Fosun Kat FKC889 was approved for clinical trials

On December 20, 2022, the official website of the Center for Drug Evaluation (CDE) of the State Medical Products Administration showed that, after examination, the CAR T cell therapy product FKC889 of Fosun Kat Biotechnology Company (Fosun Kat) accepted on September 21, 2022 met the relevant requirements for drug registration. Agree to carry out clinical trials of drugs for the treatment of relapsed or refractory adult precursor B-cell acute lymphoblastic leukemia (adult R/R ALL). The acceptance number is CXSL2200473 and the registration classification is 3.2 (biological products listed abroad and not listed in China shall be declared for production and listing in China) [1,2]. This is the first time that FKC889 has been approved for clinical trials in relapsed or refractory mantle cell lymphoma (R/R MCL) since March this year.

ALL is an aggressive blood tumor that can involve the lymph nodes, spleen, liver, central nervous system, and other organs. Of these, precursor B cell ALL is the most common type, accounting for 75% of ALL cases. Adult patients with R/R ALL have poor prognosis, with a median overall survival of less than 8 months [3]. The advent of CAR T cell therapy brings new hope for ALL patients.

FKC889 is a CAR T-cell therapy drug that Fosun Kite introduced from Kite (Gilead Sciences) in the United States to conduct industrialization and commercialization in China. It is also Fosun Kat's second CAR T cell therapy drug in the field of hematologic tumors. In July and December 2020, Brexucabtagene autoleucel (FKC889) received marketing approval from the US FDA and the European Food and Drug Administration, respectively, becoming the first CAR T therapy for R/R MCL adult patients [4]. Subsequently, Brexucabtagene autoleucel (FKC889) was approved by the US FDA in October 2021 and the European Food and Drug Administration in July 2022 for the treatment of R/R precursor B cell ALL[3,5].

The R/R ALL award was based on a single-arm, international multicenter, open, phase 1/2 study, ZUMA-3 (NCT02614066). From October 1, 2018 to October 9, 2019, a total of 55 patients completed the Brexucabtagene autoleucel (FKC889) transfusion. The median follow-up was 16.4 months, and 39 cases (71%; 95%CI 57-82, P < 0.0001) patients achieved complete response (CR) or complete response with hematologic incomplete recovery, with 31 (56%) achieving CR. Median response time was 12.8 months (95%CI 8.7- non-evaluable) and median overall survival was 18.2 months (95%CI 15.9- non-evaluable). Among the responding patients, median overall survival was not achieved (Figure 2), of which 38 (97%) achieved MRD negative [6].

We look forward to the early completion of clinical trials of Fosun Kat FKC889 for new indications in China, benefiting more Chinese R/R ALL patients.