SHANGHAI, CHINA, December 12, 2022 – JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, presented the latest clinical data on Carteyva® (relmacabtagene autoleucel injection) in Chinese adults with relapsed/refractory follicular lymphoma (r/r FL) and relapsed/refractory mantle cell lymphoma (r/r MCL) at the 64th American Society of Hematology (ASH) Annual Meeting.
Efficacy and Safety of Relmacabtagene Autoleucel in Adults with Relapsed/Refractory Follicular Lymphoma in China (abstract number: 4640)
In this pivotal phase II RELIANCE study, patients who had histologically confirmed grade 1, 2, or 3a FL, with r/r disease were included. Eligible patients were randomized to received relma-cel at the dose level of 100×106 or 150×106 CAR+ T cells, following lymphodepletion chemotherapy. At data cut-off (Dec 17, 2021), based on 28 patients with 11.7 months of median follow-up, relma-cel demonstrated remarkable clinical responses achieving high rates of complete response rate (CRR) and overall response rate (ORR) (6 months ORR, CRR were 100% and 83.33% respectively), and a manageable safety profile (only 1 patient experienced Gr ≥3 neurotoxicity (NT), no Gr ≥3 cytokine release syndrome (CRS)). Updated safety and efficacy data with a longer follow-up will be presented.
Preliminary Safety and Efficacy of Relmacabtagene Autoleucel (relma-cel) in Adults with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL) in China (abstract number: 3326)
In this phase II single-arm open-label study in China, participants with MCL underwent ≥2 lines of therapy including anti-CD20 antibody, anthracycline or bendamustine, and BTKis were included. After lymphodepleting chemotherapy, participants received relma-cel (100×106 CAR+ T cells). As of Nov 30, 2021, the preliminary data of relma-cel based on 11 patients provided promising clinical efficacy outcome (best ORR 81.8%, best CRR 54.5%) in high risk patients with r/r MCL and a low incidence of grade ≥ 3 CRS (1 patient) and immune effector cell-associated neurotoxicity syndrome (ICANS, 1 patient). This study is ongoing and further results will be presented.
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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.