Biopharmaceutical company Array BioPharma is planning to stop the MILO study, which is an international, randomised phase 3 trial of binimetinib for treatment of patients with low-grade serous ovarian cancer.
After undertaking a planned interim analysis, which revealed that the Hazard Ratio for Progression Free Survival (PFS) crossed the predefined futility boundary, Array decided to discontinue the study.
Array stated that it will work with investigators to appropriately conclude the MILO study in a way that considers the best interest of each patient, while more detailed results will be shared with the scientific community in the future.
Array chief medical officer Victor Sandor said: "While we are disappointed by this outcome, the findings from MILO have no impact on the other studies of binimetinib, including the NEMO trial, which has already met its primary endpoint, and the COLUMBUS trial, which is designed to test a highly precedented combination of mechanisms in patients with BRAF-mutant melanoma."
All other current studies of binimetinib, such as the Phase 3 BRAF-mutant melanoma (COLUMBUS) and NRAS-mutant melanoma (NEMO) trials, will be continued.
Top-line results from the study had been expected in 2017.
The trial’s primary endpoint is PFS and secondary endpoints cover overall survival, overall response rate, duration of response, disease control rate, safety and quality of life.
Binimetinib is in late-stage of development, with a primary phase 3 programme (COLUMBUS) in BRAF-mutant melanoma in combination with BRAF inhibitor, encorafenib.
The drug is also being investigated in a phase 3 study (NEMO) in patients suffering from NRAS-mutant melanoma.
