Chimeric antigen receptor (CAR) T-cell therapy for multiple myeloma is not yet available in China. However, the China National Medical Products Administration (NMPA) has recently accepted the new drug application (NDA) for Innovent and IASO Biotherapeutics’ CAR-T therapy equecabtagene autoleucel to treat relapsed and/or refractory multiple myeloma (R/R MM). Following the approval, it will be the first homegrown CAR-T therapy for multiple myeloma patients and potentially the first approved CAR-T therapy for multiple myeloma in China, says GlobalData, a leading data and analytics company.

Equecabtagene autoleucel is a fully human anti-B cell maturation antigen (BCMA) CAR-T therapy, a high anticipated class in multiple myeloma. These agents hold great promise in heavily pretreated patients, who do not respond to the currently available treatment options. The use of the currently approved therapies in combination regimens in earlier treatment lines is another factor that limits treatment options and their efficacy in heavily pretreated patients.

Prashant Khadayate, Pharma Analyst at GlobalData, comments: “Despite advances in treatment, multiple myeloma remains an incurable disease characterized by periods of remission and relapse. Unfortunately, most patients experience a relapse following initial therapies, and the duration of response as well as survival outcomes decreases with each successive treatment.”

CAR-T therapies for multiple myeloma patients are already approved in the US and Europe and include Abecma (idecabtagene vicleucel) from Bristol Myers Squibb and Carvykti (ciltacabtagene autoleucel) from Janssen.

According to GlobalData’s Pharmaceutical Intelligence Center, 23 CAR-T candidates are in Phase I and II development in China for multiple myeloma, as of 19 June 2022.

Khadayate concludes: “CAR-T therapies face challenges in terms of therapy preparation time, high treatment cost, and side effects. However, equecabtagene autoleucel will get the first mover advantage and its inclusion in the National Reimbursement Drug List (NRDL) will increase uptake and improve affordability.

“Currently, domestic players dominate the multiple myeloma CAR-T therapy pipeline in China. Predominantly, CAR-T therapies receive approval based on Phase II data. Considering the potential pipeline in Phase II in China, GlobalData expects more CAR-T therapy options for multiple myeloma patients in the near future, which will undoubtedly make CAR-T therapies more competitive in terms of pricing.”