Merck B V — Bavencio EMA EPAR public assessment report (EMEA/H/C/004338, 2017)
Merck B V · 2017 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the EMA marketing authorization application for Merck's Bavencio (avelumab), an orphan medicinal product for metastatic Merkel cell carcinoma (MCC). Submitted in October 2016, it sought conditional approval due to unmet medical need, receiving a positive CHMP opinion in July 2017. The report details avelumab's physiochemical and biological characteristics, manufacturing, quality control, and stability. Non-clinical studies covered pharmacokinetics and toxicology, including repeat-dose toxicity in animals. Clinical sections describe pharmacokinetics, pharmacodynamics, and the pivotal Phase II JAVELIN Merkel 200 study (EMR100070-003), which evaluated efficacy (ORR, DOR, PFS, OS) in MCC patients. An observational study provided historical control data. A divergent opinion highlighted concerns regarding insufficient efficacy and safety data for chemotherapy-naïve patients, citing small patient numbers and immature data.
Key findings — cited to the page
| incidence of IRRs in ADA ever-positive patients | 40 % | · p.45 |
| Patients with immune-related AEs (all categories and grades, Study 003) | 17 % | EMR100070-003 · p.94 |
| Patients with immune-related AEs (all categories and grades) | 14.2 % | · p.94 |
| incidence of IRRs in ADA never-positive patients | 25 % | · p.45 |
| Patients with Grade >= 3 immune-related AEs | 2.2 % | · p.94 |
| Unconfirmed ORR (avelumab, 1L mMCC, Part B) | 60 % | EMR100070-003 Part B · p.88 |
| Confirmed ORR (avelumab, 1L mMCC, 14 patients followed for >= 6 months) | 71.4 % | EMR100070-003 Part B · p.88 |
| PFS rate at 15 months (2L chemotherapy) | 0 % | · p.87 |
| Median OS (avelumab 2L+) | 12.9 months | · p.87 |
| Median OS (chemotherapy 1L, immunocompetent patients Part A Obs-001) | 10.5 months | Study 100070OBS-001 Part A · p.87 |
| Confirmed ORR (avelumab, 1L mMCC, Part B) | 62 % | EMR100070-003 Part B · p.88 |
| Proportion of patients with at least 6 months durability of response (avelumab, 1L mMCC, Part B) | 83 % | EMR100070-003 Part B · p.88 |
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 →