Merck B V — Bavencio EMA EPAR variation assessment report (EMEA/H/C/004338, 2017)
Merck B V · 2017 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the assessment of pediatric studies for Bavencio (avelumab) as per EU regulations. A Phase I/II study (MS100070-0306) investigating avelumab in pediatric patients with refractory or relapsed solid tumors and lymphoma was conducted. The Phase II portion was terminated due to a lack of objective responses to avelumab monotherapy. While no new safety concerns were identified and the maximum tolerated dose was not reached, neither the 10 mg/kg nor 20 mg/kg dose groups demonstrated objective responses.
Key findings — cited to the page
| Grade ≥ 3 TEAEs (10 mg/kg group) | 83.3 % | MS100070-0306 · p.11 |
| Grade ≥ 3 TEAEs (20 mg/kg group) | 73.3 % | MS100070-0306 · p.11 |
| objective response rate (ORR) 95% CI | 0.0, 21.8 % | MS100070-0306 · p.11 |
| study type | multicenter, open-label, international, Phase I/II study | MS100070-0306 · p.3 |
| enrolment N | 6 subjects | MS100070-0306 · p.6 |
| age range | 0 to < 18 years years | MS100070-0306 · p.3 |
| primary tumour categories | soft tissue/bone sarcoma (12 subjects [57.1%]), CNS (8 subjects [38.1%]), and GI (1 subject [4.8%]) | MS100070-0306 · p.7 |
| median age | 12 years | MS100070-0306 · p.7 |
| objective response rate (ORR) | 0 % | MS100070-0306 · p.11 |
| best overall response (BOR) of stable disease (SD) | 26.7 % | MS100070-0306 · p.11 |
| treatment-emergent adverse events (TEAEs) | 100.0 % | MS100070-0306 · p.11 |
| enrolment N | 15 subjects | MS100070-0306 · p.6 |
Source: Merck B V ↗ · 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 →