Treatment of large B-cell lymphomas using lisocabtagene maraleucel (liso-cel) was associated with clinically meaningful activity and a low incidence of grade 3 or higher cytokine release syndrome (CRS) or neurotoxicity in the TRANSCEND NHL 001 clinical trial, the results of which were published in The Lancet

In this multicenter, seamless design study ( Identifier: NCT02631044), patients with relapsed/refractory large B-cell lymphomas received liso-cel at varying dosage levels. These levels were 50 x 106 CAR+ T cells for level 1 (45 patients), 50 x 106 CAR+ T cells in 2 doses for dosage level 1 (6 patients), 100 x 106 CAR+ T cells for level 2 (177 patients), and 150 x 106 CAR+ T cells for level 3 (41 patients). The primary study endpoints were the objective response rate, incidence of adverse events, and dose-limiting toxicities. Secondary endpoints included the number of patients who achieved a complete response, duration of response, progression-free survival, overall survival, and cellular kinetic variables.

A total of 269 patients (median age, 63 years; 65% men) received 1 or more doses of liso-cel. The median number of prior systemic therapies was 3 (interquartile range, 2-4), and chemotherapy-refractory disease was present in 67% of treated patients. In addition, 44% of patients had never achieved a complete response with previous treatment.

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Efficacy was evaluable in 256 patients. The objective response rate was 73% (95% CI, 66.8-78.0); 53% (95% CI, 46.8-59.4) of patients showed a complete response.

The level 2 dose of 100 x 106 CAR+ T cells was recommended for the dose-confirmation study phase, based on a comparison of objective response rate and low-grade CRS rates across dosage levels.

The rate of CRS was 42%, with 2% of patients having grade 3 or higher CRS. Adverse neurological events occurred in 30% of patients, with 10% of patients having grade 3 or higher neurological events. Grade 3 or worse neutropenia (60%), anemia (37%), and thrombocytopenia (27%) were the most common adverse events reported.

Dose-limiting toxicities were reported in 6% of patients. A total of 7 fatalities occurred in patients who had treatment-emergent adverse events. One of the deaths was considered related to a dose-limiting toxicity, which was diffuse alveolar damage at a level-1 dosage.

“In summary, findings of the TRANSCEND trial show that liso-cel can lead to rapid and durable remission, with low incidence of all-grade and severe cytokine release syndrome and neurological events among patients with high-risk aggressive relapsed or refractory large B-cell lymphomas,” wrote the study investigators.

Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.


Abramson JS, Palomba ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. Published online September 1, 2020. doi:10.1016/S0140-6736(20)31366-0