US-based biotechnology company Amgen (NASDAQ: AMGN) has published the results from the Phase III study (AALL1731) for its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) at the 66th American Society of Hematology (ASH) annual meeting. The study assessed the potential of adding Blincyto to chemotherapy to improve disease-free survival (DFS) in newly diagnosed pediatric patients with National Cancer Institute (NCI) standard risk (SR) B-cell acute lymphoblastic leukemia (B-ALL).
AALL1731 Study Design and Findings
The AALL1731 study enrolled 4264 patients with newly diagnosed NCI SR B-ALL. As of June 30, 2024, 1440 eligible and assessable patients were randomized. The first pre-specified interim analysis indicated that the primary endpoint of DFS was met, leading to the early termination of study randomization based on the recommendation from the data and safety monitoring committee. The 3-year DFS was 96.0% for patients treated with chemotherapy plus Blincyto, compared to 87.9% for those treated with only chemotherapy. The safety profile of Blincyto was consistent with previous reports.
Blincyto’s Mechanism and Global Impact
Blincyto is the world’s first immunotherapy for use in adult patients with relapsed or refractory (r/r) precursor B-cell ALL. It works by binding to CD19 expressed on B-lineage cells and CD3 expressed on T cells, promoting T cell immune response and leading to cancer cell apoptosis. Amgen, the originator of Blincyto, granted China-based BeiGene Ltd (NASDAQ: BGNE; HKG: 6160) development rights for Greater China in a broad partnership established in November 2011.
Approval History and Global Reach
Blincyto was approved to treat ALL in the US and Europe in 2014 and 2015, respectively, and gained approval in China for adult and pediatric recurrent or refractory (R/R) B-ALL in December 2020 and May 2022.-Fineline Info & Tech
