News that has taken the Pharmaceutical sector by storm, Amgen has announced positive results for 2 phase 3 BLINCYTO® (blinatumomab) studies in pediatric patients with relapsed acute lymphoblastic leukemia.
Amgen announced the results of a pre-specified interim analysis of an open-label, randomized, controlled global multicenter phase 3 trial showed that the primary endpoint of event-free survival was met. The study analyzed and evaluated the adequacy of BLINCYTO® (blinatumomab) the conventional consolidation chemotherapy in pediatric patients with high risk. Enrollment was aborted early due to encouraging efficacy in the BLINCYTO arm and as a result of a recommendation from the Independent Data Monitoring Committee. Follow up to all this will continue as per the as compared to protocol.
Apart from this, a random Phase 3 trial which was conducted by the Children’s Oncology Group using BLINCYTO in pediatric B-cell, all patients at first relapse closed to accrual for the high and intermediate risk-arm based on the recommendation by COG DMC. The decision was based on a strong trend towards improved disease-free survival and also improved overall survival, lower toxicity and comparatively better minimal residual disease clearance for BLINCYTO compared to chemotherapy.
As per David M Reese, M.D, executive vice president of R & D at Amgen the results of the studies conducted are remarkable. Children who relapse with acute lymphoblastic leukemia face poor prognosis and there is always a requirement of additional treatment options at least for those that are identified as high-risk. What has been found out has the potential to be practice-changing and may provide a treatment approach superior to chemotherapy that might prevent further relapse.