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10 Dec 2013

BMS Presents 4-Year Data from Phase III DASISION Trial

Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc. have announced 4-year follow-up data from the Phase III DASISION study of Sprycel (dasatinib) 100 mg once daily versus imatinib (400 mg daily) in the first-line treatment of adults with Philadelphia chromosome-positive (Ph+) chronic phase chronic myeloid leukemia (CP-CML).


At 4 years, 76% of Sprycel patients versus 63% of imatinib patients achieved a major molecular response (MMR).1,2 In addition, 84% of Sprycel patients versus 64% of imatinib patients achieved BCR-ABL ≤10% at 3 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 3 months had improved overall survival (OS) and progression-free survival (PFS) at 4 years versus. those who did not. At 4 years, 67% of Sprycel patients (n=172) and 65% of imatinib patients (n=168) remained on treatment. These data were presented at the 55th 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 localised 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 4 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 MD Anderson Cancer Center. “These data also offer important insights on the potential impact that early responses might have on patient outcomes in this setting.”


“This longer term analysis from our Phase III trial provides further evidence of the sustained efficacy of Sprycel in the first-line setting and adds to our understanding of its safety in patients treated for several years,” said Michael Giordano, senior vice president, Head of Development, Oncology & Immunology, Bristol-Myers Squibb. “Sprycel remains an important therapy for many CML patients and we are committed to continuing its research in CML, with the goal of improving patient outcomes and informing medical practice.”

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