Nurix Therapeutics, Inc. (NASDAQ: NRIX) has presented updated clinical data for its investigational drug, NX-5948, at the European Hematology Association Congress. The oral presentation detailed the results of an ongoing phase 1a/b clinical trial in adults with relapsed or refractory B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL).
The study involved 79 patients, with 31 of them having relapsed or refractory CLL. Among the efficacy evaluable patients with CLL, NX-5948 treatment resulted in a robust objective response rate (ORR) of 69.2% across all doses tested. Notably, responses were observed as early as the first scan (8 weeks), and many patients experienced deepening of their response with longer time on treatment. This is particularly significant as the cohort of CLL patients was heavily pretreated, having received a median of four prior lines of therapy, including prior covalent BTK inhibitors (96.8%), prior BCL2 inhibitors (90.3%), and prior non-covalent BTK inhibitors (25.8%).
Furthermore, the study presented compelling case reports of individual patients. One patient with CLL and central nervous system (CNS) involvement, who had undergone three prior therapies, including treatment with a BTK inhibitor, exhibited a deepening response approaching complete response criteria by 36 weeks after receiving daily treatment with NX-5948. Another patient, who had received eleven prior lines of therapy, including all available BTK inhibitors, achieved a response by week 8 with NX-5948 treatment, which deepened over time and was ongoing with over 6 months of follow-up.
The safety profile of NX-5948 was also highlighted, with the drug being well-tolerated across all doses evaluated. The most common treatment emergent adverse events were purpura/contusion, thrombocytopenia, and neutropenia.
Dr. Kim Linton, a senior lecturer at the University of Manchester and an investigator on the clinical trial, expressed optimism about the potential of NX-5948, particularly in addressing emerging patterns of resistance to currently available targeted therapies for relapsed CLL.
Nurix Therapeutics intends to advance NX-5948 into pivotal trial(s) in 2025 based on the growing body of positive clinical data and the drug's demonstrated activity. The company also plans to expand the phase 1b portion of the trial across a range of CLL subpopulations in preparation for the initiation of pivotal, registration-directed clinical evaluation in 2025.
Arthur T. Sands, M.D., Ph.D., President, and Chief Executive Officer of Nurix, emphasized the potential of NX-5948 to provide an important treatment option for patients with CLL and NHL, stating the company's intention to move rapidly forward with the goal of initiating pivotal trials with NX-5948 in 2025.
Today the company's shares have moved 1.0% to a price of $15.33. For the full picture, make sure to review Nurix Therapeutics's 8-K report.
