Nuvectis Pharma, Inc. NVCT stock is trading lower after the company reported data from the Phase 1b study evaluating NXP800 in patients with platinum-resistant ARID1a-mutated ovarian cancer.
Three dosing regimens have been evaluated 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 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 Officer of Nuvectis, said, “However, it is clear that we need to increase the dose intensity to drive more efficacy in the next set of patients. We are already enrolling patients into a cohort of up to 10-12 additional patients utilizing a regimen of 75 mg/day on an intermittent dosing schedule, which is expected to be the last cohort in this Phase 1b study. We expect to provide additional clinical data from the Phase 1b study in the second quarter of 2025.”
The NXP800 development program for this disease was granted FDA Fast Track Designation, and NXP800 was granted FDA Orphan Drug Designation for ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers.
Price Action: NVCT stock is down 43.20% at $6.05 at last check Thursday.
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