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www.fdanews.com/articles/205225-bespoke-car-t-therapies-post-strong-results-in-b-cell-lymphoma-studies

Bespoke CAR-T Therapies Post Strong Results in B-Cell Lymphoma Studies

November 8, 2021

Two CAR-T treatments — one from Gilead Sciences and another from Bristol Myers Squibb (BMS) — trounced standard-of-care as second-line therapies for patients with relapsed or refractory large B-cell lymphomas in two late-stage studies.

In the phase 3 trials, two-year event-free survival was 41 percent with Gilead’s Yescarta (axi-cel).  With BMS’s Breyzani (liso-cel), the average time of event-free survival was 10 months. Both results were significant improvements over the comparator treatments.

The companies had previously announced positive topline results, saying more details would be released at the December meeting of the American Society of Hematology. Abstracts now online showed the magnitude of response in both phase 3 studies.

Both treatments remove white blood cells from the patients, genetically modify them to recognize the patient’s individual tumor and then reinfuse the bespoke CAR-T treatment.

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