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Visual abstract | Phase I/II BGB-11417-201 trial primary analysis: Sonrotoclax monotherapy in R/R MCL

By Dylan Barrett

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Feb 27, 2026

Learning objective: After reading this article, learners will be able to recall the efficacy and safety of sonrotoclax in patients with relapsed/refractory mantle cell lymphoma.


Do you know... Sonrotoclax is being assessed in the phase I/II BGB-11417-201 trial for the treatment of R/R MCL. Which mechanism of action best describes sonrotoclax?

Patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) with disease progression during or following treatment with Bruton’s tyrosine kinase inhibitors (BTKi) have limited treatment options.1 Sonrotoclax, a next-generation B-cell lymphoma-2 inhibitor (BCL-2i), has recently been granted breakthrough therapy designation and priority review by the U.S. Food and Drug Administration (FDA) for the treatment of R/R MCL.2,3 The ongoing, multicenter, single-arm, open-label, phase I/II BGB-11417-201 trial (NCT05471843) is assessing the efficacy and safety of sonrotoclax in 125 adult patients with R/R MCL previously treated with a BTKi.1

Results from the BGB-11417-201 trial were presented by Michael Wang during the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6–9, 2025, Orlando, US, and are summarized below.1

This educational resource is independently supported by BeOne Medicines. All content was developed by SES in collaboration with an expert steering committee. Funders were allowed no influence on the content of this resource.

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