Nivolumab ( Opdivo ) is a PD-1 immune checkpoint inhibitor. The MAA submitted to the EMA ( European Medicine Agency ) in lung cancer is based on data from the phase 2 study ( Study-063 ) of Nivolumab in third-line pre-treated non-small cell lung cancer ( NSCLC ) ( squamous cell carcinoma ).
Cancer cells may exploit regulatory pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack.
Nivolumab is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 ( programmed death-1 ) expressed on activated T-cells.
Bristol-Myers Squibb ( BMS ) has a broad, global development program to study Nivolumab in multiple tumor types consisting of more than 35 trials, as monotherapy or in combination with other therapies, in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in cell non-small cell lung ( NSCLC ), melanoma, renal cell carcinoma ( RCC ), head and neck cancer, glioblastoma and non-Hodgkin lymphoma.
Lung cancer is the leading cause of cancer deaths globally, resulting in more than 1.5 million deaths each year according the World Health Organization.
NSCLC is one of the most common types of the disease and accounts for approximately 85% of cases.
Survival rates vary depending on the stage and type of the cancer when it is diagnosed. Globally, the five-year survival rate for stage I NSCLC is between 47 and 50%; for stage IV NSCLC, the five-year survival rate drops to 2%. ( Xagena )
Source: BMS, 2014