Relma-cel CAR-T Therapy Approved in China for Relapsed/Refractory Mantle Cell Lymphoma
核心洞察
Relma-cel (relmacabtagene autoleucel) has been approved in China for relapsed/refractory mantle cell lymphoma (搜索) (MCL) in adults after two lines of systemic therapy.
The approval marks relma-cel as the first cell therapy approved for r/r MCL in China, based on a pivotal trial with an 81.36% objective response rate.
Grade 3 or higher cytokine release syndrome and neurotoxicity occurred in 6.8% of patients, with the treatment generally well-tolerated.
JW Therapeutics (搜索)' relmacabtagene autoleucel injection (relma-cel; marketed as Carteyva) has received approval from China’s National Medical Products Administration (NMPA) for the treatment of adults with relapsed/refractory mantle cell lymphoma (搜索) (MCL). This approval specifically targets patients who have previously undergone at least two lines of systemic therapy, including Bruton tyrosine kinase inhibitors (BTKis), marking a significant advancement in the treatment landscape for this challenging disease.
Clinical Trial Data
The approval was supported by data from a pivotal clinical trial conducted in China. This multicenter, single-arm trial included patients with r/r MCL who had prior treatment with a CD20-targeting antibody, anthracycline or bendamustine, or BTKis. Participants received a dose of 100 × 106 CAR+ T cells following lymphodepleting chemotherapy. As of the August 9, 2024, cutoff date, among 59 patients evaluable for efficacy, the best objective response rate (ORR) was 81.36%, with a best complete response (CR) rate of 67.80%.
Safety Profile
Regarding safety, the trial indicated that grade 3 or higher cases of cytokine release syndrome (CRS) occurred in 6.8% of patients, and grade 3 or higher neurotoxicity was also observed in 6.8% of patients. According to JW Therapeutics (搜索), the treatment was generally well-tolerated.
Significance of Approval
"We are delighted to have a product that can deliver meaningful efficacy in this disease; nearly 70% of patients with r/r MCL have achieved complete remission after treatment with Carteyva, and the overall safety data demonstrated that the treatment was generally well-tolerated," said Sophia Yang, the senior vice president and head of regulatory, research, and development at JW Therapeutics (搜索). "Carteyva becomes the first commercial CAR T-cell product for the treatment of r/r MCL in China."
Prior Approvals and Future Directions
Relma-cel, an autologous CAR-T therapy targeting CD19 (搜索), has previously been approved by the NMPA for adults with r/r large B-cell lymphoma (搜索) (LBCL) after at least two lines of systemic therapy (approved in September 2021) and for follicular lymphoma (搜索) (FL) refractory or relapsed within 24 months of second-line or later systemic treatment (approved in October 2022). The therapy is not yet approved in the United States.
JW Therapeutics (搜索) is also exploring the use of CAR-T therapy for autoimmune diseases. In January 2024, they expanded their collaboration with 2seventy bio to co-develop and commercialize a CAR-T therapy for B-cell-driven autoimmune diseases. JW will initially focus on process development and a first-in-human clinical trial in China.
Relma-cel is also under evaluation for adults with active systemic lupus erythematosus (搜索) (SLE) in an investigator-initiated dose-escalation study (NCT05765006) in China. Preliminary data from this trial suggests a favorable safety profile and potential for deep remission, including drug-free remission, in SLE patients, according to Mark J. Gilbert, MD, the chief medical officer of JW Therapeutics (搜索).