AstraZeneca PLC — Imjudo EMA EPAR public assessment report (EMEA/H/C/006016, 2023)
AstraZeneca PLC · 2023 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Imjudo (tremelimumab) with durvalumab for advanced hepatocellular carcinoma (HCC) resulted in a positive CHMP opinion. The report details the drug's manufacturing, quality control, and non-clinical pharmacology, highlighting its CTLA-4 inhibition and anti-tumor activity. Non-clinical safety and pharmacokinetic studies in cynomolgus monkeys revealed adverse effects like diarrhea and immune-mediated hypothyroidism. Clinical trials, particularly the HIMALAYA study, demonstrated significant overall survival improvement and objective response rates for the combination therapy compared to sorafenib, despite a high incidence of immune-mediated adverse events. The benefit-risk balance was deemed positive, leading to marketing authorization with a required Risk Management Plan.
Key findings — cited to the page
| Grade 3 immune-mediated colitis or diarrhoea in HCC T300+D Pool | 17 (3.7%) | HIMALAYA T300+D · p.147 |
| Grade 3 immune-mediated adrenal insufficiency in HCC T300+D Pool | 1 (0.2%) | HIMALAYA T300+D · p.148 |
| Grade 5 (fatal) immune-mediated pneumonitis in HCC T300+D Pool | 1 (0.2%) | HIMALAYA T300+D · p.147 |
| Grade 5 (fatal) immune-mediated hepatitis in HCC T300+D Pool | 3 (0.6%) | HIMALAYA T300+D · p.147 |
| Grade 3 immune-mediated hyperthyroidism in HCC T300+D Pool | 1 (0.2%) | HIMALAYA T300+D · p.148 |
| Any AE of CTCAE Grade 3 or 4 (immune-mediated) in HCC T300+D pool | 62 (13.4%) | HIMALAYA T300+D · p.146 |
| Any AE of CTCAE Grade 3 or 4 (immune-mediated) in HIMALAYA T300+D arm | 51 (13.1%) | HIMALAYA T300+D · p.146 |
| Any AE of CTCAE Grade 3 or 4 (immune-mediated) in HIMALAYA S arm | 9 (2.4%) | HIMALAYA S · p.146 |
| Grade 3 immune-mediated hepatitis in HCC T300+D Pool | 20 (4.3%) | HIMALAYA T300+D · p.147 |
| Grade 4 immune-mediated hepatitis in HCC T300+D Pool | 1 (0.2%) | HIMALAYA T300+D · p.147 |
| Grade 3 immune-mediated pneumonitis in HCC T300+D Pool | 1 (0.2%) | HIMALAYA T300+D · p.147 |
| Grade 3 immune-mediated nephritis in HCC T300+D Pool | 2 (0.4%) | HIMALAYA T300+D · p.148 |
Source: AstraZeneca PLC ↗ · 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 →