JW Therapeutics’ Relma-Cell Approved in China for R/R Mantle Cell Lymphoma
The approved indication specifically covers adults with r/r MCL who have previously been treated with at least 2 lines of systemic therapy including BTKis.
JW Therapeutics’ relmacabtagene autoleucel injection (relma-cel; marketed as Carteyva), a marketed chimeric antigen receptor T-cell (CAR-T) therapy, has received approval of its supplemental biologics license application (sBLA) for the treatment of adults with relapsed/refractory mantle cell lymphoma (MCL) from China’s National Medical Products Administration (NMPA).1
The approved indication specifically covers adults with r/r MCL who have previously been treated with at least 2 lines of systemic therapy including bruton tyrosine kinase inhibitors (BTKis). Notably, the decision makes relma-cel the first cell therapy to be approved for the treatment of r/r MCL in China.
The sBLA that led to the NMPA’s decision for r/r MCL was supported by data from a pivotal clinical trial that took place in China. The multicenter, single-arm trial recruited patients with r/r MCL who had previously received treatment for their disease with a CD20-targeting antibody, anthracycline or bendamustine, or BTKis. In the trial, participants received a dose of 100×106 CAR+ T cells after lymphodepleting chemotherapy. Among 59 patients who were evaluable for efficacy as of the August 9, 2024, cutoff date, the best objective response rate was 81.36% and the best complete response rate was 67.80%. In terms of safety, JW noted that grade 3 or higher cases of cytokine release syndrome occurred in 6.8% of patients and that grade 3 or higher neurotoxicity also occurred in 6.8% of patients.
“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,” Sophia Yang, the senior vice president and head of regulatory, research, and development at JW Therapeutics, said in a statement.1 “Carteyva becomes the first commercial CAR T-cell product for the treatment of r/r MCL in China.”
Relma-cel, which is autologous and targets CD19, has previously been approved by the NMPA for 2 other indications: adults with r/r large B-cell lymphoma (LBCL) who have previously received at least 2 lines of systemic therapy and adults with follicular lymphoma (FL) whose disease is refractory or relapsed within 24 months of second-line or later systemic treatment. The r/r LBCL approval came in September 2021 and the r/r FL approval came in October 2022.2,3 The product has not yet been approved for any indication in the United States.
Notably, JW Therapeutics is also seeking to bring CAR-T to the treatment of autoimmune disease.4 In January 2024, the company announced an expansion of its previously existing collaboration agreement with 2seventy bio that will focus on the codevelopment and commercialization of a CAR-T therapy product intended to treat B-cell driven autoimmune diseases. Under the new agreement, JW will first focus on initial process development and conducting a first-in-human clinical trial in China, and may be eligible to receive milestone payments from 2seventy.
In addition, relma-cel itself is being evaluated for the treatment of adults with active systemic lupus erythematosus (SLE) in an investigator-initiated dose escalation study (NCT05765006) in China.5 In May 2024, JW announced preliminary clinical data from the single-arm, open-label, multicenter trial.
“Despite the recent emergence of novel biologics and therapies for SLE, many SLE patients still do not respond to available treatments, and there is currently no reliable treatment strategy to achieve drug-free remissions or even to cure the disease,” Mark J. Gilbert, MD, the chief medical officer of JW Therapeutics, said in a statement.5 “The short-term follow-up data from this study have preliminarily shown that low-dose relma-cel injection has a favorable safety profile in SLE patients, and is able to bring about deep remission, especially enabling patients to achieve low disease activity or even drug-free remission, which makes its application in the treatment of SLE a promising prospect.”
