Japanese Ministry of Health, Labour and Welfare has granted marketing approval for Blincyto (blinatumomab) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia. Blincyto was developed in Japan by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma Inc., a pharmaceutical company headquartered in Tokyo.
Blincynto is sponsored by Amgen Inc.
Blincyto is the first-and-only bispecific T cell engager immunotherapy construct approved globally. It is also the first approved immunotherapy from Amgen’s BiTE platform, an innovative approach that helps the body’s immune system target cancer cells.
The approval is based on data from multiple global studies, including the phase III TOWER study and Japan phase Ib/II Horai study. In the TOWER study, Blincyto demonstrated a superior improvement in median overall survival versus standard of care chemotherapy.
Median OS was 7.7 months (95% CI: 5.6, 9.6) for Blincyto versus 4.0 months (95 percent CI: 2.9, 5.3) for SOC (HR for death=0.71; p=0.012). Safety results among subjects who received Blincyto were comparable to those seen in the previous phase II studies of Blincyto in adult patients with Philadelphiachromosome-negative relapsed or refractory B-cell precursor ALL.
In the phase Ib/II Horai study, Blincyto was administered to 35 Japanese adult and pediatric patients with relapsed or refractory B-cell precursor ALL. The safety results from the Horai study were comparable to those seen in the global studies, including TOWER.
Blincyto is now approved in 57 countries, including the U.S., all member countries in the European Union and the European Economic Area, Canada and Australia.
The TOWER study was a phase III, randomized, active-controlled, open-label study investigating the efficacy of Blincyto versus SOC chemotherapy in 405 adult patients with Ph- relapsed or refractory B-cell precursor ALL.
The study enrolled a difficult-to-treat patient population which included patients with one or more relapses or refractory disease. In the Blincyto arm, this included 35 percent of patients that had relapsed post-allogenic hematopoietic stem cell transplant and excluded those with late first relapse (≥12 months after initial remission).
Patients were randomized in a 2:1 ratio to receive Blincyto (n=271) or treatment with investigator choice of SOC chemotherapy (n=134). The determination of efficacy was based on OS. These results were published in The New England Journal of Medicine.
The Horai study is a phase Ib/II, single-arm, open-label study evaluating the safety and efficacy of Blincyto in Japanese adult and pediatric patients with relapsed or refractory B-cell precursor ALL. The primary endpoint for the phase Ib portion was incidence of dose-limiting toxicities; the primary endpoint for the phase II portion was complete remission or complete remission with partial hematologic recovery within 12 weeks of treatment with Blincyto. Secondary endpoints include duration of response, OS and relapse-free survival. An extension of the study is ongoing.
