Nurix Enrolls First Patient in Phase 3 CLL Trial

Nurix Therapeutics announced the enrollment of the first patient in the global Phase 3 DAYBreak CLL-306 study (NCT07516093) evaluating bexobrutideg, a targeted protein degrader of Bruton's tyrosine kinase (BTK), in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received a covalent BTK inhibitor. The registrational trial, conducted under the Nurix-Roche collaboration, is designed to demonstrate superiority of bexobrutideg versus pirtobrutinib, the current standard of care in this setting. Approximately 620 patients will be randomized 1:1 to receive bexobrutideg 600 mg orally once daily or pirtobrutinib, with dual primary endpoints of objective response rate and progression-free survival. This marks the first Phase 3 trial for bexobrutideg and a key milestone in the program. Bexobrutideg is also being evaluated in earlier-phase trials, including a pivotal Phase 2 study in relapsed/refractory CLL and a Phase 1a/1b study in B-cell malignancies. Nurix is developing bexobrutideg in collaboration with Roche, and also has collaborations with Gilead, Sanofi, and Pfizer for other pipeline assets.