# Five‐year outcomes of pembrolizumab versus chemotherapy in Chinese patients with non‐small‐cell lung cancer and programmed cell death ligand 1 tumor proportion score ≥1%: KEYNOTE‐042 China study

## TL;DR

A 5-year study in China found that pembrolizumab, an immunotherapy drug, improved survival and had fewer side effects than chemotherapy for non-small-cell lung cancer patients with PD-L1 expression.

## Contribution

This study provides long-term evidence supporting pembrolizumab as a standard treatment for Chinese patients with PD-L1-positive non-small-cell lung cancer.

## Key findings

- Pembrolizumab improved overall survival versus chemotherapy in PD-L1 TPS ≥1% NSCLC patients.
- Over half of pembrolizumab-treated patients were alive 3 years after treatment initiation.
- Pembrolizumab had fewer treatment-related side effects compared to chemotherapy.

## 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.

What's new?

Global research has found that for people newly diagnosed with advanced non‐small cell lung cancer (NSCLC), the anti‐PD‐1 monoclonal antibody pembrolizumab on its own often leads to better results than traditional chemotherapy. The present report details long‐term findings of pembrolizumab therapy specifically among Chinese patients. Data show that more than half of patients with previously untreated NSCLC who finished the full course of pembrolizumab were still alive 3 years later—roughly 5 years after they first joined the study. Though immune‐mediated adverse events were more common, patients taking pembrolizumab also experienced fewer treatment‐related side effects than those receiving chemotherapy.