From Hope to Reality: Durable Overall Survival With Immune Checkpoint Inhibitors for Advanced Lung Cancer
Mené sur 550 patients atteints d'un cancer du poumon non à petites cellules de stade avancé, cet essai de phase IB évalue l'efficacité, du point de vue du taux de réponse objective, de la survie globale à 5 ans et de la durée de la réponse, et la toxicité du pembrolizumab en monothérapie (durée médiane de suivi : 60,6 mois)
After several decades of frustratingly small advances, a revolution in the therapeutic landscape of advanced non–small-cell lung cancer (NSCLC) has occurred in the span of only four short years. During this time, several immune checkpoint inhibitors (ICIs)—pembrolizumab, nivolumab, atezolizumab, and durvalumab—have secured approvals from the United States Food and Drug Administration (FDA) for the management of locally advanced and metastatic NSCLC.1-5 ICI alone or in combination with chemotherapy is now the standard first-line therapy for advanced NSCLC without other actionable genomic alterations.
First published in 2015, KEYNOTE-001 was a landmark study exploring the use of the programmed cell death protein 1 (PD-1) antagonist pembrolizumab in treatment-naïve and previously treated advanced NSCLC. In this trial, single-agent pembrolizumab resulted in radiographic responses and established the programmed death ligand 1 (PD-L1) tumor proportion score (TPS) using the anti–PD-L1 pharmDX 22C3 antibody as a useful biomarker for patient selection. Patients with tumor PD-L1 TPS ≥ 50% experienced the highest objective response rate (ORR) and progression-free survival (PFS) at 45.2% and 6.3 months, respectively.1 In 2015, pembrolizumab was granted accelerated approval by the FDA for use in patients with previously treated advanced NSCLC and tumor PD-L1 TPS ≥ 50%.
Journal of Clinical Oncology , éditorial, 2018