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ASH 2025 | Single-agent SC blinatumomab in R/R B-ALL: Phase I/II efficacy results with extended follow-up

Elias Jabbour, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, discusses a Phase I/II dose-expansion study (NCT04521231) evaluating the efficacy of single-agent subcutaneous (SC) blinatumomab in adults with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). Dr Jabbour highlights the advantages of this route of administration, including convenience and the ability to deliver higher doses. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.

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Transcript

Blinatumomab is given IV over four weeks, every six weeks. It’s converse. Subcutaneous blinatumomab offers two advantages. One is convenience. You’re given three times per week. But then you can deliver a higher dose compared to IV Blinatumomab. And in fact, in this patient population enrolled, patients are refractory, failed IV blinatumomab, failed CAR T-cells to isatuximab. We’ve seen 70% response rate, and among responders, high MRD negativity rate...

Blinatumomab is given IV over four weeks, every six weeks. It’s converse. Subcutaneous blinatumomab offers two advantages. One is convenience. You’re given three times per week. But then you can deliver a higher dose compared to IV Blinatumomab. And in fact, in this patient population enrolled, patients are refractory, failed IV blinatumomab, failed CAR T-cells to isatuximab. We’ve seen 70% response rate, and among responders, high MRD negativity rate. And then we have not seen any signal of safety at the long run compared to what we published before. The survival at 12 months, 60% median has not been reached, which is by far better than what we had before. And furthermore, those who responded, transplant did not seem to add anything. The recommended phase two dose is 250 micrograms daily for the first week and 500 micrograms three times per week from week two and onward and subsequent courses. And right now we are running the phase two trial and the ODEX frontline trial will be opening in January to seek an approval in frontline indication.

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