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CAR T-Cell Therapy Yields High Response Rates in B-NHL

Relma-cel was previously approved in China in September 2021 for the treatment of B-cell non-Hodgkin lymphoma.

The chimeric antigen receptor (CAR) T-cell therapy relma-cel (JWCAR029) was well-tolerated and yielded promising response and survival rates in patients with B-cell non-Hodgkin lymphoma (B-NHL), according to new data from a phase 1 study (NCT03344367).

These data were presented at the 2022 American Society of Clinical Oncology (ASCO) meeting, held June 3-7, 2022, in Chicago, Illinois by Zhitao Ying, MD, Peking University Cancer Hospital and Insititute, Beijing, China.

“B-NHL has a very poor prognosis. Relma-cel (JWCAR029) is a CD19-targeted CAR T-cell suspension. In a phase I trial performed in November 2017 in Beijing Cancer Hospital, China, JWCAR029 was used to treat relapsed/refractory B-NHL (R/R B-NHL) in adult patients, showing a high response rate and persistent response. This report aimed to update 2-year survival data generated in the above trial,” Ying and colleagues wrote.

The study, dubbed JWCAR029-001, was an open-label, dose-escalating study. Patients with relapsed/refractory (R/R) B-NHL first received a 3-day conditioning regimen of fludarabine (25 mg/m2/day) and cyclophosphamide (250 mg/m2/day) before receiving a single, intravenous dose of relma-cel of either 25×106, 50×106, 100×106, or 150×106 CAR T cells. Two-year follow-up data were collected.

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As of January 18, 2021, 23 patients with R/R B-NHL have been enrolled and 22 have completed infusion and 2-year follow-up. Median follow-up time was 24.2 months (95% CI, 24.0-24.3). In the efficacy analysis including 20 patients, the best overall response rate (ORR) was 85.00% and the best complete response rate (CRR) was 70.00%.

Investigators performed a subgroup analysis and found that patients dosed with 100×106 cells had an ORR and CRR of 60% (n = 3/5) and a 60.0% progression free survival (PFS) rate at 1 and 2 years after infusion. The 1-year and 2-year overall survival (OS) rates in these patients were both 60.0%. Patients dosed with 150×106 cells had an ORR and CRR of 62.5% (n = 5/8) and a 62.5% PFS rate at 1 and 2 years.The 1-year and 2-year overall survival (OS) rates in these patients were both 75.0%.

Overall, the 1-year and 2-year PFS rates with 11 patients censored were both 55.0% and median PFS was not reached. The 1-year and 2-year OS rates with 3 patients censored were both 68.6% and median OS was not reached. Six deaths (30%) occurred and investigators did not observe any grade 3 and above cytokine release syndrome or neurotoxicity.

Relma-cel was approved in China in September 2021 based off the results of the phase 2 RELIANCE study (NCT04089215) that demonstrated the CAR T-cell therapy’s efficacy and tolerable toxicity in B-NHL.

“This report indicated that R/R B-NHL cases could benefit from JWCAR029. R/R B-NHL cases administered JWCAR029 at 100×106 or 150×106 cells had a promising response rate, with durable PFS and sustained OS benefits after 12 months. The effectiveness and safety of JWCAR029 need to be confirmed in the real-world setting,” Ying and colleagues wrote.

REFERENCE
Ying Z, Song Y, Zhu J. Relma-cel (JWCAR029) in relapsed and refractory B-cell non-Hodgkin lymphoma: A two-year survival update of a phase I study. Presented at: 2022 ASCO Meeting, June 3-7; Chicago, IL. Abstract # e19555