Nov. 8, 2023，China's National Medical Product Administration (NMPA) has approved its New Drug Application (NDA) for Inaticabtagene Autoleucel (CNCT19 Injection), a CD19-targeted autologous chimeric antigen receptor (CAR)-T cell therapy for adult relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).Inaticabtagene Autoleucel will potentially be best-in-class CAR-T cell therapy for adult r/r B-ALL, meeting long-seeking unmet clinical need.
Inaticabtagene Autoleucel is a CD19 CAR-T cell therapy product, featured with a unique CD19 scFv（HI19a）and advanced manufacturing processes. The pivotal study of Inaticabtagene Autoleucel has demonstrated high efficacy, durable remission, and substantially improved safety profile with adult r/r B-ALL.Inaticabtagene Autoleucel is the first proprietary CD19-targeted CAR-T product invented in China, and the first commercialized CAR-T cell therapy product for B-ALL in China .
This approval is based on the clinical results from a single-arm, multi-center, pivotal study of 39 adult patients with r/r B-ALL in China （NCT04684147）. The 9.3-month follow up data demonstrated very high durable response, overall response rate (ORR): 82.1%, complete response rate (CR): 66.7% within 3 month after infusion and median duration of response (DoR) has not reached. The safety profile showed the decreased severity of CAR T-Cell related adverse events in patients with r/r B-ALL.
On September 26, 2024,China's National Medical Product Administration (NMPA) has accepted its New Drug Application (NDA) for Inaticabtagene Autoleucel (CNCT19 Injection), a CD19-targeted autologous chimeric antigen receptor (CAR)-T cell therapy, for relapsed and refractory Relapsed or Refractory Large B-Cell Lymphoma (r/r LBCL) treatment.
Non-Hodgkin's lymphoma (NHL) is a group of malignant tumors of the lympho-hematopoietic system, with incidence rates rising year by year. Diffuse large B-cell lymphoma (DLBCL) is the most common subtype, accounting for 25% to 50% of NHL cases. DLBCL is aggressive disease with a high level of heterogeneity, 30% to 40% of DLBCL patients experience relapse or refractory events following first-line treatment. Once proceeded to relapse or refractory status, the disease progress is rapidly accelerated, with a median survival time of only 6.3 months, posing a significant challenge for more effective treatments.
In the Phase I/II clinical trial (NCT04690192),Combinational therapy of CAR T-cell and HDT/ASCT demonstrates impressive clinical efficacy.A total of 25 patients with R/R LBCL were enrolled in this study. The overall response and complete response rates were 92.0% and 72.0%, respectively. The 2-year progression-free survival rate was 62.3%, and the overall survival was 68.5% after a median follow-up of 27.0 months. No unexpected toxicities were observed. All cases of cytokine release syndrome were of low grade. Two cases (8%) experienced grade 3 or higher CAR T-cell-related encephalopathy syndrome. The comparison of CNCT19 in vivo behavior showed that patients in the combinational therapy group exhibited enhanced in vivo expansion of CNCT19 cells and reduced long-term exhaustion formation, as opposed to those receiving CNCT19 monotherapy.
At present, there are many other CAR-T clinical trials in China, and they are looking for patients. For consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department: 4008803716.
References
1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20231108092415187.html
2.http://www.juventas.cn/news.php?id=654
3.https://www.news.cn/health/20231113/936ed7e5f1114d8e8eba962ac59b539c/c.html
4.http://www.juventas.cn/news.php?id=627
5.https://jitc.bmj.com/content/12/4/e008857.long