Anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy lisocabtagene maraleucel (liso-cel) appeared to have durable clinical benefit in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), according to follow-up data from the phase 1 TRANSCEND NHL 001 trial (ClinicalTrials.gov Identifier: NCT02631044). The trial results were presented at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida.1
Among the 342 patients who underwent leukapheresis, 268 were infused with liso-cel at 1 of 3 dose levels (50×106, 100×106, or 150×106 CAR-T cells). The manufacturing process took a median of 24 days, and 25 patients were infused with liso-cel in the outpatient setting.
According to the study researchers, the outcomes among the 3 dose levels were “similar” and therefore the data were pooled. A total of 255 patients were included in the efficacy analyses.
Overall, 73% of patients responded and 53% had a complete response (CR). At 10.8 months of follow-up, patients had a median duration of response (DOR) of 13.3 months (95% CI, 8.2‒not reached [NR]), and for patients who achieved a CR, the median DOR has not yet been reached. Patients had a median progression-free survival (PFS) of 6.8 months (95% CI, 3.3‒11.8) and a median overall survival of 19.9 months (95% CI, 10.9‒NR).
Cytokine release syndrome (CRS) of any grade was seen in 42% of patients; 2% of patients had grade 3 or higher CRS. In addition, 30% of patients had neurological events of any grade; 10% had grade 3 or higher neurological events.
Grade 3 or higher treatment-related adverse events (TRAEs) were seen in 79% of patients, and the events were mostly cytopenias. In fact, 37% of patients had prolonged grade 3 or higher cytopenia. A total of 4 patients died from adverse events that were determined to be related to treatment with liso-cel and lymphodepletion.
“Longer-term follow-up from the TRANSCEND study shows that liso-cel resulted in a rapid, high rate of durable complete responses with low incidence of severe cytokine release syndrome and neurologic events,” lead study author Jeremy Abramson, MD, associate professor of medicine at Harvard Medical School and director of the Lymphoma Center at Massachusetts General Hospital, said in a press release.2
Disclosure: Some of the abstract authors disclosed financial arrangements with pharmaceutical companies. For a full list of disclosures, please refer to the original abstract.
- Abramson JS, Palomba ML, Gordon LI, et al. Pivotal safety and efficacy results from Transcend NHL 001, a multicenter phase 1 study of lisocabtagene maraleucel (liso-cel) in relapsed/refractory (R/R) large B cell lymphomas. Presented at: 61st American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2019; Orlando, FL. Abstract 241.
- Bristol-Myers Squibb. Bristol-Myers Squibb announces liso-cel met primary and secondary endpoints in TRANSCEND NHL 001 study [press release]. Princeton, NJ: Bristol-Myers Squibb. Published December 7, 2019. Accessed December 17, 2019.