Keynote 024 trial10/13/2023 ![]() Patients receiving pembrolizumab also had more favorable changes in scores on individual QLQ-C30 scales for functioning and symptoms and in QLQ-LC13 scores for specific symptoms.īased on these data, pembrolizumab has been proposed as a new standard first-line treatment for advanced NSCLC with a PD-L1 expression TPS of greater than or equal to 50%. Study results showed that at week 15, patients in the pembrolizumab group had experienced an increase in QLQ-C30 mean score of 6.9 points, whereas those in the chemotherapy group had experienced a decrease in QLQ-C30 mean score of 0.9 points (P=0.002).įurthermore, patients enrolled in the pembrolizumab group had a significant longer time to deterioration as revealed by the QLQ-LC13 with regard to cough, chest pain and dyspnea, which was defined as a reduction in the score for at least 1 of these symptoms by at least 10 points and confirmed by a second reduction of that magnitude (HR =0.66 P=0.029). In that study, pembrolizumab yields better health-related quality of life than platinum-based chemotherapy. also reported the prespecified analysis on patient-reported outcomes (PROs) ( 7). 27.8%, respectively) and a longer duration of response with also a better toxicity profile than chemotherapy.īrahmer et al. Furthermore, pembrolizumab showed higher response rates (44.8% vs. Despite 44% of patients made a crossover from chemotherapy to immunotherapy, pembrolizumab showed a significant improvement in OS. In fact, the difference of PFS and OS in favor of pembrolizumab was statistically and clinically significant. Therefore, the trial was prematurely stopped in order to allow patients receiving chemotherapy to cross over to the pembrolizumab arm. At second interim analysis, pembrolizumab showed a significant superior progression-free survival (PFS) and OS if compared with standard chemotherapy, meeting the primary objective of the trial. Three-hundreds and five patients out of 500 were randomized to receive pembrolizumab (n=154) or platinum-based chemotherapy (n=151). ![]() In the first-line setting, the open-label, randomized, phase III KEYNOTE-024 trial, showed that pembrolizumab was more effective if compared with platinum-based chemotherapy in NSCLC patients with high levels of PD-L1 expression ( 6).įive hundred (30.2%) out of tumor samples from 1,653 patients were strongly positive for PD-L1 expression (TPS ≥50%).
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