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Keynote 0246/4/2023 ![]() ![]() Nivolumab was shown to improve overall survival (OS) compared to second-line docetaxel in CheckMate 057, a randomized phase 3 study of 292 patients with advanced nonsquamous NSCLC who progressed during or after platinum-based doublet chemotherapy (median OS 12.2 vs. Further studies demonstrated that targeting the programmed death 1 (PD-1) and programmed death ligand 1 (PD-L1) axis using fully humanized IgG4 monoclonal antibodies against PD-1 (pembrolizumab, nivolumab) or PD-L1 (atezolizumab) was more effective than chemotherapy in first-line metastatic melanoma, second-line advanced renal cell carcinoma, second-line advanced nonsquamous NSCLC, recurrent or metastatic squamous cell carcinoma of the head and neck, and had significant responses in second-line advanced urothelial carcinoma and refractory classical Hodgkin lymphoma. The first approved checkpoint inhibitor was ipilimumab, a monoclonal antibody targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4), in the treatment of melanoma. These agents improve the ability of the immune system to recognize and kill tumor cells. Recent years have seen the approval of immune checkpoint inhibitors for the treatment of multiple malignancies. Patients with untreated advanced NSCLC with PD-L1 expression ≥50% had longer progression-free and overall survival with pembrolizumab over platinum-based chemotherapy with fewer adverse events. Among patients with untreated advanced non-small-cell lung cancer (NSCLC) with PD-L1 expression and without EGFR mutations or ALK rearrangements, does pembrolizumab improve progression-free survival compared to platinum-based chemotherapy? ![]()
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