David L. Porter, MD
Saying that the treatment is “poised to transform the outlook for children and adults with certain otherwise incurable cancers,” ASCO has selected CAR T-cell therapy as its Advance of the Year.
“The patients who participated in the early clinical trials of this therapy at Penn starting nearly 8 years ago are pioneers, whose stories are now part of medical history. Our experiences developing this therapy and caring for these patients have revolutionized our belief about what is possible in oncology, and galvanized us as we move into adapting CAR T-cell therapies for the treatment of solid tumors,” added Porter.
Tisagenlecleucel won approval based on results from the phase II, single-arm, international ELIANA trial of 63 patients who received a single dose of tisagenlecleucel. The overall remission rate was 82.5% (95% CI, 70.9-91.0) in treated patients. Forty patients (63%) had complete remission (CR) and 12 (19%) had complete remission with incomplete hematologic recovery (CRi). All patients who had CR or CRi also had negative minimal residual disease status in the bone marrow.
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