Long-term outcomes of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma: Updated results of the RELIANCE study

Background aims: The RELIANCE study has demonstrated the activity and safety of relmacabtagene autoleucel (relma-cel) (JW Therapeutics [Shanghai] Co, Ltd, Shanghai, China), a CD19-targeted chimeric antigen receptor T-cell product, in patients with heavily pre-treated relapsed/refractory large B-cell lymphoma (r/r LBCL). This study aimed to report the updated 2-year data of the RELIANCE study.Methods: The RELIANCE study (NCT04089215) was an open-label, multi-center, randomized, phase 1/2 registra-tional clinical trial conducted at 10 clinical sites in China. Adult patients with heavily pre-treated r/r LBCL were enrolled and received lymphodepletion chemotherapy followed by infusion of 100 x 106 or 150 x 106 relma-cel. The primary endpoint was objective response rate (ORR) at 3 months, as assessed by investigators. Secondary end-points were duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety profiles.Results: From November 2017 to January 2022, a total of 68 patients were enrolled, and 59 patients received relma-cel infusion. As of March 29, 2022, a total of 59 patients had a median follow-up of 17.9 months (range, 0.3-25.6). ORR was 77.59% (95% confidence interval [CI], 64.73-87.49) and complete response rate was 53.45% (95% CI, 39.87-66.66). Median DoR was 20.3 months (95% CI, 4.86-not reached [NR]) and median PFS was 7.0 months (95% CI, 4.76-24.15). Median OS was NR and 1-year and 2-year OS rates were 75.0% and 69.3%, respectively. Three (5.1%) patients experienced grade >= 3 cytokine release syndrome and two (3.4%) patients had grade >= 3 neurotoxicity.Conclusions: The updated data of the RELIANCE study demonstrate durable response with and manageable safety profile of relma-cel in patients with heavily pre-treated r/r LBCL.(c) 2023 Published by Elsevier Inc. on behalf of International Society for Cell & Gene Therapy.