A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004)

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dc.contributor.authorZhou, Caicun
dc.contributor.authorHu, Yanping
dc.contributor.authorArkania, Ekaterine
dc.contributor.authorKilickap, Saadettin
dc.contributor.authorYing, Kejing
dc.contributor.authorXu, Fei
dc.contributor.authorWu, Lin
dc.date.accessioned2024-05-19T14:50:28Z
dc.date.available2024-05-19T14:50:28Z
dc.date.issued2024
dc.departmentİstinye Üniversitesien_US
dc.description.abstractCombining immunotherapy with chemotherapy can provide improved survival in advanced squamous nonsmall -cell lung cancer (NSCLC) patients without targetable gene alterations. 537 previously untreated patients with stage IIIB/IIIC or IV squamous NSCLC without targetable gene alterations were enrolled and randomized (2:1) to receive serplulimab 4.5 mg/kg or placebo, both in combination with nab-paclitaxel and carboplatin, intravenously in 3 -week cycles. The primary endpoint of progression -free survival (PFS) was met at the first interim analysis. At the second interim analysis, PFS benefit was maintained in serplulimab-chemotherapy group (hazard ratio [HR] 0.53, 95% confidence interval [CI] 0.42-0.67). At the final analysis, serplulimab-chemotherapy significantly improved median OS compared to placebo -chemotherapy (HR 0.73, 95% CI 0.58-0.93; p = 0.010). Grade R3 serplulimab or placebo -related adverse events occurred in 126 (35.2%) and 58 (32.4%) patients, respectively. Our results demonstrate that adding serplulimab to chemotherapy significantly improves survival in advanced squamous NSCLC patients, with manageable safety.en_US
dc.description.sponsorshipShanghai Henlius Biotech, Inc.en_US
dc.description.sponsorshipThis work was funded by Shanghai Henlius Biotech, Inc. We would like to acknowledge the patients who participated in the trial, their families, the principal investigators, clinicians, study coordinators, and nurses. We thank the clinical study team (Clinical Operations: Qiong Wang; Statistics: Yali Liu, Wenting Qiu, Jiancheng Cheng) and Wenjie Zhang from Shanghai Henlius Biotech, Inc., for their support in study execution, study design, data acquisition, statistical analyses, and manuscript revisions. Medical writing support was provided by JingYi Lee and Xinlei Yu of Parexel, and Shiqi Zhong and Chen Hu of Shanghai Henlius Biotech, Inc., and funded by Shanghai Henlius Biotech, Inc.en_US
dc.identifier.doi10.1016/j.ccell.2023.12.004
dc.identifier.issn1535-6108
dc.identifier.issn1878-3686
dc.identifier.issue2en_US
dc.identifier.pmid38181795en_US
dc.identifier.urihttps://doi.org10.1016/j.ccell.2023.12.004
dc.identifier.urihttps://hdl.handle.net/20.500.12713/5720
dc.identifier.volume42en_US
dc.identifier.wosWOS:001183731600001en_US
dc.identifier.wosqualityN/Aen_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.language.isoenen_US
dc.publisherCell Pressen_US
dc.relation.ispartofCancer Cellen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.snmz20240519_kaen_US
dc.subjectNab-Paclitaxelen_US
dc.subjectGemcitabineen_US
dc.subjectCarboplatinen_US
dc.subjectPlaceboen_US
dc.subjectTrialen_US
dc.titleA global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004)en_US
dc.typeArticleen_US

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