Amgen Reports Results From Two Studies Of Blincyto in Adolescent Leukemia Patients

   By Stephen Nakrosis

Amgen Inc. (AMGN) on Tuesday said results from a Phase 3 study of Blincyto, a treatment for certain pediatric leukemia patients, met their primary endpoint of event-free survival.

The company said the open-label, randomized, controlled global multicenter Phase 3 trial "evaluated the efficacy, safety and tolerability of Blincyto, or blinatumomab, compared to conventional consolidation chemotherapy in pediatric patients with high-risk, B-cell acute lymphoblastic leukemia at first relapse."

The company said enrollment in the study was halted early "due to encouraging efficacy in the Blincyto arm."

A second study of Blincyto, conducted by the Children's Oncology Group, was also halted early "based on a strong trend toward improved disease-free survival and improved overall survival, markedly lower toxicity, and better minimal residual disease clearance," Amgen said.

"Considered together, the results of these studies are remarkable. Children and adolescents who relapse with acute lymphoblastic leukemia face a poor prognosis and there remains a need for additional treatment options, particularly for those that are identified as high-risk. These data have the potential to be practice-changing and may provide a treatment approach to prevent further relapse that is superior to chemotherapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

September 24, 2019 17:09 ET (21:09 GMT)

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