Tecartus

Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. The drug received conditional marketing authorization. In the ZUMA-2 study, after failing BTK inhibitors, Tecartus demonstrated an overall response rate (ORR) of 86% and a complete response (CR) rate of 54%. The estimated 9-month duration of response (DoR) rate was 69.9%, and the estimated 9-month overall survival (OS) rate was 83.7%. For patients who progressed after chemotherapy and targeted agents, the median OS was 10 to 13 months. In comparison, the ORR for BTK inhibitors in the relapsed setting was 68%, and for ibrutinib in r/r MCL across three studies, the ORR was 70% with CR rates of 27%. The median OS after failure of BTK inhibitors was 2.9 to 5.8 months.

Notable safety findings include treatment-related mortality rates following allo-SCT of up to 40%. In Cohort 1 (KTE-X19), 16 deaths were reported, representing 24% of the cohort. The commercial dose acceptance criteria for Tecartus are 1.0x10^6 – 2.0x10^6 anti-CD19 CAR viable T-cells/kg, with a maximum allowable dose of 2.0x10^8 anti-CD19 CAR viable T-cells. The regulatory status is conditional approval, with follow-up data submission for ZUMA-2 required at 24 months.