JW Therapeutics Announces Updated 1-year Follow-up Result of Relmacabtagene Autoleucel Injection At the 24th Annual Meeting of the Chinese Society of Clinical Oncology (CSCO)

SHANGHAI,Sept. 26,2021 --JW Therapeutics (HKEx: 2126),an innovative biotechnology company focused on developing,manufacturing and commercializing cell immunotherapy products,today announced updated 1-year follow-up result of relmacabtagene autoleucel injection (relma-cel) for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) at the 24th Annual Meeting of the Chinese Society of Clinical Oncology (CSCO).

RELIANCE Study was a phase II,open-label,single-arm,multi-center clinical study in China,which included 59 adult patients with r/r LBCL who had failed at least 2 lines of previous treatment. As of the December 31st,2020 data cut-off,in 58 evaluable patients,results include:

Relma-cel showed durable responses and long-term survival benefit; the Best Overall Response Rate was 77.6%,the Best Complete Response Rate was 51.7% and 1-year Overall Survival (OS) was 76.8% with a median follow-up of 17.9 months;

Relma-cel was generally well-tolerated with a safety profile including a low severe Cytokine Release Syndrome (≥grade 3) of 5.1% and a low severe neurotoxicity rate (≥grade 3) of 3.4%,and no new safety signals with a median of 17.9 months of follow up;

Long-term follow-up of the RELIANCE study have confirmed the durability of response and long-term OS with relma-cel treatment,which also was associated with low rates of CAR-T-associated toxicities.

"Large B-cell lymphoma (LBCL) is the most common and aggressive type of non-Hodgkin lymphoma and most patients relapse after initial therapies with limited treatment options with standard therapies and a median survival of approximately 6 months," said Mark J. Gilbert,Chief Medical Officer of JW Therapeutics,"These long-term follow-up data reported from the RELIANCE study have confirmed the durability of responses after relma-cel treatment,representing a potentially important treatment option for these patients that appears to offer clear hope of longer survival in these patients."

Reference:

Crump M,Neelapu SS,Farooq U,Van Den Neste E,Kuruvilla J,Westin J,Link BK,Hay A,Cerhan JR,Zhu L,Boussetta S,Feng L,Maurer MJ,Navale L,Wiezorek J,Go WY,Gisselbrecht C. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017 Oct 19;130(16):1800-1808. doi: 10.1182/blood-2017-03-769620. Epub 2017 Aug 3. Erratum in: Blood. 2018 Feb 1;131(5):587-588. PMID: 28774879; PMCID: PMC5649550.

About Relmacabtagene Autoleucel Injection (trade name: Carteyva®)

Relmacabtagene autoleucel injection (trade name: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy products that was independently developed by JW Therapeutics based on a CAR T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). 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 a 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 RELIANCE Study (NCT04089215)

RELIANCE study was a single-arm,multi-center,pivotal study to evaluate the efficacy and safety of relmacabtagene autoleucel injection (relma-cel) in patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) in China. At the time it was conducted,this study was the largest clinical study of CAR-T cell therapy in China under the Investigational New Drug (IND) pathway.

RELIANCE study enrolled 59 patients with r/r LBCL who had failed at least two lines of therapy,including a CD20 agent and anthracycline,and patients continue to be monitored for up to 2 years and beyond for long term outcomes. As of the December 31st,the Best Overall Response Rate was 77.6% with a Best Complete Response Rate of 51.7%,and 12-month Overall Survival (OS) was 76.8% in 58 evaluable patients; With a median follow-up of 17.9 months,of 59 treated patients,5.1% and 3.4% of the patients experienced Cytokine Release Syndrome (CRS) and Neurotoxicity (NT) of Grade 3 or above,respectively. Rates for any severity grade CRS and NT were 47.5% and 20.3%,respectively. Long term follow up of the RELIANCE study have confirmed the durability of response and long-term OS with relma-cel treatment,which also was associated with low rates of CAR-T-associated toxicities.

About JW Therapeutics

JW Therapeutics (HKEx: 2126) is an innovative biotechnology company focusing on developing,manufacturing and commercializing cell immunotherapy products. Co-founded by Juno Therapeutics (a Bristol Myers Squibb company) and WuXi AppTec 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.

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