SHANGHAI, Dec. 7, 2020 /PRNewswire/ -- JW Therapeutics (stock code: 2126.HK), a leading clinical stage cell therapy company, presented data from the pivotal study (RELIANCE Trial) of relmacabtagene autoleucel ("relma-cel") under IND pathway at the 62nd American Society of Hematology (ASH) Annual Meeting, taking place virtually December 5th – 8th, 2020.
The RELIANCE Trial was the first study of a CAR-T therapy manufactured in China for the treatment of patients with relapsed or refractory ("r/r") B-cell lymphoma in China. Compared with other anti-CD19 CAR-T therapies approved in the US and EU, relma-cel shows similar efficacy and pharmacokinetic profiles while providing the potential for an improved toxicity profile in heavily-pre-treated patients with r/r LBCL of poor risk features.
Dr. James Li, Co-Founder, Chairman and CEO of JW Therapeutics commented: "The presentation reinforced relma-cel's significant competitive advantage in the CAR-T market in China, highlighting its competitive efficacy and safety profiles. We are confident that these data will provide strong support to relma-cel's ongoing New Drug Application (NDA) in China and we look forward to bringing this innovative CAR-T therapy to patients as soon as possible."
Summary of Pivotal Study Data of Relma-cel
In JWCAR029 pivotal study (RELIANCE Trial), 69 patients were screened, and 59 with r/r large B cell lymphoma were enrolled and treated with relma-cel, with median age of 56.0 years (18-75). The median doses administered in low and high dose groups were 99.7×106 (range, 80.1-101.3) and 150.0×106 (range, 120.0-156.4) CAR+ T cells, respectively.
As of June 17, 2020 data cut-off, Best Overall Response Rate was 75.9% (95% CI, 62.8- 86.1) with Best Complete Response Rate of 51.7% (95% CI, 38.2-65.1) in 58 evaluable patients. With a median follow-up of 8.9 months, median OS were not reached, and 6 month DOR, PFS and OS were 60.0%, 54.2% and 90.8%, respectively.
Of 59 treated patients, 28 patients (47.5%) experienced CRS of any grade. Grade 3 and 4 CRS was observed in 2 patients (3.4%) and 1 patient (1.7%), respectively. The median onset of CRS was at 4.5 days (range 1 to 5) after infusion with a median duration of 7.0 days (range 1 to 18). Neurologic events occurred in 12 patients, with only 3 (5.1%) having severe grade events (all Grade 3). Median onset of NT was at 8.5 days after infusion, with a median duration of 12.5 days (range 1 to 49). CRS and NT were generally manageable and all cases resolved except one patient who died at day 8 of sepsis and ongoing grade 4 CRS.
The RELIANCE Trial provided the first demonstration of licensure-quality CAR-T manufacturing and clinical trial data generation in r/r patients originating in China. These results with relma-cel demonstrate similar preliminary response rates while providing the potential for an improved toxicity profile in heavily-pre-treated patients with r/r LBCL having poor risk features relative to other CD19-specific CAR-Ts approved in the US and EU.
About Relmacabtagene autoleucel ("relma-cel")
Relmacabtagene autoleucel ("relma-cel"), JW Therapeutics' lead product, is an anti-CD19 CAR-T therapy for third-line treatment for relapsed or refractory ("r/r") B-cell lymphoma. The New Drug Application (NDA) for relma-cel as a third-line treatment for diffuse large B-cell lymphoma ("DLBCL") was accepted for review by China's National Medical Products Administration ("NMPA") in June 2020 and was granted priority review status in September 2020. Moreover, the NMPA also granted Breakthrough Therapy Designation for relma-cel as a treatment for follicular lymphoma. Relma-cel is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.
About JW Therapeutics
Co-founded by Juno Therapeutics and Wuxi AppTec, JW Therapeutics is a leading clinical and pre-clinical stage cell therapy company in China with an integrated platform focusing on developing, manufacturing and commercializing breakthrough cell-based immunotherapies for hematological cancers and solid tumors.
JW Therapeutics' vision is to develop innovative cell therapies for the China market to transform the treatment of cancer for Chinese patients. The company has built a comprehensive and differentiated cell therapy pipeline covering both hematological cancers and solid tumors. Its lead product, Relmacabtagene autoleucel ("relma-cel"), an anti-CD19 CAR-T therapy for relapsed or refractory ("r/r") B-cell lymphoma, is expected to be the first CAR-T therapy to be approved as a Category 1 biologics product in China.
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Cautionary Statement required by Rule 18A.05 of the Rules Governing the Listing of Securities of Stock Exchange of Hong Kong Limited: JW Therapeutics cannot guarantee that it will be able to develop, or ultimately market Relmacabtagene autoleucel ("relma-cel") successfully. Shareholders and potential investors of JW Therapeutics are advised to exercise due care when dealing in the shares of JW Therapeutics.