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
This report summarizes a Type II variation assessment for Imfinzi (durvalumab) and Imjudo (tremelimumab), incorporating pediatric data from study D419EC00001. The study evaluated safety, tolerability, and preliminary efficacy of durvalumab monotherapy or in combination with tremelimumab in pediatric patients with advanced solid tumors and hematological malignancies. Pharmacokinetic (PK) analysis revealed body weight influenced drug exposure, with lower weight reducing tremelimumab exposure. While PK data informed optimal pediatric dosing to match adult exposures, efficacy results were negative, and no pediatric indication is sought. Safety profiles were consistent with known adult data, with no new concerns identified, though Grade 3/4 adverse events occurred. Immunogenicity was also assessed, confirming CD4+Ki67+ T-cell activation with combination therapy.
Key findings — cited to the page
| Patients with Grade 3 or Grade 4 AEs in D20+T1 group (dose-finding) | 4/10 (40.0%) | Study D419EC00001 · p.78 |
| Patients with Grade 3 or Grade 4 AEs in SARCOMA cohort (dose-expansion) | 5/11 (45.5%) | Study D419EC00001 · p.79 |
| Patients with Grade 3 or Grade 4 AEs in D30+T1 group (dose-finding) | 6/19 (31.6%) | Study D419EC00001 · p.78 |
| Patients with Grade 3 or Grade 4 AEs in STO cohort (dose-expansion) | 5/10 (50.0%) | Study D419EC00001 · p.80 |
| Disease Control Rate (DCR) in STO cohort | 11.1% | D419EC00001 · p.5 |
| median Progression-Free Survival (PFS) in STO cohort | 1.7 months | D419EC00001 · p.5 |
| median Overall Survival (OS) in SARCOMA cohort | 6.6 months | D419EC00001 · p.5 |
| Application type | Type II variation | Imfinzi & Imjudo · p.4 |
| Duration of Response (DoR) for chordoma patient | 10.8 months | D419EC00001 · p.5 |
| Study phase | Phase I/II | D419EC00001 · p.4 |
| Number of patients | 50 patients | D419EC00001 · p.9 |
| Objective Response Rate (ORR) | 5.0% | D419EC00001 · p.5 |
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 →