Immunocore — Kimmtrak EMA EPAR public assessment report (EMEA/H/C/004929, 2022)
Immunocore · 2022 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Kimmtrak (tebentafusp) for metastatic uveal melanoma, granted accelerated assessment due to high unmet need, confirmed its significant overall survival benefit (median 21.7 vs 16.0 months) over investigator's choice in HLA-A*02:01 positive patients. The drug's mechanism involves T-cell activation and tumor cell lysis. Manufacturing and quality control were deemed adequate. Non-clinical studies supported marketing authorization despite human-specific pharmacology. Common adverse events include skin toxicities and cytokine release syndrome, generally manageable with risk minimization strategies. The positive benefit-risk assessment led to a recommendation for marketing authorization.
Key findings — cited to the page
| irRECIST objective response rate | 9.9 % | Study 202 (Tebentafusp arm) · p.83 |
| Grade ≥3 AEs (%) | 44.5 % | Control (Investigators choice) · p.162 |
| Grade ≥3 AEs (%) | 47.6 % | Tebentafusp (All studies safety pool) · p.162 |
| patients upgraded from RECIST PD to better irRECIST outcome | 11 % | Study 202 (Tebentafusp arm) · p.83 |
| patients 'upgraded' from RECIST PD to better irRECIST outcome (tebentafusp arm) | 11% | Study 202 · p.105 |
| Patients with acute skin toxicity (Study 202, Any grade) | 119 (53.1%) | Study 202 · p.133 |
| Patients with acute skin toxicity (Study 102, Any grade) | 94 (68.6%) | Study 102 · p.133 |
| ORR according to irRECIST (tebentafusp arm) | 9.9% | Study 202 · p.105 |
| Patients with UM developing systemic metastases | 50 % | · p.9 |
| 1-year overall survival rate in mUM (meta-analysis) | 43 % | · p.10 |
| Accelerated assessment agreement date | 24 June 2021 | · p.8 |
| Marketing authorisation application submission date | 23 July 2021 | Kimmtrak · EU · p.6 |
Source: Immunocore ↗ · 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 →