SHANGHAI, CHINA, June 5, 2022 - 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.
Two-year follow-up result of RELIANCE study, a multicenter phase 2 trial of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma (abstract number: 7529)
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.
About JW Therapeutics
JW Therapeutics (HKEx: 2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Founded in 2016, JW Therapeutics is committed to becoming an innovation leader in cell immunotherapy. The company has built a top world-class platform for technology and product development in cell immunotherapy, as well as a promising product pipeline covering both hematologic malignancies and solid tumors, to bring the hope of a cure for Chinese and global patients, and to lead the healthy and standardized development of China’s cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com.