The US Food and Drug Administration (hereinafter referred to as FDA) approved Portrazza (necitumumab) in combination with gemcitabine and cisplatin in the treatment of advanced (metastatic) squamous non-small cell lung cancer on November 24, 2015, becoming the first Approved for first-line treatment of patients with advanced squamous non-small cell lung cancer.
Lung cancer is currently the malignant tumor with the highest morbidity and mortality, with more than 1 million deaths due to lung cancer worldwide each year. According to clinical and histopathological characteristics, lung cancer can be roughly divided into two types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which non-small cell lung cancer accounts for about 85% of all lung cancers. Non-small cell lung cancer can be further divided into squamous and non-squamous non-small cell lung cancer, which includes lung adenocarcinoma. Squamous non-small cell lung cancer accounts for about 30% of all lung cancers. The prognosis of patients is poor, and the 5-year survival rate is less than 5%. The research and treatment of squamous NSCLC lags far behind lung adenocarcinoma. One of the important reasons is that there are too few driving gene markers known to help make clinical treatment decisions. The targeted treatment of lung squamous cell carcinoma faces difficulties and challenges . Because of the greater risk of pulmonary hemorrhage, bevacizumab is not recommended for lung squamous cell carcinoma. Due to economic utility considerations, cetuximab is also limited. As of now, its first-line treatment still has huge medical needs.
At present, the first-line treatment plan for the treatment of squamous non-small cell lung cancer at home and abroad is platinum-containing two-drug chemotherapy (studies have confirmed that cisplatin combined with gemcitabine is more effective), and the second-line treatment abroad is docetaxel or docetaxel combined with a new target Xiang, immunotherapy drugs nivolumab and ramucirumab. Among them, nivolumab is the immunotherapy drug OPDIVO (PD-1 inhibitor), and ramucirumab is an anti-vascular endothelial growth factor (VEGF) inhibitor. These targeted drugs are not listed in the country. This time, Portrazza was approved for use in combination with gemcitabine and cisplatin, becoming the first targeted drug approved for first-line treatment of patients with advanced squamous non-small cell lung cancer.
Necitumumab (trade name: Portrazza) is a human recombinant IgG1 monoclonal antibody of EGFR. EGFR (epidermal growth factor receptor) is a multifunctional glycoprotein widely distributed on the cell membrane of various tissues of the human body. It is a tyrosine kinase Type receptor is one of the four members of the HER / ErbB family, and its mutation or overexpression is associated with malignant phenotypes such as malignant proliferation, inhibition of apoptosis, local infiltration, vascularization, and tumor metastasis of tumor cells.
Necitumumab’s safety and effectiveness study was seen in a first-line multi-center, randomized, open phase III clinical trial SQUIRE, which included 1,093 patients with advanced squamous non-small cell lung cancer. The patients were randomly divided into two groups and received Gemcitabine + cisplatin + Necitumumab (GP regimen combined with Necitumumab) and gemcitabine + cisplatin therapy alone (GP regimen alone).
The results suggest that GP combined with necitumumab treatment group has significantly improved overall survival (HR 0.84; 95% CI: 0.74-0.96; p = 0.01) compared with GP chemotherapy alone group, and the median survival time of patients is 11.5 months (95 % CI: 10.4-12.6), and the survival time of the gemcitabine + cisplatin two-drug group was 9.9 months (95% CI: 8.9-11.1), and the risk of death was reduced by 16% in the three-drug combination group, and the median of the two groups did not progress The survival periods were 5.7 vs 5.5 months. However, necitumumab is not effective for the treatment of patients with non-squamous non-small cell lung cancer.
The most common side effects of Necitumumab include rash and hypomagnesemia, which in turn cause muscle weakness, epilepsy, irregular heartbeat, etc. Sudden cardiac arrest and sudden death may also occur, so the prescribing doctor needs to pay special attention.
Dr. Richard Pazdur, head of the Department of Hematology and Oncology Products at the FDA’s Center for Drug Evaluation and Research, said: “The types of lung cancer vary greatly, so the choice of treatment depends on the type of patient. Portrazza approved today is lung squamous cell carcinoma A new option for patients to prolong survival. “
Necitumumab (trade name: Portrazza) is marketed by Eli Lilly and Company of the United States. The nivolumab (trade name: OPDIVO, approved for the treatment of squamous non-small cell lung cancer on June 22, 2015) mentioned in the article belongs to Bristol-Myers Squibb, ramucirumab (Trade name: Cyramza, approved for the treatment of squamous non-small cell lung cancer on April 21, 2014) It is also a product of Eli Lilly of the United States. These three drugs are not listed in the country.