{"id":27997,"date":"2025-05-13T04:45:00","date_gmt":"2025-05-12T20:45:00","guid":{"rendered":"https:\/\/csccm.org.cn\/?p=27997"},"modified":"2025-05-13T05:32:20","modified_gmt":"2025-05-12T21:32:20","slug":"lancet%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e8%a1%a3%e6%b2%83%e8%a5%bf%e5%8d%95%e6%8a%97%e4%b8%8e%e6%b4%be%e5%a7%86%e5%8d%95%e6%8a%97%e6%b2%bb%e7%96%97pd-l1%e9%98%b3%e6%80%a7%e9%9d%9e","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=27997","title":{"rendered":"[Lancet\u53d1\u8868\u8bba\u6587]\uff1a\u8863\u6c83\u897f\u5355\u6297\u4e0e\u6d3e\u59c6\u5355\u6297\u6cbb\u7597PD-L1\u9633\u6027\u975e\u5c0f\u7ec6\u80de\u80ba\u764c"},"content":{"rendered":"\n

ARTICLES<\/strong>Volume 405, Issue 10481<\/a>P839-849March 08, 2025Download Full Issue<\/p>\n\n\n\n

Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China<\/h1>\n\n\n\n

Anwen\u00a0Xiong,\u00a0Lei\u00a0Wang,\u00a0Jianhua\u00a0Chen,\u00a0et al<\/h3>\n\n\n\n

Lancet 2025; 405: 839-849<\/h3>\n\n\n\n

Summary<\/h2>\n\n\n\n

Background<\/h3>\n\n\n\n

Ivonescimab is a bispecific antibody against programmed cell death protein 1 and vascular endothelial growth factor, yielding promising clinical outcomes for patients with advanced non-small cell lung cancer in early-phase studies. We compared the efficacy and safety of ivonescimab with pembrolizumab in patients with programmed cell death ligand-1 (PD-L1)-positive advanced non-small cell lung cancer.<\/p>\n\n\n\n

Methods<\/h3>\n\n\n\n

HARMONi-2 is a randomised, double-blind, phase 3 trial across 55 hospitals in China. Eligible patients were aged 18 years or older and had locally advanced or metastatic PD-L1-positive non-small cell lung cancer without sensitising epidermal growth factor receptor mutations or anaplastic lymphoma kinase translocations and an Eastern Cooperative Oncology Group performance-status of 0 or 1. Patients were randomly assigned (1:1) to receive 20 mg\/kg ivonescimab or 200 mg pembrolizumab intravenously every 3 weeks. Randomisation was stratified by histology, clinical stage, and PD-L1 expression. The primary endpoint was progression-free survival (PFS) assessed by a masked independent radiographic review committee per RECIST v1.1 in the intention-to-treat population. This study is registered with ClinicalTrials.gov<\/a>, NCT05499390<\/a>; recruitment is complete, with the trial ongoing and final analysis to be reported later.<\/p>\n\n\n\n

Findings<\/h3>\n\n\n\n

Between Nov 9, 2022, and Aug 26, 2023, 398 (45%) of 879 screened patients were randomly assigned to receive ivonescimab (n=198) or pembrolizumab (n=200). At the preplanned interim analysis, median PFS was significantly longer with ivonescimab than with pembrolizumab (11\u00b71\u00a0vs<\/em>\u00a05\u00b78 months; stratified hazard ratio [HR] 0\u00b751 [95% CI 0\u00b738\u20130\u00b769]; one-sided p<0\u00b70001). The PFS benefit of ivonescimab over pembrolizumab was broadly consistent within prespecified subgroups, including patients with PD-L1 tumour proportion score (TPS) 1\u201349% (HR 0\u00b754 [95% CI 0\u00b737\u20130\u00b778]) and PD-L1 TPS of 50% of higher (HR 0\u00b748 [0\u00b729\u20130\u00b779]). Grade 3 or higher treatment-related adverse events occurred in 58 (29%) patients with ivonescimab and 31 (16%) patients with pembrolizumab. Immune-related adverse events of grade 3 or higher were observed in 14 (7%) of 197 patients on ivonescimab and 16 (8%) of 199 patients on pembrolizumab. Ivonescimab demonstrated a manageable safety profile in patients with both squamous and non-squamous non-small cell lung cancer. In patients with squamous cell carcinoma, grade 3 or higher treatment-related adverse events were comparable between the two groups.<\/p>\n\n\n\n

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Interpretation<\/h3>\n\n\n\n

Ivonescimab significantly improved PFS compared with pembrolizumab in previously untreated patients with advanced PD-L1 positive non-small cell lung cancer. Therefore, ivonescimab might represent another treatment option in the first-line setting for PD-L1-positive advanced non-small cell lung cancer.<\/p>\n\n\n\n

Funding<\/h3>\n\n\n\n

Akeso Biopharma.<\/p>\n","protected":false},"excerpt":{"rendered":"

ARTICLESVolume 405, Issue 10481P839-849March 08, 2 […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/27997"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=27997"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/27997\/revisions"}],"predecessor-version":[{"id":27998,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/27997\/revisions\/27998"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=27997"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=27997"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=27997"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}