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MILO/ENGOT-ov11

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

Phase 3NCT01849874

Population
Recurrent or persistent low-grade serous carcinoma of the ovary, fallopian tube or peritoneum after at least one and up to three prior chemotherapy lines; 303 patients had been randomised at the interim analysis and 341 had enrolled at closure
Design
Randomised 2:1, open-label phase 3 study (102 sites in 20 countries, per the full text) of binimetinib 45 mg twice daily versus physician's-choice chemotherapy in recurrent measurable low-grade serous carcinoma after at least one prior platinum-based chemotherapy and no more than three prior chemotherapy lines. Primary end point PFS by blinded independent central review. The study closed early after crossing a prespecified futility boundary.
Primary endpoint
PFS
Arms
  • Binimetinib (experimental): Binimetinib 45 mg twice daily
  • Physician's-choice chemotherapy (control): Physician's-choice chemotherapy
People
Monk BJ
PFSHR 1.21 (95% CI 0.79–1.86)Δ median PFS−1.5 monthsΔ ORR+3 points
Show the numbers
Results reported for MILO/ENGOT-ov11
EndpointAnalysisBinimetinibPhysician's-choice chemotherapyEffect
PFSPatients randomised at the interim analysis (n=303)interimMonk 2020median 9.1 months (7.3–11.3)median 10.6 months (9.2–14.5)HR 1.21 (95% CI 0.79–1.86)Interim analysis of 20 January 2016, which crossed the prespecified futility boundary; the study closed after 341 patients had enrolled. The updated analysis (n=341, January 2019) was reported as consistent.
ORRPatients randomised at the interim analysis (n=303)interimMonk 202016%13%Secondary end point at the interim analysis.
Results reported for MILO/ENGOT-ov11
EndpointAnalysisBinimetinibPhysician's-choice chemotherapyEffect
PFSPatients randomised at the interim analysis (n=303)interimMonk 2020median 9.1 months (7.3–11.3)median 10.6 months (9.2–14.5)HR 1.21 (95% CI 0.79–1.86)Interim analysis of 20 January 2016, which crossed the prespecified futility boundary; the study closed after 341 patients had enrolled. The updated analysis (n=341, January 2019) was reported as consistent.
ORRPatients randomised at the interim analysis (n=303)interimMonk 202016%13%Secondary end point at the interim analysis.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS1.210.79–1.86
Illustrative — modelled from reported values, not trial data. PFS, interim.
0%25%50%75%100%0510152025Months (modelled)
  • Binimetinib (experimental)
  • Physician's-choice chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsBinimetinibPhysician's-choice chemotherapy
0100.0%100.0%
758.7%63.3%
1337.1%42.7%
2021.8%27.0%
2712.8%17.1%
Primary publication: Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, 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. PubMedDOI

Appears in

Sources

  1. Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, 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.

    PubMedDOI