JW Therapeutics Announces IND Approval for the Pivotal Clinical Trial of Carteyva® in Second-line Large B-Cell Lymphoma

SHANGHAI, March 31, 2022 /PRNewswire/ -- JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that it has received the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for a pivotal clinical trial of its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva^® (relmacabtagene autoleucel injection) in the treatment of second-line large B-Cell lymphoma.

B-cell lymphoma is a group of malignant B-cell monoclonal amplified heterogeneous malignancies, accounting for approximately 85% of non-Hodgkin lymphoma (NHL)^[1]. Large B-cell lymphoma (LBCL) is the most common subtype of NHL world-wide, accounting for 35% to 50% of all newly diagnosed cases in China^[2]. 50% of patients could be cured by current standard of care (R-CHOP) chemotherapy^[3]. Nevertheless, R-CHOP was found to be inadequate in 30% to 40% patients^[4]. R-CHOP failures were principally due to either primary refractoriness or relapse after reaching a complete response (CR), resulting in little benefit for those failure patients from conventional chemotherapy. Previous study demonstrate that for patients who could not achieve CR or maintain CR less than one year, overall response rate (ORR) of received second-line treatment was about 29%, median progression-free survival (PFS) was about 3 months, and median overall survival (OS) was about 10 months^[5]. High unmet medical needs are to be addressed for those patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) from first-line treatment.

This is a multi-centre, randomized, open label phase 3 study to compare the efficacy and safety of Carteyva^® to standard second-line therapy in adult subjects with relapse/refractory large B-cell lymphoma (r/r LBCL), not reaching CR after first-line therapies (including anthracyclines and rituximab or other CD20-targeted agents) or relapsed within 12 months of CR. Eligible adults will be randomized at the 1:1 ratio to control group and Carteyva^® group. Subjects in the control group will receive standard second-line therapy. Subjects in the Carteyva^® group will receive 100×10⁶ CAR+ T cell Carteyva^® infusion. The primary endpoint is event-free survival (EFS) assessed by Independent Review Board (IRC), and the secondary endpoints include complete response rate (CRR), PFS, OS, duration of response (DOR), pharmacokinetics, and safety.

References

1. 张慕晨;赵维莅;;B细胞淋巴瘤之治疗展望[J];中国肿瘤临床;2016年14期
2. 中华人民共和国国家卫生健康委员会，淋巴瘤诊疗规范，2018年
3. Sehn, L. H., & Gascoyne, R. D. (2015). Diffuse large B-cell lymphoma: optimizing outcome in the context of clinical and biologic heterogeneity. Blood, 125(1), 22-32. doi:10.1182/blood-2014-05-577189
4. Coiffier, B., & Sarkozy, C. e. (2016). Diffuse large B-cell lymphoma: R-CHOP failure-what to do? Hematology Am Soc Hematol Educ Program, 2016(1), 366-378.
5. van Imhoff, G. W., McMillan, A., Matasar, M. J., Radford, J., Ardeshna, K. M., Kuliczkowski, K., Hagenbeek, A. (2017). Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: The ORCHARRD Study. J Clin Oncol, 35(5), 544-551. doi:10.1200/JCO.2016.69.0198

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 JWCAR029-010 Study

This is a randomized multicenter phase 3 trial to compare the efficacy and safety of Carteyva^® to standard of care in adult subjects with high-risk, relapsed in 12 months or refractory from first-line treatment (including anthracyclines and rituximab or other CD20-targeted agents), aggressive r/r LBCL.

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.

Forward-Looking Statements

The forward-looking statements are based on the management’s expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: www.jwtherapeutics.com/en/forward-looking-statements/.

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Company Codes: HongKong:2126