- Nurix Therapeutics reports positive Phase 1 clinical trial results for bexobrutideg (NX-5948) in CLL and WM patients.
- The drug achieved high overall response rates: 80.9% in CLL and 84.2% in WM patients.
- Bexobrutideg demonstrated a favorable safety profile with no new onset atrial fibrillation.
Nurix Therapeutics, Inc. (NRIX, Financial), a clinical-stage biopharmaceutical company, has announced positive data from their ongoing Phase 1a/b clinical trial of bexobrutideg (NX-5948) for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and Waldenström macroglobulinemia (WM). The trial reported an objective response rate of 80.9% in CLL patients and 84.2% in WM patients, signifying the potential of bexobrutideg as a breakthrough therapy for these conditions.
The clinical trial included heavily pretreated patients, with a median of four prior therapies for CLL and three for WM. Bexobrutideg showed durable responses, including a complete response in one CLL patient who has been on therapy for more than two years. The trial also included patients with poor prognostic features, such as TP53 mutations and CNS involvement, yet responses were observed irrespective of these challenging characteristics. For WM patients, responses were recorded regardless of MYD88 and CXCR4 mutation status.
In terms of safety, bexobrutideg was well-tolerated across all doses, with the most common adverse events being low-grade purpura/contusion, neutropenia, and thrombocytopenia. Notably, no new onset atrial fibrillation was observed, which is a common limitation associated with covalent BTK inhibitors, indicating bexobrutideg's advantage for patients intolerant to existing therapies.
Looking ahead, Nurix plans to initiate pivotal trials in 2025, positioning bexobrutideg as a promising treatment for patients who have exhausted standard treatment options. The company aims to further develop bexobrutideg into a differentiated treatment option for B-cell malignancies, leveraging its unique targeting approach and broad coverage of BTK mutations.
