{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T19:15:26Z","timestamp":1781118926221,"version":"3.54.1"},"reference-count":33,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"9","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO Precis Oncol"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:sec>\n            <jats:title>PURPOSE<\/jats:title>\n            <jats:p>Multiple immunohistochemistry (IHC) assays targeting PD-L1 have been developed independently, and a lack of harmonization creates undue complexity for clinicians who use PD-L1 tests to guide treatment decisions. This novel bridging study demonstrates the clinical interchangeability of two PD-L1 IHC assays in first-line treatment of non\u2013small cell lung cancer (NSCLC) with PD-L1 \u226550%.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>METHODS<\/jats:title>\n            <jats:p>\n              In the phase III EMPOWER-Lung 1 study (ClinicalTrials.gov identifier:\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT03088540\">NCT03088540<\/jats:ext-link>\n              ), 710 patients were randomly assigned 1:1 to first-line cemiplimab or platinum-doublet chemotherapy for advanced NSCLC with PD-L1 \u226550%, selected by PD-L1 IHC 22C3 pharmDx (Agilent Technologies, Santa Clara, CA).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS<\/jats:title>\n            <jats:p>A total of 871 patient samples were retrospectively tested using the VENTANA PD-L1 (SP263) assay (Roche Diagnostics, Indianapolis, IN), including 481 enrolled patients and 390 patients who did not pass screening (22C3 PD-L1 &lt;50%). Concordance of 22C3 and SP263 was evaluated in 768 patient samples, with an overall percent agreement (concordance) of 88% between the two assays. Overall survival (OS) and progression-free survival (PFS) were estimated in the PD-L1 \u226550% SP263+ population (including the 22C3+\/SP263+ and 22C3\u2013\/SP263+ subpopulations). In the primary analysis, the clinical efficacy of cemiplimab versus chemotherapy in the 22C3+\/SP263+ population (n = 324; OS hazard ratio [HR], 0.52 [95% CI, 0.34 to 0.80]; PFS HR, 0.43 [95% CI, 0.32 to 0.59]) was similar to that in the 22C3+ population (n = 563). A sensitivity analysis of the overall SP263+ population showed consistent results with the primary analysis.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION<\/jats:title>\n            <jats:p>Similar efficacy (OS and PFS) was observed with the 22C3+ and SP263+ populations, demonstrating the interchangeability of these PD-L1 IHC assays for selecting patients with PD-L1 \u226550% for first-line cemiplimab monotherapy for advanced NSCLC.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1200\/po-25-00177","type":"journal-article","created":{"date-parts":[[2025,9,24]],"date-time":"2025-09-24T19:59:12Z","timestamp":1758743952000},"update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":1,"title":["Clinical Interchangeability of PD-L1 Immunohistochemistry Assays in First-Line Non\u2013Small Cell Lung Cancer Management With Cemiplimab"],"prefix":"10.1200","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-2644-6078","authenticated-orcid":true,"given":"Javier","family":"Perez","sequence":"first","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc, Tarrytown, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith M.","family":"Kerr","sequence":"additional","affiliation":[{"name":"Aberdeen University Medical School, University of Aberdeen, Aberdeen, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Baker","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc, Tarrytown, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fang","family":"Fang","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc, Tarrytown, NY"},{"name":"Roche Molecular Systems, Inc, Pleasanton, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Li","sequence":"additional","affiliation":[{"name":"Roche Molecular Systems, Inc, Pleasanton, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jannine","family":"McDonald","sequence":"additional","affiliation":[{"name":"Roche Tissue Diagnostics, Tucson, AZ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siyu","family":"Li","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc, Tarrytown, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bo","family":"Gao","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc, Tarrytown, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Francois","family":"Pouliot","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc, Tarrytown, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Seebach","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc, Tarrytown, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Israel","family":"Lowy","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc, Tarrytown, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Gullo","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc, Tarrytown, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary","family":"Herman","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc, Tarrytown, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1236-5245","authenticated-orcid":true,"given":"Jennifer","family":"Hamilton","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc, 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