JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, presented the latest data of three clinical studies on Carteyva^® (relmacabtagene autoleucel injection, hereafter abbreviated as relma-cel) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, including a two-year follow-up result of RELIANCE study, a multicenter phase 2 trial of Carteyva^® in Chinese patients with relapsed/refractory large B-cell lymphoma, preliminary safety and efficacy of Carteyva^® as second-line therapy for primary refractory Chinese patients with large B-cell lymphoma (LBCL) from an open-label, multicenter, single-arm phase I study, and a two-year survival update of a phase I study of Carteyva^® in relapsed and refractory B-cell non-Hodgkin lymphoma.

RELIANCE study was the first pivotal CD19 CAR-T study received IND approval by NMPA. A total of 59 patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL) received single infusion of relma-cel, and completed 2-year follow-up. Results include:

• Relma-cel demonstrated sustained response and long-term survival benefit. Among the 58 efficacy evaluable patients, best overall response rate (ORR) and complete response rate (CRR) were 77.6% and 53.5%, respectively. 2-year overall survival (OS) rate was 69.0%.
• Relma-cel showed a manageable safety profile with relatively low rate of cytokine release syndrome (CRS) and neurotoxicity (NT). The incidence of CRS of any grade and Grade≥3 were 47.5%, 5.1%, respectively. The incidence of NT of any grade and Grade≥3 were 20.3%, 3.4%, respectively. The most common Grade≥3 adverse events (AEs) were neutropenia and leukopenia.
• 2-year follow-up data of RELIANCE study showed that relma-cel delivered sustained response and long-term survival with a manageable safety profile and a relatively low incidence of CAR-T related toxicity.

Preliminary safety and efficacy of relmacabtagene autoleucel (relma-cel) as second-line therapy for primary refractory Chinese patients with large B-cell lymphoma (LBCL): Results from an open-label, multicenter, single-arm phase I study (abstract number: e19509)

This was an open-label, single-arm, multi-centre, phase I study, aiming to evaluate the safety and efficacy of relma-cel in patients with primary refractory disease after first-line standard of care (R-CHOP). A total of 12 patients received relma-cel infusion and completed 9 months follow-up.

Data showed relma-cel was tolerable. No Grade≥3 CRS or NT was observed. 6 patients had Grade ≤2 CRS, and 2 patients experienced NT (Grade 1). The most common treatment related Grade≥3 treatment emergent adverse events (TEAEs) was cytopenia.

The best ORR and CRR were 75.0% and 33.3%, 3-month ORR and CRR were 41.7% and 33.3%, respectively. Median duration of response (DOR) and OS were not yet reached.

Relma-cel (JWCAR029) in relapsed and refractory B-cell non-Hodgkin lymphoma: A two-year survival update of a phase I study (abstract number: e19555)

This was an open-label, dose-escalating phase I study of relma-cel for relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL). A total of 22 patients with r/r B-NHL received single dose of relma-cel and completed 2-year follow-up.

Based on the efficacy analysis set comprising 20 patients, the best ORR and CRR were 85.00% and 70.00%, respectively. The progression-free survival (PFS) rates of 1-year and 2-year were both 55.0%, and the OS rates were both 68.6%. Neither median PFS nor median OS was reached. No grade 3 and above CRS or NT were found.

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About Relmacabtagene Autoleucel Injection (trade name: Carteyva^®)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva^®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations