Nivolumab BMS (nivolumab) is indicated in locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) in patients who have previously received chemotherapy.
Nivolumab is a human monoclonal antibody that binds to the programmed death-1 (PD-1) receptor and blocks its interaction with the ligands PD-L1 and PD-L2 on antigen presenting and tumour cells. This blockade potentiates T-cell responses, including anti-tumour responses. PD-1 inhibitors belong to a new class of cancer immunotherapies known as checkpoint inhibitors. Nivolumab is already launched as Opdivo for melanoma.
In the CheckMate 017 study in patients with advanced squamous NSCLC (n=272), median overall survival was 9.2 months (95% CI 7.3–13.3) with nivolumab 3mg/kg versus 6.0 months (95% CI 5.1–7.3) with docetaxel 75mg/m2. At 1 year, the overall survival rate was 42% (95% CI 34–50) with nivolumab and 24% (95% CI 17–31) with docetaxel. Response rate and progression-free survival were also significantly better with nivolumab than docetaxel.
The most frequent adverse effects of nivolumab were fatigue (33%), decreased appetite (15%) and nausea (12%). Nivolumab has been associated with immune-related adverse reactions. Patients should be monitored continuously for such reactions and for at least 5 months after the last dose, as these can occur at any time during or after discontinuation of therapy.
Prescribers must familiarise themselves with the Physician Information and Management Guidelines and discuss the risks of nivolumab therapy with their patients. A Patient Alert Card should be issued with each prescription.
NICE is currently developing guidance for nivolumab use in NSCLC.