首页|PD-L1 expression guidance on sintilimab versus pembrolizumab with or without platinum-doublet chemotherapy in untreated patients with advanced non-small cell lung cancer(CTONG1901):A phase 2,randomized,controlled trial
PD-L1 expression guidance on sintilimab versus pembrolizumab with or without platinum-doublet chemotherapy in untreated patients with advanced non-small cell lung cancer(CTONG1901):A phase 2,randomized,controlled trial
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No direct comparison has been performed between different programmed cell death-1(PD-1)inhibitors for first-line treatment in patients with advanced non-small cell lung cancer(NSCLC).The feasibility of using PD-L1-expression-guided immunotherapy remains unknown.In this open-label,phase 2 study(NCT04252365),patients with advanced NSCLC without EGFR or ALK alterations were randomized(1∶1)to receive sintilimab or pembrolizumab monotherapy(PD-L1 expression ≥ 50％),or sintilimab or pembrolizumab plus platinum-based chemotherapy(PD-L1 expression＜50％).The sample size was cal-culated by optimal two-stage design.The primary endpoint was the objective response rate(ORR).The study included 71 patients(sintilimab arms,n=35;pembrolizumab arms,n=36)and met its primary endpoint,with a confirmed ORR of 51.4％(18/35)in the sintilimab arms.The confirmed ORR(95％confi-dence interval)was 46.2％(19.2％,74.9％)and 42.9％(17.7％,71.1％)for patients treated with sintilimab and pembrolizumab monotherapy;and 54.5％(32.2％,75.6％)and 45.4％(24.4％,67.8％)for those treated with sintilimab-and pembrolizumab-based combination therapies.The median progression-free survival was 6.9 versus 8.1 months for all sintilimab-treated versus all pembrolizumab-treated patients,respectively,in which it was 7.6 versus 11.0 months in monotherapy and 7.4 versus 7.1 months in combination ther-apies.The median overall survival was 14.9 versus 21.3 months for all sintilimab-treated versus all pembrolizumab-treated patients,respectively,in which it was 14.9 versus 22.6 months in monotherapy and 14.7 versus 17.3 months in combination therapies.Treatment-related adverse events were consistent with safety outcomes of monotherapy and combination therapy in previous phase Ⅲ studies.However,the incidence of rash was higher with sintilimab than pembrolizumab monotherapy.This is the first prospective phase 2 study to directly compare two anti-PD-1 antibodies as first-line treatment in advanced NSCLC.Sintilimab was efficacious and well-tolerated irrespective of PD-L1 expression level in patients with advanced NSCLC and had similar efficacy and safety to pembrolizumab.
Department of Hematology,The First Affiliated Hospital,Jinan University,Guangzhou 510632,China
Guangdong Lung Cancer Institute,Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences),Southern Medical University,Guangzhou 510080,China
Chinese Thoracic Oncology Group(CTONG),Guangzhou 510055,China
Institute of Hematology,School of Medicine,Key Laboratory for Regenerative Medicine of Ministry of Education,Jinan University,Guangzhou 510632,China
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Guangdong Provincial Key Lab of Translational Medicine in Lung CancerGuangdong Provincial People's Hospital Scientific Research Funds for Leading Medical Talents in Guangdong ProvinceNational Natural Science Foundation of ChinaNational Natural Science Foundation of ChinaChina Postdoctoral Science FoundationHigh-Level Hospital Construction Project
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