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Pembrolizumab improves overall survival versus chemotherapy in Chinese patients with advanced NSCLC and PD-L1 expressionFive-year follow-up shows pembrolizumab extends life for Chinese lung cancer patients with high PD-L1

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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.

Lung cancer remains one of the deadliest diseases in the world. For many patients, the choice between a new drug and standard chemotherapy feels like a gamble. This study offers hope for a specific group of people in China who face this difficult choice. The research focuses on non-small-cell lung cancer, a common and serious form of the disease. It specifically looks at patients who have not been treated before and have a certain level of a protein called PD-L1 on their cancer cells. This protein helps the cancer hide from the body's immune system. The study followed these patients for five years to see who lived longer.

The researchers in China divided 262 patients into two groups. One group received pembrolizumab. This is a type of immunotherapy that helps the body fight cancer. The other group received chemotherapy, which uses drugs to kill fast-growing cells. The chemotherapy group could get a mix of carboplatin and paclitaxel or pemetrexed. Some patients in this group also got pemetrexed later on. The team watched the patients closely for up to 63.7 months, which is about five years. This long wait is important because it shows what happens in real life, not just in the short term after treatment starts.

The main goal was to see who lived longer. The results were clear for patients with high levels of the PD-L1 protein. Those with the highest levels saw a big benefit from the immunotherapy. The risk of dying was 35 percent lower for them compared to those on chemotherapy. Patients with moderate levels also saw a benefit, with a 33 percent lower risk of death. Even patients with lower levels of the protein saw a 34 percent lower risk of dying. In plain terms, the drug helped more people live longer across different groups of patients.

Safety is always a major concern for patients and families. The study found that serious side effects happened in about 20 percent of people taking pembrolizumab. In the chemotherapy group, serious side effects were much more common, happening in nearly 69 percent of patients. The side effects from the drug were considered manageable. This means doctors could handle them without stopping treatment often. No one had to quit the study because of the drug itself. This suggests the treatment is safe enough for patients to use with confidence.

It is important to remember that this study only included people from China. It also only looked at patients who had not received cancer treatment before. This means the results might not apply to everyone everywhere. The study did not find any new safety problems that were unexpected. However, doctors should always talk to patients about their specific situation. This research supports using pembrolizumab as a standard option for these patients. It gives a clear picture of what to expect over several years. Patients can now make better decisions with this new information.

What this means for you:
Five-year data shows pembrolizumab improves survival for Chinese lung cancer patients with high PD-L1.

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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