Rigosertib did not significantly improve overall survival compared with best supportive care for patients with high-risk myelodysplastic syndromes (MDS) after failure of hypomethylating drugs. This according to a study of 299 patients with MDS, including 199 receiving rigosertib and 100 receiving best supportive care; all were followed up for a median 19.5 months. Researchers found:

• Median overall survival was 8.2 months with rigosertib and 5.9 months with best supportive care.

• Most common grade 3 or higher adverse events were anemia (18% vs 8%), thrombocytopenia (19% vs 7%), neutropenia (17% vs 8%), febrile neutropenia (12% vs 11%), and pneumonia (12% vs 11%) in the rigosertib group and best supportive care group, respectively.

• 22% of patients in the rigosertib group and 33% of patients in the best supportive care group died due to adverse events.

• 3 deaths were attributed to rigosertib treatment.

Citation: Garcia-Manero G, Fenaux P, Al-Kali A, et al. Rigosertib versus best supportive care (ONTIME): a randomised, controlled, phase 3 trial. [Published online ahead of print March 8, 2016]. Lancet Hematol. doi:10.1016/S1470-2045(16)00009-7.