Nuvectis Reports Positive Data from NXP200 Phase 1b Study Demonstrating Durable Responses, Including Complete Responses, in BRAF V600-mutated Recurrent or Progressive Gliomas
Key Highlights
- ➤High-grade glioma ORR reached 40.0%, including three complete responses
- ➤Low-grade glioma ORR reached 42.9%, including one complete response
- ➤Deep responses exceeded 80% tumor reduction in 87.5% of high-grade responders
- ➤NXP200 produced responses despite prior BRAF inhibitor treatment in two patients
- ➤12-month survival reached 95% in high-grade and 100% in low-grade cohorts
Expert Statements
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis
“We congratulate our partner Haisco on these robust results with NXP200. The rate and durability of the responses reported with single-agent NXP200 in patients with recurrent or progressive gliomas are very encouraging, given the depth of the observed responses, which include CRs and PRs with >80% tumor burden reduction, together with the ability to induce responses in patients previously treated with a BRAF inhibitor while maintaining a manageable safety profile. We are excited about the emerging clinical profile of NXP200, which demonstrates the potential of NXP200 to become a differentiated, best-in-class, second-generation, paradox-breaker BRAF inhibitor. We look forward to further updates from the ongoing Phase 1b program, including in additional tumor types, and we remain on track to submit a U.S. IND for NXP200 by the end of this year.”
* Single-agent NXP200 was administered to 27 patients with recurrent or progressive gliomas (20 with high-grade and 7 with low-grade). * The objective response rate (ORR) based on Response Assessment in Neuro-Oncology criteria (RANO) 2.0 was 40.0% (8/20) in high-grade glioma, including 3 Complete Responses (CRs), and 42.9% (3/7) in low-grade glioma, including 1 CR. * Deep responses (>80% tumor burden reduction) were reported in 87.5% (7/8) of responders with high-grade glioma and 66.7% (2/3) of responders with low-grade glioma. * Of the three patients previously treated with a BRAF inhibitor, two achieved a Partial Response (PR) and one had Stable Disease (SD). * NXP200 demonstrated a manageable safety profile. Fort Lee, NJ, Oct. 26, 2026 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, today provided highlights from the oral presentation of positive, expanded data from the Phase 1b study for NXP200, a second-generation, paradox-breaker BRAF inhibitor, in patients with recurrent or progressive BRAF V600-mutated gliomas at the 2026 European Society for Medical Oncology (ESMO) Congress taking place in Madrid, Spain.
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