Kite's Tecartus CAR T-cell therapy demonstrates 78% complete response rate and 90% overall response rate in largest real-world evidence analysis for relapsed/refractory mantle cell lymphoma

Kite, a Gilead Company, announces on 6 Jun 2023 findings from the largest real-world analysis to date of Tecartus (brexucabtagene autoleucel) in patients with relapsed or refractory mantle cell lymphoma (R/R MCL), which show that outcomes of Tecartus therapy had consistent high complete response (CR) and overall response rates (ORR), regardless of type of prior treatment, including: Bruton's tyrosine kinase inhibitor (BTKi), bendamustine or autologous hematopoietic cell transplant (autoHCT). Higher CR was seen when Tecartus was given as second-and-third-line compared to later lines of treatment. The data are being presented orally on 6 Jun 2023 at the 2023 American Society of Clinical Oncology Annual Meeting (ASCO) (Abstract no 7507). With median follow-up of 12 months, ORR was 90%, which was similar to ZUMA-2 results, and high CR (78%) was seen in patients who received Tecartus. Additionally, at 12 months, duration of response (DOR) (since earliest CR/partial response), progression-free survival (PFS) and overall survival (OS) rates were 64%, 61% and 74% respectively. Grade 3 or higher cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) (based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria) incidence were 10% and 28% respectively. In a multivariate analysis of patients who received Tecartus in earlier lines of therapy (1-2 vs above or equal to 3 prior lines of therapy), the data showed an ORR of 94% and a CR of 88%. The multivariate analysis assessed outcomes based on prior therapy; findings show that real-world effectiveness and safety outcomes with Tecartus in patients with R/R MCL are consistent regardless of prior treatment. In BTKi-naive patients, effectiveness (ORR 92%, CR 83%) and safety outcomes are consistent when compared with prior BTKi-treated patients. In patients with prior bendamustine use, effectiveness remained consistent and prior bendamustine use was associated with a reduced risk of grade above or equal to 3 immune effector cell-associated neurotoxicity syndrome {ICANS [odds ratio (OR) 0.50; 95% confidence interval (CI), 0.30-0.84]} and increased risk of prolonged thrombocytopenia (OR 1.98; 95% CI, 1.11-3.53). Within the multivariate analysis, PFS was improved in patients with prior autoHCT compared to those without prior autoHCT [hazard ratio (HR) 0.56; 95% CI, 0.35-0.88]. Original source: Gilead, website: http://www.gilead.com/, Copyright Gilead 2023.
research and development; anticancer drugs; bendamustine; brexucabtagene autoleucel; cell therapies; enzyme inhibitors; Tecartus; Gilead; [...]