Nuvectis Pharma Reports Encouraging NXP800 Interim Data Supporting Ongoing Enrollment in Phase 1b Study in Patients with Platinum-Resistant ARID1a-Mutated Ovarian Cancer

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[{"type":"text","content":" NXP800 demonstrated single agent activity New dosing schedule successfully minimized thrombocytopenia Fort Lee, NJ, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today reported encouraging data from the Phase 1b study evaluating NXP800 in patients with platinum resistant ARID1a-mutated ovarian cancer. Platinum-resistant, ARID1a-mutated ovarian cancer is a serious condition that carries a poor prognosis with an estimated life expectancy of approximately one year from diagnosis. The NXP800 development program in this disease was granted Fast Track Designation by the U.S. Food and Drug Administration (“FDA”), and NXP800 was granted Orphan Drug Designation by the FDA for the treatment of ARID1a deficient ovarian, fallopian tube and primary peritoneal cancers. Phase 1B Update Three dosing regimens have been evaluated to date in twelve patients (four patients were treated on a once per day dosing schedule, two with 75 mg/day and two with 50 mg/day. Subsequently, eight additional patients were treated with 50 mg/day on an intermittent dosing schedule of five days on / two days off, a dosing schedule implemented to mitigate thrombocytopenia). All patients enrolled into the study failed at least two prior lines of systemic chemotherapy, including at least one prior platinum-based chemotherapy regimen, and most had also failed treatment with bevacizumab. In eleven efficacy-evaluable patients, antitumor activity was observed with best responses including one patient with an unconfirmed partial response and six patients with stable disease, including tumor shrinkage. The Phase 1b interim data reported earlier this year included four patients evaluable for safety, of which three experienced Grade 4 thrombocytopenia. Subsequently, in the eight patients treated with NXP800 using the intermittent dosing schedule (50 mg/day, 5 days on / 2 days off), the highest grade of thrombocytopenia observed was Grade 2 (one patient). Other than thrombocytopenia, the most common treatment emergent adverse events included nausea, fatigue, vomiting, diarrhea and constipation, the majority of which being Grade 1-2. Ron Bentsur, Chairman and Chief Executive Of...

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