6/28/23, 11:52 PM KEYNOTE-024 Pathway Feedback Search Clinical Topics Home Studies KEYNOTE 024 KEYNOTE 024 Disease Non-small cell lung cancer Trial question What is the effect of pembrolizumab in patients who had previously untreated PD-L1 positive advanced non-small cell lung cancer? Study design Multi-center Open label RCT Population Characteristics of study participants 39.0% female N = 305 61.0% male 305 patients (118 female, 187 male) Inclusion criteria: patients with previously untreated advanced non-small cell lung cancer with PD-L expression on at least 50% of tumor cells and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the ALK gene Key exclusion criteria: receiving systemic corticosteroids (excluding daily corticosteroid- replacement therapy for conditions such as adrenal or pituitary insufficiency) or other immunosuppressive treatment or if they had untreated brain metastases, active autoimmune disease for which they had received systemic treatment during the previous 2 years, active ILD, or a history of pneumonitis for which they had received corticosteroids Interventions N=154 pembrolizumab (administered IV at a dose of 200 mg every 3 weeks for 35 cycles) N=151 chemotherapy (investigator's choice of one of the following five platinum-based chemotherapy regimens for 4 to 6 cycles: carboplatin plus pemetrexed, cisplatin plus https://web.pathway.md/studies/recBdUYAhGcbKmWQg 1/2 6/28/23, 11:52 PM KEYNOTE-024 Pathway pemetrexed, carboplatin plus gemcitabine, cisplatin plus gemcitabine, or carboplatin plus paclitaxel) Primary outcome Median progression-free survival 10.3 months 10.3 7.7 months 6 5.2 months 2.6 months Significant decrease 0.0 months Pembrolizumab Chemotherapy Significant decrease in median progression-free survival (10.3 months vs. 6 months; HR 0.5, 95% CI 0.37 to 0.68) Secondary outcomes Significant increase in overall survival at 6 months (80.2% vs. 72.4%; HR 1.66, 95% CI 1.12 to 2.43) Significant increase in objective response (44.8% vs. 27.8%; AD 16.6%, 95% CI 6 to 27) Safety outcomes No significant differences in serious treatment-related adverse events, discontinuation of treatment due to treatment-related adverse events. Significant differences in treatment-related adverse events (73.4% vs. 90.0%), and grade 3-5 treatment-related adverse events (26.6% vs. 53.3%). Conclusion In patients with previously untreated advanced non-small cell lung cancer with PD-L expression on at least 50% of tumor cells and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the ALK gene, pembrolizumab was superior to chemotherapy with respect to median progression-free survival. Reference Reck M, Rodriguez-Abreu D, Robinson AG et al. Pembrolizumab versus Chemotherapy for PD- L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. Open reference URL https://web.pathway.md/studies/recBdUYAhGcbKmWQg 2/2