China's First Domestic CAR-T Therapy for Leukemia, Inaticabtagene Autoleucel, Approved for Market
Juventas
Innovative Cell Therapy Drug Developer
Today (November 8), according to the information published on the official website of the National Medical Products Administration, the marketing application for the CAR-T product Nbasecarls Injection (formerly known as Hecarlson) submitted by Juventas has been approved. It is indicated for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). This is also the first CAR-T product approved in China for the treatment of acute lymphoblastic leukemia.
Public data shows that leukemia is one of the common blood tumors, with acute lymphoblastic leukemia (ALL) accounting for about 15% of all leukemia cases. Among these, B-cell acute lymphoblastic leukemia (B-ALL) makes up approximately 75% of ALL cases.Adult B-ALL patients have poorer overall survival compared to pediatric B-ALL patients.The relapse rate of adult B-ALL after initial treatment is high, with approximately 60% of patients eventually progressing to r/r B-ALL.Adult patients with r/r B-ALL have a very poor prognosis, posing a serious threat to life, and there is a lack of effective treatment options in clinical practice.To date, only two CAR-T products have been approved globally for acute lymphoblastic leukemia: Novartis' Kymriah, for pediatric and young adult patients, and Gilead's Tecartus, for adult patients.
Natio-cel Injection (CNCT19 Cell Injection, Inaticabtagene Autoleucel) is a CAR-T cell therapy product targeting CD19, featuring an innovative CD19 scFv (HI19a) structure. Its marketing application is based on a single-arm, open-label, multi-center pivotal clinical study for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. The study was led by Professor Wang Jianxiang from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, and conducted across 10 clinical centers in China. The primary endpoint was the overall response rate (ORR) at 3 months post-infusion of Natio-cel as assessed by an Independent Review Committee (IRC), including complete remission (CR) and complete remission with incomplete hematologic recovery (CRi). Secondary endpoints included ORR within 3 months, minimal residual disease negativity rate (MRD-), duration of response (DOR), relapse-free survival (RFS), and overall survival (OS).
At the 64th American Society of Hematology (ASH) Annual Meeting held in December last year, researchers disclosed relevant study data showing that, as of September 27, 2022, among 39 adult r/r B-ALL patients who received infusions of Naciorcel injection, the overall response rate (ORR) reached 82.1%. The median duration of response (DOR) had not been reached at a median follow-up of 9.3 months; among patients still responding at 3 months, it was estimated that 80% would remain in continuous remission at 1 year. Regardless of whether they subsequently underwent hematopoietic stem cell transplantation, sustained remission and long-term survival benefits were observed. In terms of safety, the incidence of Grade 3 or higher cytokine release syndrome (CRS) was 10.3%; the incidence of Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS) was 7.7%, with no unexpected adverse events related to CD19 CAR-T therapy reported.
Summary of Efficacy Data Source: Juventas
DOR Pool Chart Source: Juventas
According to another announcement on the Juventas website, the IND application for Najiolumab Injection has also been approved by the U.S. FDA, and it is proposed to be developed for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL).
As of now, four CAR-T products have been approved for marketing in China, including Juventas' Naciorlen Injection, Fosun Kite's Axicabtagene Ciloleucel Injection (CD19), Wuxi Juno's Relmacabtagene Autoleucel Injection (CD19), and IASO Biotherapeutics' Equecabtagene Autoleucel Injection (BCMA). In addition, two BCMA-targeted CAR-T therapies have submitted marketing applications to the National Medical Products Administration in China: CARsgen Therapeutics' Zevorcabtagene Autoleucel and Legend Biotech's Ciltacabtagene Autoleucel, both of which have been included in the priority review.
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