Four-year follow-up results from SPRYCEL Phase 3 study in CML-CP presented at ASCO

Jun 9 2010

Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL^® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients resistant or intolerant to Gleevec^®* (imatinib mesylate). At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%).

“As a researcher and clinician, I find these results to be very encouraging.”

These data were presented at the 46^th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. (Abstract #6512)

The four-year safety data from this study are consistent with the previously reported safety profile of SPRYCEL 100 mg once daily. The long-term data from this study also demonstrated that adverse events with SPRYCEL 100 mg once daily occurred primarily within the first 24 months of treatment.

"These four year-data for SPRYCEL in the second-line setting add to our growing body of knowledge of this medication and the treatment of CML overall," said Neil Shah, MD, PhD, Assistant Professor, Division of Hematology/Oncology, University of California, San Francisco and principal investigator of the study. "As a researcher and clinician, I find these results to be very encouraging."