Avelumab
Trade name: Bavencio. ATC L01FF04.
Avelumab is a fully human IgG1 monoclonal antibody against PD-L1. Its primary skin oncology role is as first-line treatment for untreated metastatic Merkel cell carcinoma (NICE TA691), where the larger JAVELIN Merkel 200 first-line cohort showed an objective response rate of about 40%, with durable responses in responders. As an IgG1 antibody (vs IgG4 for pembrolizumab and nivolumab) it can engage Fc receptors and may have additional antibody-dependent cellular cytotoxicity.
Indications (UK)
- Untreated metastatic Merkel cell carcinoma — first-line, NICE TA691 (2021).
Dosing
- 800 mg IV every 2 weeks.
- Premedicate with paracetamol and antihistamine for first 4 infusions (infusion-related reactions are commoner with avelumab than pembrolizumab/nivolumab).
- Continue until disease progression or unacceptable toxicity.
Response
JAVELIN Merkel 200 trial: objective response rate ~33% in chemotherapy-pre-treated patients; about 40% in the larger treatment-naïve cohort (the early interim first-line analysis reported a higher estimate in a small cohort). Median duration of response not reached in key analyses; many durable responses extend beyond 3 years. Outcomes are notably better in immunocompetent patients than in immunosuppressed.
Adverse events
Two distinct profiles: immune-related adverse events (similar to other ICI — see pembrolizumab) and infusion-related reactions.
Infusion-related reactions
- ~25% in pivotal studies; mostly grade 1–2.
- Premedicate first 4 infusions; observe during and after.
- Slow infusion or stop / re-challenge for grade 1–2; permanently discontinue grade 3–4.
Practical considerations
- Baseline as for other ICI: FBC, U&E, LFT, TFT, glucose, cortisol, CK; pregnancy test.
- Discuss with transplant team in OTRs (graft-rejection risk).
- Pembrolizumab has phase 2 evidence in advanced MCC (KEYNOTE-017), but no NICE pembrolizumab MCC TA was identified on live checking; confirm any local or national access route before use.
References
- Kaufman HL et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma (JAVELIN Merkel 200). Lancet Oncol; 2016.
- D'Angelo SP et al. First-line avelumab in a cohort of 116 patients with metastatic Merkel cell carcinoma. Ann Oncol; 2021.
- NICE TA691. Avelumab for untreated metastatic Merkel cell carcinoma. London: NICE; 2021.
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