A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer

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


Study Design

Open-Label, Non-randomized


ORR, DoR, PFS, OS, evaluated per RECIST


Bin (n=201) vs Chemotherapy Treatment of Physician's Choice (TPC, n=102) (liposomal doxorubicin, paclitaxel or topotecan):

ORR: 24 vs 24%
PFS: 11.2 vs 14.1 months, HR: 1.12 (0.81-1.53)
DoR: 8.1 vs 6.7 months
OS: 25.3 vs 20.8 months, HR: 0.85 (0.49-1.48)

Exploratory analysis, KRAS status, MAPK pathway alteration (KRAS, NRAS, BRAF V600E, RAF1, NF1):
Bin: KRAS MUT (n=46) vs KRAS WT (n=98): ORR: 44 vs 19% (p=0.003); PFS: 17.7 vs 10.8 months (p=0.006)
TPC: KRAS MUT (n=24) vs KRAS WT (n=47): PFS: 14.6 vs 11.5 months (p=0.502)
Bin: w/ MAPK pathway alterations vs w/o MAPK pathway alterations: ORR: 41 vs 13%; PFS: HR 0.5 (0.31-0.79, p = 0.003)
TPC: w/ MAPK pathway alterations vs w/o MAPK pathway alterations: PFS: HR 0.82 (0.43-1.59, p = 0.6)

Clinically Significant Adverse Events

Bin vs Chemotherapy Treatment of Physician's Choice (TPC) (liposomal doxorubicin, paclitaxel or topotecan):
Serious AE:
Grade 3-4 AE: Overall (76 vs 44%)
Binimetinib: vomiting (10%)


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


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

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