Pembrolizumab Plus Chemotherapy for Metastatic Squamous Non‒Small-Cell Lung Cancer: Long-Term Follow-Up of the KEYNOTE-407 China Study

作者：Jie Hu, Ying Cheng, Li Zhang, Donglin Wang, ChengPing Hu, Jianying Zhou, Lin Wu, Lejie Cao, Jiwei Liu, Helong Zhang, Hong Sun, Ziping Wang, Hongjun Gao, Yuping Sun, Xiaohan Hu, Erin Jensen, Kumar Rajagopalan, Luis Paz‐Ares · 发表于：JTO Clinical and Research Reports · 年份：2026 · DOI：10.1016/j.jtocrr.2026.101041 · 研究领域：Cancer Immunotherapy and Biomarkers、Lung Cancer Treatments and Mutations、Lung Cancer Diagnosis and Treatment

Background Pembrolizumab plus chemotherapy prolonged overall survival (OS) and progression-free survival (PFS) versus placebo plus chemotherapy with manageable toxicity among participants with metastatic squamous non‒small-cell lung cancer (mNSCLC) enrolled in China in KEYNOTE-407 global (NCT02775435) and China extension (NCT03875092) studies. We report outcomes after ⁓5 years of follow-up from KEYNOTE-407 China. Methods Eligible participants from China with previously untreated squamous mNSCLC were randomized 1:1 to pembrolizumab 200 mg or placebo plus carboplatin and paclitaxel/nab-paclitaxel every 3 weeks for 4 cycles, followed by pembrolizumab/placebo for ≤35 total cycles. Primary endpoints were OS and PFS per RECIST v1.1 by blinded independent central review. Results Among 125 participants (pembrolizumab plus chemotherapy, n=65; placebo plus chemotherapy, n=60), median follow-up was 56.5 (range, 53.5‒69.3) months at database cutoff (February 10, 2023). Median (95% CI) OS was 29.6 (18.2‒50.4) months for pembrolizumab and 12.7 (9.4‒17.3) for placebo; OS hazard ratio (HR) was 0.43 (95% CI, 0.29‒0.65). Median (95% CI) PFS was 8.3 (6.2‒10.5) months versus 4.2 (4.0‒5.4), and HR was 0.35 (95% CI, 0.24‒0.52). Grade 3‒5 treatment-related adverse events occurred in 81.5% and 81.7% of participants, respectively. Among 20 participants who completed 35 cycles of pembrolizumab, objective response rate was 90.0%; 3-year OS rate after completion of 35 cycles (∼5 years after randomizatio...