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

• DOI: 10.1016/j.scib.2023.12.046
• Publication Date: 2023-12-26T16:37:15Z
• Authors: Si-Yang Maggie Liu; Jie Huang; Jia-Yi Deng; Chong-Rui Xu; Hong-Hong Yan; Ming-Yi Yang; Yang-Si Li; E-E Ke; Ming-Ying Zheng; Zhen Wang; Jia-Xin Lin; Bin Gan; Xu-Chao Zhang; Hua-Jun Chen; Bin-Chao Wang; Hai-Yan Tu; Jin-Ji Yang; Wen-Zhao Zhong; Yangqiu Li; Qing Zhou; Yi-Long Wu

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 lung cancer (NSCLC). The feasibility of using PD-L1-expression-guided immunotherapy remains unknown. In this open-label, phase 2 study (NCT04252365), NSCLC without EGFR or ALK alterations were randomized (1:1) to receive sintilimab pembrolizumab monotherapy (PD-L1 expression ≥50%), plus platinum-based chemotherapy <50%). sample size was calculated by optimal two-stage design. primary endpoint the objective response rate (ORR). included 71 (sintilimab arms, n = 35; 36) and met its endpoint, a confirmed ORR 51.4% (18/35) arms. (95% confidence interval) 46.2% (19.2%, 74.9%) 42.9% (17.7%, 71.1%) treated monotherapy; 54.5% (32.2%, 75.6%) 45.4% (24.4%, 67.8%) those sintilimab- pembrolizumab-based combination therapies. median progression-free survival 6.9 versus 8.1 months all sintilimab-treated pembrolizumab-treated patients, respectively, which it 7.6 11.0 7.4 7.1 overall 14.9 21.3 22.6 14.7 17.3 Treatment-related adverse events consistent safety outcomes therapy previous III studies. However, incidence rash higher than monotherapy. This is first prospective directly compare two anti-PD-1 antibodies as NSCLC. Sintilimab efficacious well-tolerated irrespective PD-L1 level had similar efficacy pembrolizumab.