{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T01:06:17Z","timestamp":1780967177228,"version":"3.54.1"},"reference-count":44,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T00:00:00Z","timestamp":1776988800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T00:00:00Z","timestamp":1776988800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2026,5,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The dose escalation phase of a first\u2010in\u2010human (FIH) study demonstrated acceptable safety and preliminary antitumor activity of fianlimab (anti\u2010lymphocyte activation gene\u20103 [LAG\u20103]) as monotherapy and in combination with cemiplimab (anti\u2010programmed cell death\u20101 [PD\u20101]). Here, the authors present safety and clinical activity data from the dose\u2010expansion portion of the FIH study in patients with advanced non\u2013small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC), head and neck squamous cell carcinoma (HNSCC), and cutaneous squamous cell carcinoma (CSCC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Anti\u2013PD\u20101\/PD\u2010L1 naive (N) or experienced (E) patients with advanced NSCLC, ccRCC, HNSCC, and CSCC were enrolled in this phase 1 study (NCT03005782). Patients received fianlimab 1600 mg plus cemiplimab 350 mg intravenously every 3 weeks for up to 24 months. The primary end point was the objective response rate (ORR) per RECIST 1.1.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Investigator\u2010assessed ORR was 27% in NSCLC\u2010N (four partial responses [PRs]), 7% in NSCLC\u2010E (one PR), 20% in ccRCC\u2010N (three PRs), 7% in ccRCC\u2010E (one PR), 33% in HNSCC\u2010N (five PRs), 7% in HNSCC\u2010E (one PR), and 20% CSCC\u2010E (two complete responses; one PR). The most common treatment\u2010related treatment\u2010emergent adverse events among patients across all cohorts were fatigue (15%), rash (12%), pruritus (10%), infusion\u2010related reaction (10%), and adrenal insufficiency (10%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Fianlimab plus cemiplimab demonstrated modest clinical efficacy with an acceptable safety profile in patients with advanced malignancies across several tumor types mostly in treatment\u2010naive patients. Further investigation is warranted.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cncr.70396","type":"journal-article","created":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T11:56:53Z","timestamp":1777031813000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Fianlimab, a human lymphocyte activation gene\u20103 monoclonal antibody, in combination with cemiplimab: Tumor\u2010specific expansion cohorts in advanced malignancies"],"prefix":"10.1002","volume":"132","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6145-4426","authenticated-orcid":false,"given":"Tae Min","family":"Kim","sequence":"first","affiliation":[{"name":"Department of Internal Medicine Seoul National University Hospital Seoul National University College of Medicine  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen K.","family":"Williamson","sequence":"additional","affiliation":[{"name":"Department of Oncology The University of Kansas Medical Center  Kansas City Kansas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyriakos P.","family":"Papadopoulos","sequence":"additional","affiliation":[{"name":"Clinical Research START San Antonio The START Center for Cancer Research  San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omid","family":"Hamid","sequence":"additional","affiliation":[{"name":"Melanoma Center The Angeles Clinic and Research Institute  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grace K.","family":"Dy","sequence":"additional","affiliation":[{"name":"Department of Medicine Roswell Park Comprehensive Cancer Center  Buffalo New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ray","family":"McDermott","sequence":"additional","affiliation":[{"name":"Tallaght University Hospital  Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ariel","family":"Birnbaum","sequence":"additional","affiliation":[{"name":"Department of Medicine Rhode Island Hospital  Providence Rhode Island USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John M.","family":"Kaczmar","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology MUSC Hollings Cancer Center  North Charleston South Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nehal","family":"Lakhani","sequence":"additional","affiliation":[{"name":"START Center for Cancer Research  Grand Rapids Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danny","family":"Rischin","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Peter MacCallum Cancer Centre and The University of Melbourne  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debashis","family":"Sarker","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Guy\u2019s and St. Thomas\u2019 NHS Foundation Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Afshin","family":"Dowlati","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology University Hospitals Cleveland Medical Center  Cleveland Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin\u2010Hua","family":"Zhu","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology and Hematology R.J. Zuckerberg Cancer Center Northwell Health Cancer Institute  Lake Success New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jyoti","family":"Malhotra","sequence":"additional","affiliation":[{"name":"Rutgers University  New Brunswick New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Francois","family":"Pouliot","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jayakumar","family":"Mani","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Brennan","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fang","family":"Fang","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuquan","family":"Chen","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Salvati","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Israel","family":"Lowy","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmed","family":"Khaled","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karl D.","family":"Lewis","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Glenn","family":"Kroog","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew G.","family":"Fury","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc  Tarrytown New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5562-270X","authenticated-orcid":false,"given":"Byoung Chul","family":"Cho","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology Yonsei Cancer Center Yonsei University College of Medicine  Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,4,24]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.3390\/curroncol29050247"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/jitc\u20102020\u2010001014"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/1521\u20104141(200208)32:8<2255::AID\u2010IMMU2255>3.0.CO;2\u2010A"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/bf00241263"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.94.11.5744"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/imr.12519"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/eji.201344413"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev\u2010immunol\u2010041015\u2010055318"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.smim.2019.101305"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/ni.2035"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2022.40.36_suppl.360385"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2109970"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1158\/1535\u20107163.Mct\u201018\u20101376"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1158\/1535\u20107163.Mct\u201016\u20100665"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1324022111"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078\u20100432.Ccr\u201023\u20103883"},{"key":"e_1_2_9_18_1","doi-asserted-by":"crossref","unstructured":"McKeanM WeiseAM PapadopoulosKP et\u00a0al.1097P Long\u2010term follow\u2010up of advanced melanoma (unresectable\/metastatic \u2010 aMel) patients (pts) treated with fianlimab (FIAN) + cemiplimab (CEMI): Results from blinded independent central review (BICR) efficacy assessment. 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