Fostering the first FDA-approved drug for Merkel cell carcinoma



Merkel cell carcinoma is a very rare disease in which cancer cells form in the skin. Merkel cell carcinoma tends to grow quickly and metastasize at an early stage. Prior to 2017, no FDA-approved treatment existed for this disease.


IRP investigators, in collaboration with EMD Serono, Inc., developed and tested avelumab, an immunotherapy drug that targets the protein programmed death-ligand 1 (PD-L1), as a treatment for Merkel cell carcinoma. The team’s preclinical research demonstrated that avelumab allows T cells to efficiently kill a variety of tumor cells. Based on these findings, the team launched the first-in-human trials of avelumab that established safety and pharmacokinetic data on the drug. Based on these results, a multicenter clinical trial was initiated, which included the IRP, and successfully demonstrated the use of avelumab in metastatic Merkel cell carcinoma patients.


In 2017, the U.S. Food and Drug Administration approved avelumab for adults and patients 12 years of age and older with metastatic Merkel cell carcinoma.


Heery CR, O'Sullivan-Coyne G, Madan RA, Cordes L, Rajan A, Rauckhorst M, Lamping E, Oyelakin I, Marté JL, Lepone LM, Donahue RN, Grenga I, Cuillerot JM, Neuteboom B, Heydebreck AV, Chin K, Schlom J, Gulley JL. (2017). Avelumab for metastatic or locally advanced previously treated solid tumours (JAVELIN Solid Tumor): a phase 1a, multicohort, dose-escalation trial. Lancet Oncol. 18(5):587-598.

Kaufman HL, Russell J, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbé C, Linette GP, Milella M, Brownell I, Lewis KD, Lorch JH, Chin K, Mahnke L, von Heydebreck A, Cuillerot JM, Nghiem P. (2016). Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 17(10):1374-1385.

Boyerinas B, Jochems C, Fantini M, Heery CR, Gulley JL, Tsang KY, Schlom J. (2015). Antibody-Dependent Cellular Cytotoxicity Activity of a Novel Anti-PD-L1 Antibody Avelumab (MSB0010718C) on Human Tumor Cells. Cancer Immunol Res. 3(10):1148-57.

View All Health Topics

This page was last updated on Tuesday, June 13, 2023