Randomized clinical trial of pembrolizumab vs chemotherapy for previously untreated Chinese patients with PD‐L1‐positive locally advanced or metastatic non–small‐cell lung cancer: KEYNOTE‐042 China Study

Autor: Yi‐Long Wu, Li Zhang, Yun Fan, JianYing Zhou, Qing Zhou, Wei Li, ChengPing Hu, GongYan Chen, Xin Zhang, CaiCun Zhou, Thao Dang, Sara Sadowski, Debra A. Kush, Yu Zhou, Ben Li, Tony Mok
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: International Journal of Cancer
ISSN: 1097-0215
0020-7136
Popis: In the global KEYNOTE‐042 study (Clinicaltrials.gov, NCT02220894), pembrolizumab significantly improved overall survival (OS) vs chemotherapy in patients with previously untreated programmed death ligand 1 (PD‐L1)‐positive locally advanced/metastatic non–small‐cell lung cancer (NSCLC) without EGFR/ALK alterations. We present results from patients in KEYNOTE‐042 enrolled from China in the global or extension study (NCT03850444; protocol identical to global study). Patients were randomized 1:1 (stratified by ECOG performance status 0 vs 1, squamous vs nonsquamous histology and PD‐L1 tumor proportion score [TPS] ≥50% vs 1%‐49%) to 35 cycles of pembrolizumab 200 mg every 3 weeks (Q3W) or investigator's choice of 4 to 6 cycles of carboplatin plus paclitaxel or pemetrexed Q3W with optional pemetrexed maintenance for nonsquamous tumors. Primary endpoints were OS in patients with PD‐L1 TPS ≥50%, ≥20% or ≥1%. Two hundred sixty‐two patients (pembrolizumab, n = 128; chemotherapy, n = 134) were enrolled from China. At data cutoff (February 21, 2020; median follow‐up, 33.0 [range, 25.6‐41.9] months), pembrolizumab was shown to improve OS vs chemotherapy in patients with PD‐L1 TPS ≥50% (hazard ratio [95% CI], 0.63 [0.43‐0.94]), TPS ≥20% (0.66 [0.47‐0.92]) and TPS ≥1% (0.67 [0.50‐0.89]). Grade 3 to 5 treatment‐related adverse events occurred less frequently with pembrolizumab vs chemotherapy (19.5% vs 68.8%). In 22 patients who completed 35 cycles of pembrolizumab, objective response rate was 77.3% and median duration of response was 27.6 months. Consistent with the global KEYNOTE‐042 study, pembrolizumab improved OS vs chemotherapy in this study of Chinese patients with locally advanced/metastatic NSCLC and PD‐L1 TPS ≥1%, supporting first‐line pembrolizumab monotherapy for PD‐L1‐positive advanced/metastatic NSCLC in China.
What's new? The global KEYNOTE‐042 clinical study helped establish single‐agent pembrolizumab, an anti‐PD‐1 monoclonal antibody, as a standard first‐line treatment option in patients with previously untreated PD‐L1‐positive locally advanced/metastatic non–small‐cell lung cancer (NSCLC) without EGFR/ALK aberrations. Because disease characteristics and responses to anticancer therapy may differ between Asian and other populations, there is a need to evaluate these treatments specifically in Asian patients. Here, the authors show that pembrolizumab also improved overall survival and was better tolerated than chemotherapy among Chinese patients with PD‐L1 TPS ≥1% in the KEYNOTE‐042 study. These data support first‐line pembrolizumab monotherapy for PD‐L1‐positive advanced/metastatic NSCLC in China.
Databáze: OpenAIRE
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