China’s National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for JW Therapeutics’ anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product relmacabtagene autoleucel injection.
Also known as relma-cel, the product has the trade name Carteyva. It is used for 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).
This is the second approved indication for relma-cel following its initial approval and launch in September last year, and makes it the first cell immunotherapy product approved in China for the treatment of r/r FL patients.
This approval is based on the six months clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-Hodgkin lymphoma in China.
The three months data were presented at the 63rd American Society of Hematology (ASH) annual meeting in December 2021. The cohort B results showed Carteyva demonstrated very high rates of durable disease response (overall response rate (ORR)=100%, complete response rate (CRR)=85.19% at month 3; ORR=92.58%, CRR=77.78% at month 6) and controllable CAR-T associated toxicities in patients with r/r FL.
Given the currently available treatments in China, Carteyva may become a treatment option with a higher benefit-risk ratio for patients with r/r FL, and has the potential to become a best-in-class CAR-T product.
Yuqin Song, the principal investigator of RELIANCE study, deputy director of the lymphoma department, and vice president of Peking University Cancer Hospital, said: “The overall response rate (ORR) of the efficacy endpoint was over 90%, and the overall safety profile was manageable. Remal-cel has become the first CAR-T cell immunotherapy product for the treatment of the r/r FL in China.”
James Li, co-founder, chairman and CEO of JW Therapeutics, said, “Thanks to the patients and investigators who contributed to the clinical studies of Carteyva, and thanks to the regulators for the recognition of Carteyva. We are pleased with the second approved indication, which provides a new and breakthrough treatment option for r/r FL patients. JW Therapeutics is committed to maximizing the value of Carteyva, continuously advancing technology innovation and pipeline development, and improving the accessibility of cell immunotherapy products.”
As the first product of JW Therapeutics and the first CAR-T product approved as a category 1 biologics product in China, relma-cel has been approved for two indications in China.
These are for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) 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).
Currently, to fully explore the clinical potential of Carteyva, JW Therapeutics is conducting or planning to conduct more clinical studies on hematologic malignancies and autoimmune diseases, including third-line mantle cell lymphoma (MCL), third-line acute lymphoblastic leukemia (ALL), frontline and second-line large B-cell lymphoma (LBCL), and systemic lupus erythematosus (SLE).