{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T15:11:31Z","timestamp":1791558691851,"version":"4.3.4"},"reference-count":71,"publisher":"American Association for the Advancement of Science (AAAS)","issue":"8","license":[{"start":{"date-parts":[[2025,5,29]],"date-time":"2025-05-29T00:00:00Z","timestamp":1748476800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Shanghai Henlius Biotech Inc."},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82473000"],"award-info":[{"award-number":["82473000"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Commun"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p xml:lang=\"en\">The ASTRUM\u2010005 study previously demonstrated a significant overall survival (OS) benefit with serplulimab (a programmed death 1 inhibitor) plus chemotherapy versus chemotherapy alone in previously untreated extensive\u2010stage small\u2010cell lung cancer (ES\u2010SCLC). Here, we report updated efficacy and safety results after an extended median follow\u2010up of 19.8 months, along with the first report on findings from exploratory biomarker analyses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      A total of 585 patients were randomized in a 2:1 ratio to receive 4.5 mg\/kg serplulimab (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 389) or placebo (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 196) intravenously every 3 weeks, together with carboplatin and etoposide. The primary endpoint was OS. In addition, genomic profiling was performed to identify mutated genes, and quantitative serum proteome profiling was conducted to identify differentially expressed proteins (DEPs) between responders and non\u2010responders of serplulimab plus chemotherapy. Regression analysis was subsequently used to construct a protein signature based on the DEPs. The associations between efficacy outcomes (objective response rate [ORR], OS, and progression\u2010free survival [PFS]) and gene mutation status or DEP expression were also examined with regression analysis. Furthermore, the prognostic value of hematological parameters was evaluated.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      In the intent\u2010to\u2010treat population, the median OS was 15.8 months in the serplulimab group versus 11.1 months in the placebo group (hazard ratio, 0.62; 95% confidence interval, 0.50\u20100.76;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; 0.001). We identified 181 DEPs between responders and non\u2010responders in the serplulimab group, from which a 15\u2010protein signature was constructed. In the serplulimab group, patients with a higher 15\u2010protein signature score were associated with significantly longer OS and PFS. Also, patients harboring tumor\u2010suppressor retinoblastoma\u20101 (\n                      <jats:italic toggle=\"yes\">RB1<\/jats:italic>\n                      ) mutations or mutations in Notch pathway members showed improved ORR, OS, or PFS compared with their wild\u2010type counterparts. Baseline neutrophil\u2010to\u2010lymphocyte ratio (NLR) and lactate dehydrogenase (LDH) level were independent prognosticators of patients with ES\u2010SCLC.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p xml:lang=\"en\">\n                      First\u2010line serplulimab provided a sustained clinical benefit over placebo in patients with ES\u2010SCLC. A 15\u2010protein signature and mutations in\n                      <jats:italic toggle=\"yes\">RB1<\/jats:italic>\n                      or Notch pathway genes may serve as predictive biomarkers for benefits from serplulimab plus chemotherapy, while baseline NLR and LDH were independent prognosticators for ES\u2010SCLC.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cac2.70032","type":"journal-article","created":{"date-parts":[[2025,5,29]],"date-time":"2025-05-29T12:38:29Z","timestamp":1748522309000},"page":"990-1009","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["First\u2010line serplulimab plus chemotherapy in extensive\u2010stage small\u2010cell lung cancer: Updated results and biomarker analysis from the ASTRUM\u2010005 randomized clinical trial"],"prefix":"10.34133","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9908-597X","authenticated-orcid":false,"given":"Ying","family":"Cheng","sequence":"first","affiliation":[{"name":"Jilin Cancer Hospital","place":["Changchun, P. 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