BMS presents additional data at ASH for liso-cel from TRANSCEND CLL 004 study for chronic lymphocytic leukemia or small lymphocytic lymphoma.

Bristol-Myers Squibb Company announced data from multiple studies evaluating lisocabtagene maraleucel (liso-cel), an investigational CD19-directed CAR T-cell therapy with a defined composition of purified CD8+ and CD4+ CAR T cells, were presented during the 2019 ASH Annual Meeting in Orlando, Fla. These studies included an evaluation of liso-cel in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) (TRANSCEND CLL 004); a study in second-line patients with relapsed or refractory large B-cell non-Hodgkin's lymphoma (NHL) patients who were ineligible for high-dose chemotherapy and hematopoietic stem cell transplant (HSCT) (PILOT); and a separate analysis of patients with relapsed/refractory large B-cell non-Hodgkin lymphoma who received liso-cel in the outpatient setting across three studies.

TRANSCEND CLL 004 : In the phase 1/II TRANSCEND CLL 004 study, at the data cutoff, 23 patients with CLL/SLL who had received at least three (standard-risk disease) or two (high-risk disease) prior treatments were evaluable for safety, with 22 patients evaluable for efficacy. Patients had a median of 5 prior lines of therapy (range 2-11). All patients (23/23) had received prior ibrutinib and most (21/23) were refractory to or had relapsed on the BTK inhibitor. There were nine patients (39%) that had failed both a BTK inhibitor (progressed on treatment) and venetoclax (did not achieve a response after at least 3 months). Most patients (83%) had high-risk features including deletion 17p (35%, 8/23) and TP53 mutation (61%, 14/23). Patients received liso-cel target doses of either 50 � 106 (n=9) or 100 � 106 (n=14) CAR+ T cells following lymphodepletion. Treatment-emergent adverse events (TEAE) of any grade occurred in 100% (23/23) of patients with 96% (22/23) of patients experiencing a grade 3 or higher TEAE. The most common grade 3 or higher TEAEs occurring in at least 25% of patients were anemia (78%, 18/23), thrombocytopenia (70%, 16/23), neutropenia (56.5%, 13/23), leukopenia (43.5%, 10/23), febrile neutropenia (26%, 6/23), lymphopenia (26%, 6/23) and cytokine release syndrome (9%, 2/23). Seventy-four percent (17/23) of patients had cytokine release syndrome (CRS) of any grade with 9% of patients (2/23) experiencing grade 3 CRS. Thirty-nine percent (9/23) of patients had neurological events (NE) of any grade, while 22% (5/23) of patients had grade 3 or higher NE. Median time to onset of CRS was 4 days (range 1-10 days) and of NE was 4 days (range 2-21). Incidence and severity of CRS and NEs were similar for patients who failed a BTK inhibitor and venetoclax. Seventy-four percent (17/23) of patients received tocilizumab and/or corticosteroids. There were no grade 5 events.