greater than 10% of patients were neutropenia (19.1%), infections (16.5%), and pneumonia (10.4%).\n<\/p>\n

\nThese data are under Priority Review by the U.S Food and Drug Administration<\/a> for potential accelerated approval.\n<\/p>\n

\n\u201cAchieving deep and durable responses in relapsed or refractory mantle cell lymphoma after BTK inhibitor therapy has been a long-standing challenge,\u201d said Michael Wang, M.D., Professor, Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, and presenting author of the study. \u201cIn this analysis, sonrotoclax monotherapy demonstrated meaningful and lasting responses in heavily pretreated patients, including those with high-risk disease. These findings are highly encouraging and suggest this next-generation BCL2 inhibitor could play a foundational role in improving outcomes for patients with limited treatment options.\u201d\n<\/p>\n

\nSonrotoclax combinations demonstrate fast responses with unmatched uMRD rates and notably better kinetics than current options<\/i><\/b>\n<\/p>\n

\nBGB-11417-101 (NCT04277637<\/a>) is an ongoing, phase 1\/1b, dose-escalation\/expansion study in patients with B-cell malignancies. Results presented at ASH showcase data from sonrotoclax combinations in patients with treatment-naive (TN) CLL\/SLL. Notable highlights include:\n<\/p>\n