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Ref Type Journal Article
PMID (27718847)
Authors Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR, null null
Title Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer.
Journal Vol Issue Date Pages Journal Short Title
The New England journal of medicine 375 19 2016 11 10 1823-1833 N Engl J Med
URL
Abstract Text Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1).In this open-label, phase 3 trial, we randomly assigned 305 patients who had previously untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene to receive either pembrolizumab (at a fixed dose of 200 mg every 3 weeks) or the investigator's choice of platinum-based chemotherapy. Crossover from the chemotherapy group to the pembrolizumab group was permitted in the event of disease progression. The primary end point, progression-free survival, was assessed by means of blinded, independent, central radiologic review. Secondary end points were overall survival, objective response rate, and safety.Median progression-free survival was 10.3 months (95% confidence interval [CI], 6.7 to not reached) in the pembrolizumab group versus 6.0 months (95% CI, 4.2 to 6.2) in the chemotherapy group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.37 to 0.68; P<0.001). The estimated rate of overall survival at 6 months was 80.2% in the pembrolizumab group versus 72.4% in the chemotherapy group (hazard ratio for death, 0.60; 95% CI, 0.41 to 0.89; P=0.005). The response rate was higher in the pembrolizumab group than in the chemotherapy group (44.8% vs. 27.8%), the median duration of response was longer (not reached [range, 1.9+ to 14.5+ months] vs. 6.3 months [range, 2.1+ to 12.6+]), and treatment-related adverse events of any grade were less frequent (occurring in 73.4% vs. 90.0% of patients), as were grade 3, 4, or 5 treatment-related adverse events (26.6% vs. 53.3%).In patients with advanced NSCLC and PD-L1 expression on at least 50% of tumor cells, pembrolizumab was associated with significantly longer progression-free and overall survival and with fewer adverse events than was platinum-based chemotherapy. (Funded by Merck; KEYNOTE-024 ClinicalTrials.gov number, NCT02142738 .).

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
CD274 over exp lung non-small cell carcinoma predicted - sensitive Pembrolizumab Phase III Actionable In a Phase III trial (KEYNOTE-024), treatment with Keytruda (pembrolizumab) improved progression-free survival (10.3 vs 6.0 months, HR=0.50, p<0.001) and estimated 6-month overall survival rate (80.2% vs 72.4%, HR=0.60, p<0.001) compared to chemotherapy in untreated advanced non-small cell lung cancer patients with CD274 (PD-L1) expression on over 50% of tumor cells, and with no EGFR activating mutations or ALK rearrangement (PMID: 27718847; NCT02142738). 27718847
CD274 positive lung non-small cell carcinoma sensitive Pembrolizumab FDA approved - On Companion Diagnostic Actionable In a Phase II/III trial (KEYNOTE-010) that supported FDA approval, treatment with Keytruda (pembrolizumab) resulted in improved overall survival (10.4 months at 2mg/kg, 12.7 months at 10mg/kg, vs 8.5 months) compared to chemotherapy in previously treated non-small cell lung cancer patients with CD274 (PD-L1) expression in over 1% of tumor cells (PMID: 26712084, PMID: 27026676, PMID: 27718847; NCT01905657). 26712084 27026676 27718847 detail...