Abstract
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 registrational 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 × 106 or 150 × 106 relma-cel. The primary endpoint was objective response rate (ORR) at 3 months, as
assessed by investigators. Secondary endpoints 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.
Key Words
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Article info
Publication history
Published online: February 24, 2023
Accepted:
October 27,
2022
Received:
July 1,
2022
Publication stage
In Press Corrected ProofIdentification
Copyright
© 2023 Published by Elsevier Inc. on behalf of International Society for Cell & Gene Therapy.
