The overall survival duration of patients with relapsed or refractory acute lymphoblastic leukaemia (ALL) is <6 months; a major treatment goal in this heavily-pretreated population is to induce remission to enable patients to undergo stem-cell transplantation. The surface antigen CD19 is expressed on >90% of ALL cells, making this an attractive therapeutic target. The bispecific T-cell engager antibody blinatumomab binds to CD19-positive ALL cells, enabling the patient's own endogenous T cells to recognize and eliminate ALL blast cells. In a phase II study, this agent showed encouraging efficacy in patients with ALL. Now, the results of a phase III randomized trial demonstrate that blinatumomab significantly improves overall survival compared with that observed with standard-of-care chemotherapy.
In total, 405 patients with heavily pretreated ALL were randomly assigned in a 2:1 ratio to receive blinatumomab or chemotherapy. Overall survival was significantly longer (7.7 months versus 4 months) in the blinatumomab arm. The complete remission rate 12 weeks after therapy initiation (34% versus 16%), and the event-free survival (31% versus 12%) were also significantly higher in patients receiving blinatumomab compared with chemotherapy. Importantly, the duration of remission was prolonged (7.3 months versus 4.6 months) with blinatumomab. Adverse events of grade 3 or higher were lower in the blinatumomab group (87% versus 92%).
Hagop Kantarjian, lead author of the study, comments on these findings: “these randomized trial data enhance the notion that monoclonal antibody therapies will play a significant part in improving outcomes in ALL”. These promising results have implications for future research: “We should investigate blinatumomab and other monoclonal therapies in combination with chemotherapy as both salvage and frontline treatments in adults with ALL,” concludes Kantarjian.
References
Kantarjian, H. M. et al. Blinatumomab versus chemotherapy for advanced acute lymphoma leukemia. N. Engl. J. Med. 376, 836–847 (2017)
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Hutchinson, L. New standard for relapsed ALL. Nat Rev Clin Oncol 14, 264 (2017). https://doi.org/10.1038/nrclinonc.2017.42
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DOI: https://doi.org/10.1038/nrclinonc.2017.42