AstraZeneca PLC — Imjudo EMA EPAR variation assessment report (EMEA/H/C/006016, 2023)
AstraZeneca PLC · 2023 · EMA EPAR variation assessment report · company profile →
Report summary
AstraZeneca AB's Type II variation for Imjudo (tremelimumab) to treat metastatic NSCLC in combination with durvalumab and platinum-based chemotherapy received a positive CHMP opinion. This approval is based on the pivotal POSEIDON study, a Phase III trial that investigated this regimen as first-line treatment. The study, involving 1013 patients, demonstrated significant progression-free survival, allowing for further analysis of key secondary endpoints. Pharmacokinetic data for tremelimumab and durvalumab, including dose proportionality and exposure-response relationships, supported the fixed dosing rationale and informed the recommended regimen.
Key findings — cited to the page
| Approval status | approved | durvalumab (Imfinzi) · EU · p.13 |
| Type II variation submission date | 10 March 2023 | IMJUDO · p.6 |
| CHMP opinion date | 22 June 2023 | IMJUDO · p.7 |
| Pivotal study name | POSEIDON | IMJUDO · Global · p.6 |
| POSEIDON study design | Randomized, open-label, comparative, multicenter | POSEIDON · p.12 |
| POSEIDON patient population | Patients with metastatic NSCLC who have not received prior 1L treatment, and who do not have EGFR or ALK target mutations | POSEIDON · p.12 |
| POSEIDON key outcome measures | OS, PFS, ORR, Safety: AEs, laboratory evaluations, physical examinations, and vital signs | POSEIDON · p.12 |
| POSEIDON enrollment (T + D + SoC arm) | 338 patients | POSEIDON · p.12 |
| POSEIDON enrollment (D + SoC arm) | 338 patients | POSEIDON · p.12 |
| POSEIDON enrollment (SoC arm) | 337 patients | POSEIDON · p.12 |
| IMJUDO recommended dose (NSCLC) | 75 mg | IMJUDO · p.10 |
| IMJUDO maximum doses (NSCLC) | 5 doses | IMJUDO · p.10 |
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 →