Gilead Sciences, Inc. — Tecartus EMA EPAR public assessment report (EMEA/H/C/005102, 2020)
Gilead Sciences, Inc. · 2020 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Tecartus (KTE-X19) for relapsed/refractory mantle cell lymphoma (MCL). Tecartus, an autologous anti-CD19 CAR T-cell therapy, received conditional marketing authorization based on promising ZUMA-2 trial data showing high objective and complete response rates. The report details its manufacturing, non-clinical safety, and pharmacokinetic profiles, noting challenges in animal models and environmental risk. Clinical efficacy and safety from ZUMA-2 (82 patients) revealed high incidences of cytokine release syndrome (91%) and neurological adverse events (68%), consistent with CAR T-cell therapies. Despite these, the benefit-risk balance was deemed positive, necessitating post-authorization studies for long-term efficacy and safety, and a robust risk management plan.
Key findings — cited to the page
| patients with worst Grade 3 or higher AEs (ZUMA-2 Cohort 2) | 93 % | ZUMA-2 · p.98 |
| encephalopathy (Grade 3 or higher) (ZUMA-2 Cohort 1) | 18 % | ZUMA-2 · p.99 |
| worst Grade 3 CRS (ZUMA-2 Cohort 1) | 12 % | ZUMA-2 · p.98 |
| worst Grade 4 neurologic event (ZUMA-2 Cohort 1) | 9 % | ZUMA-2 · p.98 |
| worst Grade 3 neurologic events (ZUMA-2 Cohort 2) | 43 % | ZUMA-2 · p.98 |
| worst Grade 1 or 2 CRS (ZUMA-2 Cohort 1) | 76 % | ZUMA-2 · p.98 |
| patients with worst grade 5 AE (ZUMA-2 combined cohorts) | 7 % | ZUMA-2 · p.91 |
| patients with worst Grade 3 or higher AEs (ZUMA-2 Cohort 1) | 99 % | ZUMA-2 · p.98 |
| worst Grade 4 CRS (ZUMA-2 Cohort 1) | 3 % | ZUMA-2 · p.98 |
| worst Grade 3 neurologic event (ZUMA-2 Cohort 1) | 22 % | ZUMA-2 · p.98 |
| worst Grade 3 CRS (ZUMA-2 Cohort 2) | 14 % | ZUMA-2 · p.98 |
| confusional state (Grade 3 or higher) (ZUMA-2 Cohort 1) | 12 % | ZUMA-2 · p.99 |
Source: Gilead Sciences, Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →