Bristol-Myers Squibb Company and Otsuka Pharmaceutical Europe Ltd., today announced six-year follow-up results from a Phase 3 randomised, open-label, dose-optimisation study of SPRYCEL(R) (dasatinib) in Philadelphia chromosome-positive (Ph+) chronic-phase chronic myeloid leukaemia (CP-CML) adult patients resistant or intolerant to Glivec(R) (imatinib).
Long-term survival data
The six-year data shows progression-free survival of 49.3% and an overall survival of 71% for patients randomised to dasatinib 100 mg once daily (n=167), with 6% of patients (n=10) progressing to accelerated or blast phase on study at six years of follow-up.
Safety and tolerability data from patients randomized to the 100 mg arm during the six-year follow up are consistent with the previously reported safety profile of dasatinib 100 mg once daily. In this 100 mg QD arm, the most common grade 3/4 adverse events (AEs) were (cumulative 6 year occurrence): neutropenia (36%), thrombocytopaenia (24%), and anaemia (13%).[1] The cumulative incidence rates of the most common non-haematological AEs of Grade 3/4 at six years of follow-up were: diarrhoea (4.3%), fatigue (4.3%), infections (6.1%) and pleural effusion (5.3%).
This is the longest reported follow-up of 2nd generation Tyrosine Kinase Inhibitors for patients resistant or intolerant to imatinib.
Safety and Tolerability at Six Years
Safety and tolerability data from the six-year study are consistent with the previously reported safety profile of dasatinib 100 mg once daily. For full information on SPRYCEL (dasatinib) please refer to SmPC athttp://www.ema.europa.eu.
These data was presented at the 17th Congress of the European Hematology Association in Amsterdam.
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