Update on DASISION trial of Sprycel for PH-CP-CML- BMS/Otsuka
Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc. announced four-year follow-up data from the Phase III DASISION study of Sprycel (dasatinib) 100 mg once daily vs. imatinib (400 mg daily) in the first-line treatment of adults with Philadelphia chromosome-positive (Ph+) chronic phase Chronic Myeloid Leukemia (CP-CML). At four years, 76% of Sprycel patients vs. 63% of imatinib patients achieved a major molecular response (MMR). Additionally, 84% of Sprycel patients vs. 64% of imatinib patients achieved BCR-ABL greater or equal to 10% at three months, which is considered an optimal molecular response as defined by treatment guidelines (2013 European LeukemiaNet guidelines). Patients in both arms who achieved this response at three months had improved overall survival (OS) and progression-free survival (PFS) at four years vs. those who did not. At four years, 67% of Sprycel patients (n=172) and 65% of imatinib patients (n=168) remained on treatment. These data were presented today at the 55th Annual Meeting of the American Society of Hematology (Abstract #653).