#KEYNOTE 024 TRIAL PLUS#
In the Keynote-189 trial, 616 patients with previously untreated metastatic non-squamous NSCLC without sensitizing EGFR mutations or ALK translocations were randomized in a 2:1 ratio to receive platinum (carboplatin or cisplatin) plus pemetrexed and either pembrolizumab 200 mg or placebo every 3 weeks ( 12). Two subsequent trials expanded the use of pembrolizumab in the first-line setting.
In the updated report, the median OS for patients treated with pembrolizumab and chemotherapy were 30.0 and 14.2 months respectively (HR 0.63 95% CI: 0.47–0.86) ( 11). 53.3%), establishing it as a new standard of care for this patient population. 90.0%) and grade 3 or higher treatment-related adverse events (26.6% vs. 27.8%), median PFS and estimated survival at 6 months (80.2% vs. Pembrolizumab was associated with improved response rate (44.8% vs. In the Keynote-024 trial, 305 patients with previously untreated advanced NSCLC, PD-L1 expression of ≥50% and no sensitizing mutation of the epidermal growth factor receptor ( EGFR) gene or translocation of the anaplastic lymphoma kinase ( ALK) gene, were randomized to receive either pembrolizumab at 200 mg every 3 weeks or a choice of platinum-based chemotherapy, with crossover from the chemotherapy group to pembrolizumab allowed at the time of tumor progression ( 10). Therefore, the next logical step was to evaluate the role of pembrolizumab in previously untreated patients with PD-L1 score of ≥50%, where the efficacy was comparable to historical data on first-line platinum-based combination chemotherapy with or without maintenance chemotherapy ( 6- 9). in the phase 1 study with the anti-PD-1 antibody pembrolizumab in previously treated NSCLC, the response rate and median progression-free survival (PFS) for patients with PD-L1 proportion score of ≥50% were 45.2% and 6.3 months respectively, with median PFS of 6.1 months for the 99 previously treated patients and 12.5 months for the 20 previously untreated patients ( 5).
Immunotherapy with monoclonal antibodies against programmed death-1 (PD-1) or its ligand (PD-L1) were approved for previously treated advanced non-small cell lung cancer (NSCLC) based on the results from four randomized trials showing improved survival compared to standard therapy with docetaxel ( 1- 4).
0 kommentar(er)
