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December 8, 2025BloodOpen Access

Zanubrutinib + obinutuzumab + sonrotoclax in patients with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (TN CLL/SLL): Initial results from an ongoing phase 1/1b study, BGB-11417-101

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Authors

MTMonica TaniGMGabriel ManSPSheel Patel

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Overview

Phase 1/1b trial shows 100% overall response rate in treatment-naive chronic lymphocytic leukemia, indicating effective combination therapy.

Key Points

  • Assess the safety and efficacy of zanubrutinib, obinutuzumab, and sonrotoclax in treatment-naive chronic lymphocytic leukemia.
  • Phase 1/1b dose-escalation study
  • Patients received zanubrutinib and obinutuzumab, with sonrotoclax introduced in Cycle 2
  • Endpoints included safety, overall response rate, and minimal residual disease status.
  • 100% overall response rate observed in efficacy-evaluable patients
  • 60% achieved complete response or complete response with incomplete marrow recovery
  • Median follow-up was 14.6 months with no progression-free survival events.

Cite This Study

Tani et al. (2025) studied this question.

synapsesocial.com/papers/69362f4e4fa91c937236d86fhttps://doi.org/10.1182/blood-2025-3890
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Frontline treatment of sonrotoclax (BGB-11417) and zanubrutinib for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) demonstrates high undetectable minimal residual disease (uMRD) rates with favorable tolerability: Updated data from BGB-11417-101, an ongoing phase 1/1b study2025 · 1 citations
  2. 2CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naïve (TN) CLL.2024 · 8 citations
  3. 3MRD-guided therapy of sonrotoclax (BGB-11417) + obinutuzumab (O) in patients with treatment-naive CLL: Initial results from an ongoing phase 1/1b study, BGB-11417-1012025 · 1 citations
  4. 4Trium study: Exploring MRD-guided triplet therapy with sonrotoclax, zanubrutinib, and CD20mab in Untreated Mantle Cell Lymphoma: A prospective, multicenter, Phase II Study2025 · 1 citations
  5. 5Effect of first-line treatment of CLL/SLL with the all-oral combination of sonrotoclax (sonro) and zanubrutinib (zanu) on minimal residual disease (uMRD) rates, including in patients with del(17p)/TP53.2026