Follow-Up Data Added to Sprycel Labeling is Among Longest for CML
The labeling for Sprycel (dasatinib; Bristol-Myers Squibb and Otsuka) has been updated with new three-year efficacy and safety data in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase and five-year data in CP Ph+ CML patients who are resistant or intolerant to Gleevec (imatinib mesylate; Novartis).
Information added to the Sprycel label in the first-line CP Ph+ CML setting is based on three-year data from DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CML Patients), an open-label, randomized, Phase 3 international trial. In the study, Sprycel demonstrated superior efficacy as defined by higher molecular (major molecular response or MMR) and confirmed cytogenetic response rates (CCyR) by 12 months, compared to imatinib.
In DASISION, 77% [95% CI, 71% - 82%] of patients treated with Sprycel (n=259) vs. 66% [95%, CI, 60% - 72%] of patients treated with imatinib (n=260) achieved the primary endpoint of confirmed CCyR (defined as two consecutive assessments of CCyR at least 28 days apart) by 12 months (P=0.007).
After 36 months follow-up, median time to confirmed CCyR was 3.1 months in 214 Sprycel responders and 5.8 months in 201 imatinib responders. In the long-term (by 3 years), confirmed CCyR rates continued to increase (83% Sprycel vs. 77% imatinib).
Sprycel patients were more likely than imatinib patients to achieve MMR, a measure of deeper treatment response, by year one (52% [95% CI, 46% - 58%] vs. 34% [95% CI, 28% - 40%], respectively; P<0.0001). In the long term (by year 3), MMR at any time was higher for Sprycel than imatinib (69% [95% CI, 63% - 75%] vs. 56% [95% CI, 50% - 62%], respectively).
The study also showed higher MMR rates at any time with Sprycel, across all Hasford risk groups vs. imatinib (low risk: 81% vs. 64%; medium risk: 64% vs. 56%; and high risk: 61% vs. 42%). In patients treated with Sprycel the vast majority did not transform to accelerated or blast phase CML by three years (3% with Sprycel and 5% with imatinib).
Information added to the Sprycel labeling for CP Ph+ CML patients with resistance or intolerance to prior imatinib therapy includes data up to six years after the last patient was enrolled in Study CA180-034, a Phase 3 open-label, dose-optimization trial. At five years, 64% of patients were known to be alive with an additional 14% having unknown survival data (the remaining 22% of patients were known to have died prior to five years).
While on treatment, less than 5% of Sprycel patients transformed to accelerated or blast phase CML by five years. The primary endpoint was major cytogenetic response (MCyR) in imatinib-resistant patients; 63% of imatinib-resistant or -intolerant patients taking Sprycel 100 mg once-daily achieved MCyR at two years [95% CI: 56% - 71%].
This new data is among the longest follow-up data of current CML treatment options.