Positive results for Blinctyo in pediatric patients with high-risk, B-cell acute lymphoblastic leukemia.- Amgen

Amgen has announced that the results of a prespecified interim analysis of an open-label, randomized, controlled global multicenter Phase III trial (20120215) showed that the primary endpoint of event-free survival was met. The study evaluated the efficacy, safety and tolerability of Blincyto (blinatumomab) compared to conventional consolidation chemotherapy in pediatric patients with high-risk, B-cell acute lymphoblastic leukemia (ALL) at first relapse. Enrollment was terminated early due to encouraging efficacy in the Blincyto arm and was based on a recommendation from the Independent Data Monitoring Committee (DMC).

Follow up will continue as prescribed per protocol. In addition, a randomized, Phase III trial (AALL1331) conducted by the Children's Oncology Group (COG) using Blincyto in pediatric B-cell ALL patients at first relapse has closed to accrual for the high-risk and intermediate risk-arm based on the recommendation of the COG DMC. The DMC closure decision was based on a strong trend towards improved disease-free survival and improved overall survival, markedly lower toxicity, and better minimal residual disease (MRD) clearance for Blincyto compared to chemotherapy. The COG DMC recommended that the AALL1331 low-risk group continue to enroll and randomize patients until enrollment goals are reached. AALL1331 is sponsored by the Cancer Therapy Evaulation Program of the National Cancer Institute (NCI), part of the National Institutes of Health, and is conducted by the NCI-funded COG. Amgen provided Blincyto for AALL1331 under a Collaborative Research and Development Agreement between the NCI and Amgen.

The Blincyto adverse events observed in the Phase III 20120215 and the COG AALL1331 studies were consistent with the known safety profile of Blincyto. These interim data will be submitted to a future medical conference and for publication.