The registrational DAYBreak CLL-306 study will compare the BTK degrader against pirtobrutinib in about 620 relapsed or refractory CLL/SLL patients previously treated with a covalent BTK inhibitor.
Nurix Therapeutics said the first patient has been enrolled in the global Phase 3 DAYBreak CLL-306 study of bexobrutideg in relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after prior treatment with a covalent BTK inhibitor. The trial, conducted under Nurix’s collaboration with Roche, is the first Phase 3 study for bexobrutideg and is designed to test whether the targeted protein degrader of Bruton’s tyrosine kinase can outperform pirtobrutinib, the current standard of care in this setting. The randomized registrational study is expected to enroll about 620 patients, who will be assigned 1:1 to receive either bexobrutideg 600 mg orally once daily or pirtobrutinib, with objective response rate and progression-free survival as dual primary endpoints assessed by an independent review committee. Nurix said the study is intended to support global regulatory submissions. Company executives said the program is aimed at showing that targeted protein degradation (removing a disease-driving protein) can deliver superior outcomes versus non-covalent BTK inhibition in patients with significant unmet medical needs. Beyond CLL, Nurix and Roche are also advancing bexobrutideg across oncology, immunology and neurology, while the company continues to develop a wider pipeline of degrader-based medicines and degrader antibody conjugates (DACs) under both partnered and wholly owned programs.