The oral drug INCB123667 showed encouraging early results in patients with platinum-resistant ovarian cancer whose tumors overexpress cyclin E1, a protein linked to poor outcomes.
In a Phase 1 trial, 14 patients receiving a 100-mg daily dose achieved an overall response rate of 35.7%, with all responses being partial. The disease control rate was 71.4%, while median progression-free survival was 4.5 months and the median duration of response was 3.6 months. Responses were seen in patients with either CCNE1 gene amplification or cyclin E1 protein overexpression.
The treatment was generally manageable. Nearly all patients experienced side effects, with 35.6% having severe events. The most common side effects were nausea, constipation, and anemia, and no treatment-related deaths occurred.
Based on these results, the global Phase 3 MAESTRA-2 trial is comparing INCB123667 with standard chemotherapy in about 466 patients. If successful, the oral therapy could provide a more convenient alternative to intravenous chemotherapy and may later be combined with other targeted or immunotherapy treatments.