ŠANGHAJ, ČÍNA, 12. decembra 2022 An independent and creative biotechnology company called JW Therapeutics (HKEX: 2126) focuses on developing, manufacturing, and selling cell immunotherapy products. At the 64th American Society of Hematology (ASH) Annual Meeting, the company 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).
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Účinnosť a bezpečnosť autoleucelu Relmacabtagene u dospelých s recidivujúcim/refraktérnym folikulárnym lymfómom v Číne (abstraktné číslo: 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 receive relma-cel at the dose level of 100×106 alebo 150 × 106 CAR T bunky, 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.
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Preliminary Safety and Efficacy of Relmacabtagene Autoleucel (relma-cel) in Adult patients with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL) in China (abstract number: 3326)
People with MCL who took part in this phase II single-arm open-label study in China got at least two types of treatment, such as anti-CD20 antibodies, anthracycline or bendamustine, and BTKis. After lymphodepleting chemotherapy, participants received relma-cel (100×106 CAR+ T cells). As of Nov 30, 2021, the preliminary data based on 11 patients provided promising clinical efficacy outcomes (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.
O lieku Relmacabtagene Autoleucel Injection (obchodný názov: Carteyva®)
Relmacabtagene autoleucel injekcia (skrátene ako relma-cel, obchodný názov: Carteyva®) is an autologous anti-CD19 CAR-T bunková imunoterapia product independently developed by JW Therapeutics based on a Bunka CAR-T 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 Produkt CAR-T schválený ako biologický produkt kategórie 1 v Číne. V súčasnosti je to jediné Produkt CAR-T v Číne ktorý bol súčasne zaradený do Národného programu vývoja významných nových liekov, prioritného preskúmania a označenia prelomovej terapie.
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O spoločnosti 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.
