Fosun Pharma Subsidiary Fosun Kaili Submits NDA for CD19 CAR-T Therapy Brexucabtagene Autoleucel in China
Fosun Pharmaceutical
Healthcare Industry Group
Fosun Kairos
Developer of Tumor Immune Cell Therapy Technologies and Products
On September 24, the CDE website showed that Fosun Kite Biotechnology Co., Ltd., a subsidiary of Fosun Pharmaceutical,(Formerly known as Fosun Kite)TheBriacel InjectionSubmission for marketing approval. Based on the clinical trial progress of this drug, the Insight database speculates that the indication for this submission may be:Adult patients with relapsed/refractory precursor B-cell acute lymphoblastic leukemia。
Source: CDE Official Website
Brexucabtagene Autoleucel（Brexucabtagene autoleucel、KTE-X19）Developed by Kite Pharma, a subsidiary of Gilead SciencesA CAR-T Cell Therapy Targeting CD19Previously, the drug has been approved for marketing in countries and regions such as the United States, the European Union, and Canada, for the treatment of mantle cell lymphoma and B-cell acute lymphoblastic leukemia.（B-ALL）。
Fosun Kite owns the rights to Brexucabtagene Autoleucel in mainland China, Hong Kong, and Macao. It is currently conducting a single-arm Phase II clinical trial in mainland China for the treatment of mantle cell lymphoma and B-ALL with Brexucabtagene Autoleucel.
In June this year, Fosun Kite announced the latest results of the bridging registration clinical study of KTE-X19 in Chinese R/R B-ALL patients. This is a single-arm, multi-center, Phase II clinical trial.（ChiCTR2300073872）, The primary endpoint was centrally assessedCR/CR with incomplete hematologic recovery（CRi）Rate. Secondary endpoints include duration of response（DOR）, Relapse-Free Survival Period（RFS）, OS, Minimal Residual Disease（MRD）Negative Rate and Allogeneic Hematopoietic Stem Cell Transplantation（allo-SCT）Rate.
As of October 28, 2024, a total of 28 patients had received KTE-X19 reinfusion.(1×10⁶ CAR-T cells/kg)The median age of the patients was 35.5 years, 60.7% had an ECOG PS score of 1, and 35.7% were Philadelphia chromosome positive.（Ph+）, 3.6% of patients with type 2 CNS（CNS-2）Affected, 3.6% of patients had extramedullary disease. The median number of prior treatment lines was 2; 3.6% of patients had previously received blinatumomab, 14.3% had previously received inotuzumab ozogamicin, and 25% had previously undergone allo-SCT treatment.
Efficacy data shows:At a median follow-up of 8.1 months, the CR/CRi rate was 78.6%.; Median DOR, Median RFS, and Median OS were not reached,All respondents' MRD test results were negative.（100%）。
Safety data show that no new safety signals were observed in the Chinese population. Cytokine release syndrome of any grade（CRS）The incidence rate was 92.9%, including a ≥3 grade CRS incidence rate of 21.4%. Neurological events of any grade（NE）The incidence rate was 28.6%, with ≥3 grade NE occurring at a rate of 14.3%. No grade 5 CRS or NE occurred. The most common ≥3 grade adverse events were fever, decreased white blood cell count, thrombocytopenia, and decreased lymphocyte count.
Fosun Kite was established in 2017 by Fosun Pharmaceutical and Kite Pharma, a subsidiary of Gilead Sciences.In September 2024, as Fosun Pharmaceutical gained full ownership of Fosun Kite, Fosun Kite was officially renamed Fosun Kite Biotechnology Co., Ltd.Previously, Fosun Kite Biotechnology Co., Ltd. introduced CD19 CAR-T Axicabtagene Ciloleucel from Kite Pharma, which has been approved in China for the treatment of diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma.
Cover Source:Enterprise Logo
Disclaimer:This article is for information sharing only,不代表 Insight 立场和观点, and does not recommend or introduce any treatment plans. If you have any needs, please consult and contact正规医疗机构.
Editor: Xinyao
PR Article Coordination: WeChat insightxb
