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Lisocabtagene maraleucel demonstrated durable responses and a favorable safety profile in patients with relapsed/refractory large B-cell lymphoma.
Lisocabtagene maraleucel (Breyanzi; liso-cel) demonstrated durable responses and a favorable safety profile in patients with relapsed/refractory large B-cell lymphoma, according to abstract findings from the phase 1 TRANSCEND NHL 001 trial (NCT02631044), which will be presented at the upcoming 2021 ASH Annual Meeting & Exposition.1
As of the data cutoff on January 4, 2021, the objective response rate (ORR) per independent review committee was 73%, with a complete response (CR) rate of 53% in the efficacy-evaluable population (n = 257). The median duration of response (DOR) was 23.1 months (95% CI, 8.6–not reached), the median progression-free survival (PFS) was 6.8 months (95% CI, 3.3-12.7), and the median overall survival (OS) was 27.3 months (95% CI, 16.2-45.6).
The estimated 24-month rates of continued response, PFS, and OS were 49.5% (95% CI, 41.4%-57.0%), 40.6% (95% CI, 34.0%-47.2%), and 50.5% (95% CI, 44.1%-56.5%), respectively.
“CAR T cells are an FDA-approved option for certain types of lymphoma. At this year’s ASH meeting, we will present the 2-year follow up of the TRANSCEND NHL 001 trial, which evaluated the efficacy and safety of liso-cel, a CD19-directed CAR T-cell [therapy], in aggressive B-cell lymphoma,” said M. Lia Palomba, MD, senior study author and a medical oncologist at Memorial Sloan Kettering Cancer Center, in a statement to OncLive®.
“Of the 270 patients who received liso-cel infusion, 73% had an objective response, and 53% [had] a CR. The median DOR was 23.1 months and the probability of PFS at 2 years was 40.6%. Importantly, liso-cel was safe, with only 2% of patients experiencing serious cytokine release syndrome [CRS] and 10% experiencing serious neurological toxicity,” added Palomba.
On February 5, 2021, the FDA approved liso-cel for the treatment of adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least 2 other types of systemic treatment.2
The biologics license application for the anti–CD19-targeted CAR T-cell therapy was granted a priority review designation from the FDA in February 2020. The application was based on earlier findings from the multicenter phase 1 TRANSCEND NHL 001 trial, which showed an ORR of 73% and a CR rate of 53% in patients treated with liso-cel, with the time to first CR or partial response occurring at a median of 1 month.3
In the extended follow-up analysis, 345 patients underwent leukapheresis. In the liso-cel–treated population (n = 270), the median age was 63 years (range, 18-86); 41% of patients were at least 65 years of age.
Histologies included diffuse large B-cell lymphoma not otherwise specified (de novo, 51%; transformed from indolent lymphoma, 29%), high-grade B-cell lymphoma (13%), primary mediastinal large B-cell lymphoma (6%), and follicular lymphoma grade 3B (1%). Seven patients (3%) had secondary central nervous system lymphoma.1
Patients received a median of 3 prior lines of systemic therapy (range, 1-8) and 33% had prior autologous hematopoietic stem cell transplant (HSCT; prior allogeneic HSCT, 3%). Of all patients, 67% were refractory to chemotherapy, 45% had never achieved a CR, and 59% received bridging therapy.
As of the data cutoff, 268 patients had at least 24 months of follow-up, died, or withdrew from the study.
Additional findings indicated that during the 90-day treatment-emergent reporting period, 79% of patients in the liso-cel–treated population (n = 270) had grade 3 or greater treatment-emergent adverse effects (TRAEs); 45% had serious TEAEs.
Any-grade CRS and neurotoxicity occurred in 42% and 30% of patients, respectively (grade 3/4 CRS, 2%; grade 3/4 neurotoxicity, 10%). The median time to onset of CRS and neurotoxicity was 5 days (range, 1-14) and 9 days (range, 1-66), respectively.
Grade 3 or greater infections and laboratory-based prolonged cytopenia at day 29 occurred in 12% and 37% of patients, respectively. In the posttreatment emergent reporting period (day 91 to the end of the study), which included 17 patients who were retreated with liso-cel, 23% of patients in the liso-cel–treated population (n = 249) had grade 3 or greater AEs and 17% had serious AEs.
The most common grade 3 or greater AEs in the posttreatment emergent period were neutropenia (7%), anemia (6%), thrombocytopenia (4%), and febrile neutropenia (4%). Grade 3 or greater infections occurred in 5% of patients. In the posttreatment emergent period, 100 patients (37% of all patients) died, mostly due to disease progression (86% of all posttreatment emergent deaths; 32% of all patients).
Further results demonstrated that CAR T cells were present in peripheral blood for up to 4 years.