China's National Medical Products Administration (NMPA) has approved the supplemental biological licence application (sBLA) for JW Therapeutics’ Carteyva for relapsed or refractory mantle cell lymphoma (r/r MCL) in adults.
MCL, a heterogeneous B cell non-Hodgkin lymphoma, has a poor prognosis and mainly occurs in elderly men who receive a diagnosis at the disease’s advanced stages.
The sBLA for Carteyva, an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy, was supported by results from a multi-centre clinical study in China.
Out of 59 evaluable patients in the study who received Carteyva (100×106 CAR+ T cells), an objective response rate (ORR) of 81.36% and a complete response rate (CRR) of 67.80% was achieved.
The study results also revealed severe (grade ≥ 3) cytokine release syndrome (CRS) incidence at 6.8% and severe (grade ≥ 3) neurotoxicity incidence at 6.8%.
JW Therapeutics senior vice president and head of regulatory, research & development, Sophia Yang, commented: "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.”
China is dominating the global development of CAR-T cell therapies by a considerable margin. Research in 2023 by GlobalData found the country led with the highest percentage of CAR-T trials at 55.3%, followed by the US at 26.9%, Germany at 3.1%, Spain at 3.0%, and France at 2.9%.
GlobalData is the parent company of Clinical Trials Arena.
According to GlobalData analysts, the high number of trials in China may be due to government initiatives to ensure new treatments come to market. The nation’s healthcare initiative, Healthy China 2030, is thought to be an additional driver of CAR-T therapy drug development.
GlobalData’s Pipeline Drugs database indicates that JW Therapeutics has 11 drugs in its pipeline, including relmacabtagene autoleucel in Phase II development for haematoma, systemic lupus erythematosus, and leukaemia.
The company recently presented preliminary clinical data on its relmacabtagene autoleucel (relma-cel) injection in adults with active systemic lupus erythematosus at the 2024 European Alliance of Associations for Rheumatology Congress in Vienna.
The company said the preliminary data showed that relma-cel could induce ‘profound and lasting’ remissions in patients with moderate to severe SLE while maintaining a favourable safety profile.
In related news, AstraZeneca recently reported positive data from its ECHO Phase III MCL trial. The pharma giant’s research demonstrated that its Calquence combination therapy (acalabrutinib) significantly improved progression-free survival in patients with untreated MCL.
Galapagos recently had its investigational new drug (IND) application approved by the US Food and Drug Administration, providing clearance for the company to commence the Phase I/II ATALANTA-1 study of GLPG5101 for relapsed/refractory non-Hodgkin lymphoma (r/r NHL).
