Although first-line treatment with necitumumab in combination with gemcitabine + cisplatin in the SQUIRE study achieved only a 1.6-month improvement in OS and a 0.2-month improvement in PFS in locally progressive or metastatic squamous NSCLC, the FDA approved necitumumab in combination with gemcitabine + cisplatin as first-line treatment for patients with locally progressive or metastatic squamous NSCLC based on this study. NSCLC patients as first-line therapy. The FDA recently approved necitumumab (Portrazza, Eli Lilly) in combination with gemcitabine and cisplatin for the first-line treatment of locally progressive or metastatic squamous non-small cell lung cancer (NSCLC) based on the results of the Phase III clinical trial SQUIRE. Data from 1,093 patients in the study showed that a regimen of gemcitabine and cisplatin with the fully human IgG1 EGFR monoclonal antibody necitumumab (NECITU monoclonal antibody) improved overall survival (OS) by 1.6 months, equating to a 16% reduction in the risk of death. The three-drug regimen also increased PFS rates by 15 percent. The FDA made this approval based on an informal recommendation published by the Drugs in Cancer Advisory Committee (ODAC) in July 2015. The panel hit consensus after a discussion of the SQUIRE study results: despite the statistically significant results obtained, the benefit of NECITU monoclonal antibody was not outstanding. ”Lung cancer cells are capable of many changes, so treatment options should also be tailored to specific types of lung cancer patients,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, describing the approval, “This approval provides specific squamous cell lung cancer patients with a new treatment option that has the potential to improve overall survival.” In the Phase III clinical trial SQUIRE study, patients were randomized to receive gemcitabine + cisplatin + NECITU monotherapy (study group, n=545)/placebo (control group, n=548). 800 mg of NECITU was given on days 1 and 8 every 3 weeks. 1250 mg/m2 was given on days 1 and 8 for gemcitabine and 75 mg/m2 on day 1 for cisplatin in both arms. Patients in the study group who responded continued to receive single-agent NECITU monotherapy. The basic patient characteristics were similar between the two groups. The median age was 62 years, the predominant patient population was white (84%), the majority of patients had a history of smoking (91%), and the most common metastases were to the lungs (83%). The primary endpoint of the study was OS, with secondary endpoints of PFS and objective remission rate (ORR). After nearly 25 months of follow-up, median OS in the study group vs. control group (below) was 11.5 months vs. 9.9 months (HR=0.84; 95% CI 0.74-0.96; P=0.012). 1-year OS rate: 48% vs. 43%; 2-year OS rate: 20% vs. 17%. Median PFS: 5.7 months vs. 5.5 months (HR=0.85; 95% CI 0.74-0.98; P=0.02); 6-month PFS rate: 45% vs. 37%. ORR: 31% vs. 29% (P=0.40); disease control rate (ORR+stable disease): 82% vs. 77% (P=0.043); median time to treatment failure: 4.3 months vs. 3.6 months. Grade 3 and above adverse events (AEs) occurred in 72% vs. 62%. Grade 3 and above AEs were significantly more frequent in the study group: hypomagnesemia (9% vs. 1%), rash (4% vs. <1%), and venous thrombosis (5% vs. 3%). Incidence of severe AE: 48% vs. 38%. incidence of AE leading to treatment interruption 31% vs. 25%. mortality after AE: 12% vs. 11%. In an update of the study data at the ASCO 2015 Annual Meeting, study first author Dr. Martin Reck, leader of the Department of Thoracic Oncology at Grosshansdorf Hospital, said, "The SQUIRE study is the largest sample size study of advanced squamous cell carcinoma reported to date, and our current treatment options for advanced squamous cell carcinoma are really very There are very limited treatment options for advanced squamous cell carcinoma. We observed an improvement in OS and PFS with the combination of NECITU monoclonal antibody."