SHANGHAI, March 8, 2023  /PRNewswire/ -- JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced the initiation of clinical study of Carteyva^® (relmacabtagene autoleucel injection) for first-line treatment in patients with high-risk large B-cell lymphoma and the first patient infusion.

High-risk large B-cell lymphoma includes large B-cell lymphoma with International Prognostic Index (IPI) score ≥3, and high-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 translocations (double-/triple-hit lymphomas; DHL/THL). Patients with high-risk large B-cell lymphoma (IPI≥3) have a low response to standard first-line chemotherapy, with complete response rate (CRR) 47.3%, 3-year overall survival (OS) rate 58.9% and progression-free survival (PFS) rate 40.7%. HGBL patients with MYC and BCL2 and/or BCL6 translocations (DHL/THL) tend to have poor prognostic indicators (e.g. bone marrow involvement, central nervous system (CNS) involvement, and elevated lactate dehydrogenase) and no recommended standard first-line therapies, with poor efficacy (CRR 59.6%) to traditional standard first-line R-CHOP chemotherapy. CRR of these patients remains <60% when treated with DA-EPOCH-R therapy and there is no significant survival benefit with the more aggressive induction regimen compared with standard R-CHOP. Therefore, there are substantial unmet clinical needs in the first-line treatment of high-risk large B-cell lymphoma patients, and new treatment options are urgently needed.

In its pivotal clinical study (RELIANCE study), Carteyva^® has demonstrated manageable safety profiles and high efficacy in patients with relapsed/refractory large B-cell lymphoma who have received at least two lines of therapies. The encouraging results have inspired CAR-T therapy destined for earlier lines of therapies in high-risk large B-cell lymphoma.

The study is an open-label, single-arm, multicenter, and investigator-initiated trial (IIT) in China, aiming to evaluate the efficacy and safety of Carteyva^® as first-line therapy in adult subjects with high-risk large B-cell lymphoma.

References

McMillan, A. K., et al. Favorable outcomes for high-risk diffuse large B-cell lymphoma (IPI 3-5) treated with front-line R-CODOX-M/R-IVAC chemotherapy: results of a phase 2 UK NCRI trial. Ann Oncol, 31(9), 1251-1259 (2020).

Ying Zhao, et al. Prognostic analysis of DLBCL patients and the role of upfront ASCT in high-intermediate and high-risk patients. Oncotarget, 8(42), 73168-73176 (2017).

China Anti-cancer Association Lymphoma Committee, et al. Clinical practice guideline for lymphoma in China (2021 Edition). Chin J Oncol, 43(7), 707-735 (2021).

Bartlett, N. L. et al. Dose-adjusted EPOCH-R compared with R-CHOP as frontline therapy for diffuse large B-cell lymphoma: clinical outcomes of the phase III Intergroup Trial Alliance/CALGB 50303. J. Clin. Oncol. 37,1790–1799 (2019).

Ying Z, et al. Relmacabtagene autoleucel (relma-cel) CD19 CAR-T therapy for adults with heavily pretreated relapsed/refractory large B-cell lymphoma in China. Cancer Med. 10(3):999-1011 (2021).

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 has been approved by the China National Medical Products Administration (NMPA) for two indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), 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, 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, and is committed to becoming an innovation leader in cell immunotherapy. Founded in 2016, JW Therapeutics has built a world-class platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and worldwide, and leading 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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