JW (Cayman) Therapeutics Co. Ltd. presented the latest clinical data on Carteyva ® (relmacabtagene autoleucel injection) ("relma-cel", trade name: Carteyva®) 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 Annual Meeting. 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 or 150×106 chimeric antigen receptor T ("CAR-T") cells, following lymphodepletion chemotherapy. As of the data cut-off date of December 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, no Gr 3 cytokine release syndrome ("CRS")). Updated safety and efficacy data with a longer follow- up will be presented.

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 BTKi were included. After lymphodepleting chemotherapy, participants received relma-cel (100×106 CAR-T cells). As of November 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. 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 Inc. (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel has been approved by the China National Medical Products Administration for two indications, including the treatment of adult patients with r/r 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, making relma-cel (Carteyva®) the first CAR-T product approved as a Category 1 biologics product in China.

Currently, relma-cel (Carteyva®) 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.