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ASH 2020 | Preliminary results from Phase I trial of liso-cel plus ibrutinib for R/R CLL

William Wierda, MD, PhD, University of Texas MD Anderson Cancer Center, Houston, TX, outlines the preliminary safety and efficacy results from the Phase I cohort receiving lisocabtagene maraleucel (liso-cel) plus ibrutinib in the ongoing TRANSCEND-CLL-004 study (NCT03331198) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). Preliminary data showed a manageable safety profile, with a low incidence of grade 3 cytokine release syndrome and neurological events, and promising efficacy with a 95% overall response rate. 83% of patients maintained their response at the 3-month follow-up. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.

Transcript (edited for clarity)

The TRANSCEND study, as I mentioned, there were two dose levels that were studied for liso-cel. One is monotherapy, the other in combination with ibrutinib. The monotherapy or single agent cohort has been previously reported at other meetings. The combination cohort has not yet been reported. And the single agent cohort showed that again, there’s activity, particularly in a heavily pretreated population of patients...

The TRANSCEND study, as I mentioned, there were two dose levels that were studied for liso-cel. One is monotherapy, the other in combination with ibrutinib. The monotherapy or single agent cohort has been previously reported at other meetings. The combination cohort has not yet been reported. And the single agent cohort showed that again, there’s activity, particularly in a heavily pretreated population of patients. Liso-cel is safe in patients with CLL, with a reasonable expectation for cytokine release and neurotoxicity that’s very manageable. And I think the important point with the monotherapy cohort that’s being presented is the durability around those responses that we’ve seen with single agent liso-cel in a heavily pretreated population of patients.

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