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In post hoc analyses, we characterized antidrug antibody (ADA) development with avelumab monotherapy in patients with metastatic Merkel cell carcinoma (mMCC) from the JAVELIN Merkel 200 trial (first\u2010line [1L; <jats:italic>N<\/jats:italic>\u2009=\u2009116] and second\u2010line or later [\u22652L; <jats:italic>N<\/jats:italic>\u2009=\u200988] cohorts) or with advanced urothelial carcinoma (aUC) from the JAVELIN Bladder 100 (1L maintenance [<jats:italic>N<\/jats:italic>\u2009=\u2009350]) and JAVELIN Solid Tumor (\u22652L [<jats:italic>N<\/jats:italic>\u2009=\u2009249]) trials. Treatment\u2010emergent ADAs developed in a numerically higher proportion of patients with aUC (1L maintenance, 19.1%; \u22652L, 18.1%) versus mMCC (1L, 8.2%; \u22652L, 8.9%); incidences within tumor types were similar by line of therapy. In PK analyses, numerically lower avelumab trough concentration and higher baseline clearance were observed in treatment\u2010emergent ADA+ versus ADA\u2212 subgroups; however, differences were not clinically relevant. Numerical differences in overall survival, progression\u2010free survival, or objective response rate by ADA status were observed; however, no clinically meaningful trends were identified. Proportions of patients with treatment\u2010emergent adverse events (TEAEs; any grade or grade 3\/4), serious TEAEs, TEAEs leading to treatment discontinuation, or infusion\u2010related reactions were similar, with overlapping 80% confidence intervals between ADA subgroups. Efficacy and safety observations were similar in subgroups defined by early development of ADA+ status during treatment. In conclusion, no meaningful differences in PKs, efficacy, and safety were observed between subgroups of avelumab\u2010treated patients with different ADA status. Overall, these data suggest that ADAs are not relevant for treatment decisions with avelumab.<\/jats:p>","DOI":"10.1111\/cts.13730","type":"journal-article","created":{"date-parts":[[2024,2,27]],"date-time":"2024-02-27T11:01:25Z","timestamp":1709031685000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Immunogenicity of avelumab in patients with metastatic Merkel cell carcinoma or advanced urothelial carcinoma"],"prefix":"10.1111","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5779-5743","authenticated-orcid":false,"given":"Ping","family":"Hu","sequence":"first","affiliation":[{"name":"EMD Serono  Billerica Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5160-2779","authenticated-orcid":false,"given":"Haiqing Isaac","family":"Dai","sequence":"additional","affiliation":[{"name":"EMD Serono  Billerica Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-9000-627X","authenticated-orcid":false,"given":"James","family":"Bourdage","sequence":"additional","affiliation":[{"name":"the healthcare business of Merck KGaA  Darmstadt Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-0720-7880","authenticated-orcid":false,"given":"Dongli","family":"Zhou","sequence":"additional","affiliation":[{"name":"the healthcare business of Merck KGaA  Darmstadt Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-0412-2832","authenticated-orcid":false,"given":"Ky","family":"Trang","sequence":"additional","affiliation":[{"name":"the healthcare business of Merck KGaA  Darmstadt Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-3349-2317","authenticated-orcid":false,"given":"Karey","family":"Kowalski","sequence":"additional","affiliation":[{"name":"Pfizer  La Jolla California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-4923-6723","authenticated-orcid":false,"given":"Carlo","family":"Bello","sequence":"additional","affiliation":[{"name":"Pfizer  San Diego California United\u00a0States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6547-2186","authenticated-orcid":false,"given":"Jennifer","family":"Hibma","sequence":"additional","affiliation":[{"name":"Pfizer  San Diego California United\u00a0States"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0472-7173","authenticated-orcid":false,"given":"Akash","family":"Khandelwal","sequence":"additional","affiliation":[{"name":"the healthcare business of Merck KGaA  Darmstadt Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4811-7748","authenticated-orcid":false,"given":"Kyra","family":"Cowan","sequence":"additional","affiliation":[{"name":"the healthcare business of Merck KGaA  Darmstadt Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3825-7074","authenticated-orcid":false,"given":"Jennifer","family":"Dong","sequence":"additional","affiliation":[{"name":"EMD Serono  Billerica Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4039-9813","authenticated-orcid":false,"given":"Karthik","family":"Venkatakrishnan","sequence":"additional","affiliation":[{"name":"EMD Serono  Billerica Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-3149-8486","authenticated-orcid":false,"given":"Wei","family":"Gao","sequence":"additional","affiliation":[{"name":"EMD Serono  Billerica Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,2,27]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"NCCN Clinical Practice Guidelines in Oncology: Merkel cell carcinoma. 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