Nuvectis Pharma CEO Says Increased Dose Intensity Needed To Drive More Efficacy From Ovarian Cancer Lead Drug

Core Viewpoint - Nuvectis Pharma, Inc. reported data from a Phase 1b study of NXP800 for treating platinum-resistant ARID1a-mutated ovarian cancer, leading to a significant decline in stock price. Group 1: Study Details - The Phase 1b study evaluated three dosing regimens in twelve patients, with four patients on a once-per-day schedule of either 75 mg or 50 mg [1] - Eight additional patients were treated with 50 mg/day on an intermittent schedule of five days on and two days off to reduce thrombocytopenia risk [2] - All patients had previously failed at least two lines of systemic chemotherapy, including one platinum-based regimen, with most also having failed bevacizumab treatment [2] Group 2: Efficacy and Safety - Among eleven efficacy-evaluable patients, antitumor activity was noted, with one unconfirmed partial response and six patients showing stable disease [3] - In the initial safety evaluation, three out of four patients experienced Grade 4 thrombocytopenia, while the intermittent dosing schedule resulted in a maximum of Grade 2 thrombocytopenia in one patient [3][4] - Common treatment-emergent adverse events included nausea, fatigue, vomiting, diarrhea, and constipation, primarily Grade 1-2 [4] Group 3: Future Plans and Designations - The CEO indicated a need to increase dose intensity for better efficacy, with plans to enroll 10-12 additional patients at 75 mg/day on an intermittent schedule [5] - The NXP800 program received FDA Fast Track Designation and Orphan Drug Designation for specific ovarian cancers [5] Group 4: Market Reaction - Following the report, NVCT stock fell by 43.20%, trading at $6.05 [6]