{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T11:21:00Z","timestamp":1769253660524,"version":"3.49.0"},"reference-count":29,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T00:00:00Z","timestamp":1761696000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009857","name":"Regeneron Pharmaceuticals, Inc","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100009857","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>EMPOWER-Lung 1 and EMPOWER-Lung 3 (phase 3 studies) demonstrated survival benefits for cemiplimab with\/without chemotherapy in global (non-Japanese) patients with advanced non-small cell lung cancer (aNSCLC). This single-arm dose-expansion study assessed safety, tolerability, pharmacokinetics, and efficacy of first-line cemiplimab (350\u00a0mg intravenous every 3\u00a0weeks) as monotherapy\/with chemotherapy in Japanese patients with aNSCLC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The primary objectives were safety, tolerability, and pharmacokinetics of cemiplimab as monotherapy\/with chemotherapy. Secondary objectives included immunogenicity, tumor response (objective response rate [ORR], and duration of response [DOR]). Patients whose tumors expressed programmed cell death-ligand 1 (PD-L1) \u226550% on tumor cells received cemiplimab monotherapy (Cohort A; n\u00a0=\u00a060, safety; n\u00a0=\u00a050, efficacy). Patients whose tumors expressed any level of PD-L1 received cemiplimab plus four cycles of chemotherapy (Cohort C; n\u00a0=\u00a050).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Safety results were generally consistent with the known safety profile of cemiplimab. Treatment-emergent adverse events (grade\u00a0\u22653) were experienced by 51.7% (31\/60) in patients receiving cemiplimab monotherapy (Cohort A) and 68.0% (34\/50) in those receiving cemiplimab + chemotherapy (Cohort C). Pharmacokinetic results were similar across both cohorts. In Cohort A patients with centrally confirmed PD-L1\u00a0\u226550%, ORR was 60.0% (30\/50) with an observed DOR of 2.1\u201342.5\u00a0months. In Cohort C, ORR was 42.0% (21\/50) with an observed DOR of 2.3\u201320.7\u00a0months. Immunogenicity was low in both cohorts.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Cemiplimab demonstrated efficacy in Japanese patients as monotherapy for PD-L1\u00a0\u226550% and with chemotherapy irrespective of PD-L1 expression. Overall, cemiplimab demonstrated a favorable benefit\u2013risk profile in Japanese patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jjco\/hyaf160","type":"journal-article","created":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T12:22:39Z","timestamp":1759926159000},"page":"55-65","source":"Crossref","is-referenced-by-count":0,"title":["Cemiplimab in Japanese patients with advanced non-small cell lung cancer"],"prefix":"10.1093","volume":"56","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7829-7524","authenticated-orcid":false,"given":"Yuki","family":"Sato","sequence":"first","affiliation":[{"name":"Department of Respiratory Medicine, Kobe City Medical Center General Hospital , Kobe ,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoko","family":"Tani","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Osaka Metropolitan University Hospital , Osaka 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Thoracic Oncology, Saitama Cancer Center , Saitama ,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshihide","family":"Yokoyama","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Kurashiki Central Hospital , Kurashiki ,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katsuhiko","family":"Naoki","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Kitasato University Hospital , Kanagawa ,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean-Francois","family":"Pouliot","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc. , Tarrytown, NY ,","place":["United States"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manika","family":"Kaul","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc. , Tarrytown, NY ,","place":["United 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