Six-year follow up on Phase III study of Sprycel (BMS / Otsuka) shows positive results for CML patients

Results from a Phase III study of Sprycel (dasatinib), from BMS and Otsuka, in Philadelphia chromosome-positive (Ph+) chronic-phase chronic myeloid leukaemia (CP-CML) adult patients shows progression-free survival of 49.3% and an overall survival of 71% with 6% of patients progressing to accelerated or blast phase on study at six years of follow-up. Study CA180-034 was designed to assess the efficacy and safety of dasatinib following intolerance or resistance to imatinib. The trial enrolled 670 CP-CML patients with resistance (n=497) or intolerance (n=173) to imatinib. As well as the PFS results, thirty-one percent of patients randomised to receive dasatinib 100 mg once daily remained on treatment at 6 years. Safety and tolerability data are consistent with the previously reported safety profile of dasatinib. The most common adverse events were neutropenia (36%), thrombocytopaenia (24%), and anaemia (13%). This is the longest reported follow-up of 2nd generation Tyrosine Kinase Inhibitors for patients resistant or intolerant to imatinib. Data were presented at the 17th Congress of the European Hematology Association meeting.