Bristol-Myers Squibb and Otsuka Pharma said that the study results were consistent with 12-month data in which Sprycel demonstrated higher and faster rates of complete cytogenetic response (CCyR)and major molecular response [1] (MMR) compared to imatinib.
The study results revealed that 78% of the patients treated with Sprycel achieved confirmed CCyR by 18 months, compared to 70% were treated with imatinib.
MMR at any time was 57% for patients treated with Sprycel compared to 41% for patients treated with imatinib.
The most frequently reported serious adverse reactions in patients receiving Sprycel included pleural effusion, hemorrhage, congestive heart failure and pyrexia.
About six patients receiving Sprycel had transformation to accelerated or blast phase, compared to nine patients who were receiving imatinib.
The open-label, randomised, Phase III international trial compared Sprycel 100mg taken once daily versus imatinib 400mg taken once daily.
The study enrolled 519 patients, in which 259 patients were randomised to receive Sprycel and 260 patients were randomised to receive imatinib.
The primary endpoint of the study was the rate of confirmed CCyR by 12 months, while the secondary endpoints included time-to confirmed CCyR, MMR rate and time-to MMR.