JW Therapeutics Announces Initiation of Clinical Study of Carteyva® in First-line Treatment in Patients with High-Risk Large B-Cell Lymphoma
SHANGHAI,March 8,2023 -- 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,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
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