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Frontline, single-agent pembrolizumab (KeytrudaⓇ) improves overall survival (OS) when compared to investigator choice (IC) platinum-based chemotherapy in patients with advanced non–small cell lung cancer (NSCLC) and a tumour proportion score (TPS) PD-L1 expression ≥1%.
This was the conclusion of the pivotal Phase 3 KEYNOTE-042 trial which compared pembrolizumab 1:1 with IC platinum-doublet chemotherapy in 1247 squamous and non-squamous NSCLC patients. IC chemotherapy was either carboplatin plus pemetrexed or carboplatin plus paclitaxel. Patients with aberrations in the ALK or EGFR gene were excluded from the study.
“Improvement in overall survival is the ultimate objective in the treatment of advanced lung cancer. KEYNOTE-042 is the first randomized Phase 3 study of a single-agent immunotherapy using overall survival as the primary endpoint that has demonstrated significant benefit as first-line therapy in NSCLC patients who tested positive for PD-L1 at 1 percent or higher.”
~Prof. Tony SK Mok, Department of Clinical Oncology, the Chinese University of Hong Kong
The primary endpoint OS in the KEYNOTE-042 study was sequentially tested and of statistical significance in subsets of patients with a PD-L1 TPS ≥50%, PD-L1 TPS ≥20%, and in the entire study population with a PD-L1 TPS ≥1%. Safety data of pembrolizumab was reported similar to prior single-agent studies of the PD-1 immunotherapy in advanced NSCLC.
KEYNOTE-024 in PD-L1 ≥50% expression
Previously, the Phase 3 KEYNOTE-024 study showed the drug to more than double the OS in the frontline setting for patients with Stage IIIb and IV NSCLC and a TPS ≥50% when compared to platinum-based chemotherapy (Figure 1). Based on the results of this KEYNOTE-024 trial, the United States Food and Drug Administration (US FDA) approved pembrolizumab for 1st-line treatment of patients with metastatic NSCLC of any histology, negative EGFR and ALK status, and a PD-L1 TPS ≥50% in October 2016.
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Publication of the KEYNOTE-042 results
The independent Data Monitoring Committee (DMC) recommended the KEYNOTE-042 trial to continue for evaluation of the secondary endpoint progression-free survival (PFS). Merck & Co (MSD) announced the results of the KEYNOTE-042 with pembrolizumab in advanced and metastatic NSCLC had been submitted to regulatory agencies around the globe. The results of the study will be presented at an upcoming medical meeting.
This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
© Copyright 2018 MediPaper Medical Communications Ltd. – Pembrolizumab effective in frontline NSCLC with low PD-L1 expression; Results of the KEYNOTE-042 (NCT02220894) show KeytrudaⓇ (pembrolizumab) effective in NSCLC with low PD-L1-expression (TPS≥1%)