Avelumab (3) – Bavencio®

Adult patients with metastatic Merkel cell carcinoma (MCC); first-line treatment

• An additional benefit is not proven for the first-line treatment of adult patients with metastatic Merkel cell carcinoma.
• Consequently, additional benefit is not proven.
• The single-arm study JAVELIN Merkel 200 submitted is, in principle, only suitable for comparing individual arms from different studies.
• For comparison with the appropriate comparator therapy, the pharmaceutical manufacturer identifies the single-arm KEYNOTE-017 study. Due to a lack of information on the study population, this study is not suitable for comparison and is excluded by the pharmaceutical manufacturer.
• Consequently, the pharmaceutical manufacturer was unable to provide suitable comparative data for the assessment of additional benefit. An assessment of additional benefit is not possible on the basis of this data.

Courtesy translation only, please refer to the German original.