Bristol-Myers Squibb Company
(NYSE:BMY) and Otsuka America Pharmaceutical, Inc. today announced four-year follow-up data from the Phase 3 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 ≤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 55
Annual Meeting of the American Society of Hematology (Abstract #653).
Most drug-related adverse events occurred within the first year of treatment, and the types of safety events were consistent through year four. Adverse reactions reported in ≥10% of Sprycel-treated patients with newly diagnosed CP Ph+ CML were myelosuppression, fluid retention events (pleural effusion and superficial localized edema), diarrhea, headache, musculoskeletal pain, rash, and nausea. In Sprycel-treated patients, most grade 3-4 adverse events were hematologic lab abnormalities and occurred within the first year.
“These findings are based on four years of follow-up in patients and provide additional insights regarding the safety and efficacy of Sprycel in newly-diagnosed Ph+ CP-CML patients,” said Dr. Jorges E. Cortes, University of Texas M.D. Anderson Cancer Center. “These data also offer important insights on the potential impact that early responses might have on patient outcomes in this setting.”