BMS announced data at ASH meeting from TRANSCEND NHL 001 study evaluating liso-cel in relapsed or refractory mantle cell lymphoma.

Bristol Myers Squibb announced data from multiple studies evaluating lisocabtagene maraleucel (liso-cel), an investigational CD19-directed chimeric antigen receptor (CAR) T cell therapy, in relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in relapsed or refractory mantle cell lymphoma (MCL) were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. Initial results from the combination cohort with ibrutinib, and safety and preliminary efficacy results from TRANSCEND NHL 001 in the cohort of patients with relapsed or refractory MCL treated with liso-cel were presented. Safety and Efficacy of Liso-cel in Relapsed or Refractory MCL: TRANSCEND NHL 001 : In the TRANSCEND NHL 001 study cohort of patients with relapsed or refractory MCL, including many with highly proliferative disease, 32 patients received liso-cel across dose levels of 50 x 106 CAR positive T cells and 100 x 106 CAR positive T cells (Presentation #118). Sixteen patients (50%) experienced any grade CRS, including one Grade greater than 3 event. Median time to CRS onset and resolution was six days (2?10) and four days (2-9), respectively. Eleven patients (34%) experienced any grade NEs, all of which occurred in those who received the higher dose level, including four Grade greater than 3 NEs. Median time to NE onset and resolution was eight days (2-25) and four days (1-27), respectively. Preliminary efficacy results showed that treatment with liso-cel resulted in high response rates with 84% of patients responding to treatment and 66% of patients achieving a complete response (CR) . Overall, the median time to first complete or partial response was less than one month (0.95; range 0.9-2.0). Median duration of response was not reached with a median follow-up of 3.9 months (0.0-21.3).