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Pembrolizumab improves overall survival versus chemotherapy in Chinese patients with advanced NSCLC and PD-L1 expression.

Pembrolizumab improves overall survival versus chemotherapy in Chinese patients with advanced NSCLC …
Photo by Pharmacy Images / Unsplash
Key Takeaway
Consider pembrolizumab monotherapy for advanced NSCLC in Chinese patients with PD-L1 TPS >=1%.

This randomized controlled trial investigated the efficacy and safety of pembrolizumab monotherapy versus chemotherapy in Chinese participants with previously untreated locally advanced or metastatic non-small-cell lung cancer. The study population included patients with PD-L1 tumor proportion score of at least one percent who lacked EGFR or ALK alterations. Participants received pembrolizumab every three weeks for up to 35 cycles or chemotherapy with optional maintenance therapy depending on histology.

The primary analysis focused on overall survival within specific PD-L1 expression subgroups. The trial reported that pembrolizumab improved overall survival compared to chemotherapy in patients with PD-L1 expression of at least 50 percent, at least 20 percent, and at least one percent. These findings suggest a consistent survival benefit across a broad range of PD-L1 positivity levels within this specific Asian cohort.

Regarding safety, the authors observed that severe treatment-related adverse events occurred less frequently in the pembrolizumab group than in the chemotherapy group. Discontinuations due to adverse events were not reported, and the overall tolerability was described as manageable. The study limitations are not explicitly detailed in the provided abstract, though the authors caution that results may not generalize beyond the Chinese population studied.

The practice relevance is that these findings further support the use of pembrolizumab monotherapy as a standard of care for eligible patients with advanced non-small-cell lung cancer. Clinicians should consider this regimen for patients fitting the inclusion criteria, particularly those with higher PD-L1 expression, while monitoring for manageable immune-related toxicities.

Study Details

Study typeRct
Sample sizen = 262
EvidenceLevel 2
PublishedMay 2026
View Original Abstract ↓
In the phase 3 KEYNOTE-042 China study of participants enrolled in China in the global KEYNOTE-042 (NCT02220894) and China extension (NCT03850444) studies, pembrolizumab improved overall survival (OS) versus chemotherapy in locally advanced or metastatic non-small-cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50% (hazard ratio [HR], 0.63; 95% CI, 0.43-0.94), ≥20% (0.66; 0.47-0.92), and ≥1% (0.67; 0.50-0.89). We present outcomes from this study after 5 years of follow-up. Chinese participants with previously untreated locally advanced or metastatic NSCLC with PD-L1 TPS ≥1% without EGFR or ALK alterations were eligible. Participants were randomized 1:1 to pembrolizumab 200 mg every 3 weeks for up to 35 cycles or carboplatin plus paclitaxel or pemetrexed with optional pemetrexed maintenance (nonsquamous only). Primary endpoints were OS in the PD-L1 TPS ≥50%, ≥20%, and ≥1% subgroups. Median follow-up was 63.7 (range, 56.3-72.6) months among 262 participants (pembrolizumab, n = 128; chemotherapy, n = 134) included in this study. Pembrolizumab prolonged OS versus chemotherapy in participants with PD-L1 TPS ≥50% (HR, 0.65; 95% CI, 0.45-0.93), ≥20% (0.67; 0.49-0.91), and ≥1% (0.66; 0.51-0.87). Grade 3 to 5 treatment-related AEs occurred in 19.5% and 68.8% of participants in the pembrolizumab and chemotherapy groups, respectively. In conclusion, after 5 years of follow-up, pembrolizumab continued to demonstrate improved OS versus chemotherapy with manageable safety in Chinese participants with previously untreated locally advanced or metastatic NSCLC that expressed PD-L1. These data further support pembrolizumab monotherapy as a standard of care for these patients.
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