Phase III E1910 trial of Blincyto showing benefits over standard care in B-lineage acute lymphoblastic leukemia (B-ALL) presented at ASH.- Amgen

This is the first study to demonstrate superior overall survival (OS) with Blincyto added to consolidation chemotherapy over current standard of care (multiagent consolidation chemotherapy) in newly diagnosed adult patients with Philadelphia chromosome-negative B-ALL who were measurable residual disease (MRD)-negative following induction and intensification chemotherapy.

The Phase III randomized trial (E1910), activated in December 2013, evaluated the safety and efficacy of Blincyto added to standard of care consolidation chemotherapy compared to chemotherapy alone in patients with newly diagnosed B-ALL with no MRD after induction and intensification chemotherapy. The primary endpoint was OS and key secondary endpoints included relapse-free survival, MRD status, and incidence of adverse events. Based on a recommendation by the ECOG-ACRIN Data Safety Monitoring Committee and consistent with the pre-defined efficacy threshold, results from the planned interim analysis are now reported due to overwhelming efficacy reported in the Blincyto arm.

With a median follow up of 43 months, the study met its primary endpoint with a significant improvement in overall survival favoring the Blincyto arm; median OS was not reached vs. 71.4 months in the control arm (hazard ratio [HR] = 0.42, 95% CI: 0.24 - 0.75; two-sided p=0.003). After about 3.5 years of follow-up, 83% of the patients who went on to receive additional standard consolidation chemotherapy plus experimental Blincyto were alive versus 65% of those who received chemotherapy only. No new safety signals were reported for the combination. Data from the trial will be submitted to global regulatory authorities, including where Blincyto has been previously approved. These results were featured in a press briefing on Monday, Dec. 12 at 8:30 a.m. CT and presented on Tuesday, Dec. 13 at 9 a.m. CT as a late breaking oral presentation (LBA1) at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition in New Orleans.