A Phase 2, Single-Arm Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Summary

This multicenter, single-arm, phase II study evaluates the efficacy and safety of INCB123667, an oral CDK2 inhibitor, in participants with platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with cyclin E1 overexpression. Preliminary data from the Phase 1 study INCB123667-101 demonstrated encouraging efficacy and an acceptable safety profile in a heavily pretreated platinum-resistant ovarian cancer population with tumor cyclin E1 overexpression, supporting the focus on this biomarker-defined population. Study INCB123667-203 includes participants with platinum-resistant ovarian cancer who have received 1 to 4 prior systemic therapies following the initial diagnosis.

To be included in GOG-3129, participants must be / have:  

• Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Have platinum-resistant disease:
• Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum-containing regimen.
• Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.
• Willingness to undergo a pretreatment biopsy. Note: Tissue from a fresh pretreatment biopsy is preferred; however, an archival sample is acceptable as long as the sample is no older than 5 years.
• Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is considered an appropriate next therapeutic option.
• Must have received bevacizumab unless there was a contraindication for its use.
• If the tumor tests positive for FRα, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds.

To be included in GOG-3129, participants must not be / have: 

• Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
• Have primary platinum-refractory disease: either did not respond (CR or PR) to first-line platinum-containing therapy or progressed on or within 3 months after the last dose of the first line platinum-containing therapy.
• The tumor tests positive for FRα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication.
• Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug.
• Known active CNS metastases and/or carcinomatous meningitis.
• Known additional malignancy that is progressing or requires active treatment.

Keywords

ADC; Cancer; Chemotherapy; Gynecologic oncology; Ovarian cancer