Trial ID # | NCT03531645 |
Phase | II |
Drug Class | Cell Cycle Inhibitors: CDK4/6 |
Drug Name | Abemaciclib |
Alternate Drug Names | Bemaciclib, LY2853219, CDK4/6 Dual Inhibitor LY2835219, Verzenio |
Drugs in Trial | Abemaciclib, Fulvestrant |
Eligible Participant | Newly diagnosed stage III/IV unresectable low grade serous ovarian cancer |
Patients Enrolled | 15 |
Therapy Setting | First-line |
Study Design | Open-Label, Non-randomized |
Endpoints | ORR, DCR, evaluated per RECIST |
Efficacy | ORR: 60% (1CR, 7PR) 7 patients w/ IDS: |
Clinically Significant Adverse Events | Serious AE: none |
Conclusion | Neoadjuvant treatment with fulvestrant and abemaciclib is tolerable and demonstrates unprecedented response and complete gross resection rates in Low Grade Serous ovarian cancer |
Reference | Cobb LP et al. A pilot phase II study of neoadjuvant fulvestrant plus abemaciclib in women with advanced low-grade serous carcinoma. J Clin Oncol 40, 2022 (suppl 16; abstr 5522) Cobb LP et al. Poster |