The China National Medical Products Administration (NMPA) has granted market approval for inaticabtagene autoleucel (CNCT 19), an investigational cell therapy, for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (B-cell ALL) in China.
Inaticabtagene autoleucel, a CD19 CAR T-cell therapy investigational cell therapy product from the manufacturer Juventas, has a unique CD19 scFv (HI19a) structure.
The drug has demonstrated a high level of efficacy, with durable remissions, and a substantially improved safety profile with reduced CAR-T-related toxicities in a pivotal clinical study for the treatment of adults with relapsed or refractory B-cell ALL, according to a press release from CASI Pharmaceuticals, a partner of Juventas.
The approval is based on the clinical results from a single-arm, multicenter, pivotal study of 39 adult patients with relapsed or refractory B-cell ALL in China. The 9.3-month follow-up data demonstrated very high durable response, an overall response rate of 82.1%, and a complete response rate of 66.7% within three months of infusion. Median duration of response was not reached. The safety profile showed decreased severity of CAR-T-related adverse events in patients with relapsed or refractory B-cell ALL.