| Trial ID # | NCT01849874; MILO/ENGOT-OV11 |
| Phase | III |
| Drug Class | Signaling Pathway Inhibitors: RAS-RAF-MEK-ERK/MEK |
| Drug Name | Binimetinib |
| Alternate Drug Names | MEK162, MEK inhibitor MEK162, ARRY-162, ARRY-438162, Mektovi |
| Drugs in Trial | Binimetinib, Liposomal doxorubicin, Paclitaxel, Topotecan |
| Eligible Participant | Recurrent low grade serous ovarian cancer with 1-3 prior therapies |
| Patients Enrolled | 303, median 2 prior therapies |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DoR, PFS, OS, evaluated per RECIST |
| Efficacy | Bin (n=201) vs Chemotherapy Treatment of Physician's Choice (TPC, n=102) (liposomal doxorubicin, paclitaxel or topotecan): ORR: 24 vs 24% Exploratory analysis, KRAS status, MAPK pathway alteration (KRAS, NRAS, BRAF V600E, RAF1, NF1): |
| Clinically Significant Adverse Events | Bin vs Chemotherapy Treatment of Physician's Choice (TPC) (liposomal doxorubicin, paclitaxel or topotecan): |
| Conclusion | Binimetinib shows activity in low grade serous ovarian cancer, but chemotherapy responses were higher than expected; higher response rates and longer PFS were seen in patients treated with binimetinib who harbored MAPK pathway mutations, most commonly in KRAS |
| Reference | Monk BJ et al. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol (2020) 38(32):3753-3762 Grisham RN et al. Molecular Results and Potential Biomarkers Identified from the Phase 3 MILO/ENGOT-ov11 Study of Binimetinib vs Physician Choice of Chemotherapy in Recurrent Low-Grade Serous Ovarian Cancer. Clin Cancer Res (2023) 29(20):4068-4075 |