NEW YORK – JW Therapeutics said on Friday its CAR T-cell therapy relmacabtagene autoleucel was approved by China's National Medical Products Administration to treat patients with relapsed or refractory large B-cell lymphoma who have received at least two prior systemic therapies.
Relmacabtagene autoleucel, or relma-cel, is the second CAR T-cell therapy to be approved in China. The approval is based on data from JW's Phase II RELIANCE trial, which included 59 patients with relapsed or refractory large B-cell lymphoma. In that study, the best overall response rate was 75.9 percent and the best complete response rate was 51.7 percent. After eight months of follow-up, the median overall survival was not reached. Six-month duration of response, progression-free survival, and overall survival rates were 60 percent, 54.2 percent, and 90.8 percent, respectively.
Relma-cel, a CD-19 targeting CAR T-cell therapy, was developed using Juno Therapeutics' CAR T-cell process platform. JW launched in 2016 as a joint venture of Juno, a Bristol Myers Squibb company, and Shanghai-based pharmaceutical firm WuXi AppTec.
JW, also based in Shanghai, has registrational studies of relma-cel ongoing in third-line follicular lymphoma and mantle cell lymphoma. The company is also exploring the CAR T-cell treatment in earlier stage studies of other blood cancers, including acute lymphoblastic leukemia, and chronic lymphocytic leukemia, and second-line diffuse large B-cell lymphoma.
In addition to relma-cel, the company is studying a BCMA-targeted CAR T-cell therapy in multiple myeloma and several agents in solid tumors.