Announcement • Aug 05

Nurix Therapeutics Enrolls First Patient In Registrational Phase 3 DAYBreak CLL-306 Trial Of Bexobrutideg In Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma

Nurix Therapeutics announced that the first patient has been enrolled in the global Phase 3 DAYBreak CLL-306 study (NCT07516093) evaluating bexobrutideg, a potential best-in-class targeted protein degrader of Bruton’s tyrosine kinase (BTK), in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously received a covalent BTK inhibitor. The global study is being conducted under the collaboration between Nurix and Roche and marks the first Phase 3 trial for bexobrutideg. The registrational study is designed to demonstrate the superiority of bexobrutideg versus the non-covalent BTK inhibitor pirtobrutinib, the current standard of care in this treatment setting for patients whose disease has progressed following prior covalent BTK inhibitor therapy. The randomized Phase 3 trial is expected to enroll approximately 620 patients with relapsed or refractory CLL/SLL who have previously progressed on a covalent BTK inhibitor. Patients will be randomized 1:1 to receive either bexobrutideg 600 mg orally once per day or pirtobrutinib. The dual primary endpoints are objective response rate (ORR) and progression free survival (PFS), as assessed by an independent review committee. The study is designed to evaluate the potential superiority of bexobrutideg relative to pirtobrutinib and support global regulatory submissions. Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant, highly selective small-molecule degrader of Bruton’s tyrosine kinase (BTK) being developed by Nurix and Roche as a potential best-in-class therapy across oncology, immunology and neurology. Bexobrutideg is currently being evaluated in a broad clinical development program in patients with chronic lymphocytic leukemia (CLL) including the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study in patients with relapsed or refractory CLL, the DAYBreak CLL-306 clinical trial (NCT07516093), a randomized Phase 3 trial comparing bexobrutideg to pirtobrutinib in patients with relapsed or refractory CLL, and the NX-5948-301 Phase 1a or 1b clinical trial (NCT05131022) in patients with relapsed or refractory B-cell malignancies. Nurix’s plans also include the NX-5948-203 Phase 1 or 2 clinical trial (NCT07520006), assessing the combination of bexobrutideg with venetoclax with or without an anti-CD20 antibody in patients with relapsed or refractory CLL and treatment naïve CLL. A new tablet formulation of bexobrutideg is being evaluated in a first-in-human single-ascending-dose and multiple-ascending-dose study in healthy volunteers (NCT06717269) to support future development in immunology and neurology indications. Additional information about these clinical trials can be found at clinicaltrials.gov.

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Nurix Therapeutics Enrolls First Patient In Registrational Phase 3 DAYBreak CLL-306 Trial Of Bexobrutideg In Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma

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