Bristol-Myers' Opdivo cleared in Europe for kidney cancer

Bristol-Myers’ Opdivo cleared in Europe for kidney cancer

The European Commission has approved new indications for the immunotherapy nivolumab (Opdivo, Bristol-Myers Squibb), expanding its use in the treatment of non-small-cell lung cancer (NSCLC), and adding the indication of renal cell carcinoma (RCC).
The drug is already approved in Europe for use in previously treated patients with metastatic squamous NSCLC. Now the indication has been expanded to include non-squamous NSCLC, which represents 85% of the cases of lung cancer, and monotherapy in locally advanced or metastatic disease.
Nivolumab is the only PD-1 inhibitor that has been approved for a broad range of patients with previously treated metastatic NSCLC, regardless of PD-L1 expression, and nivolumab is the only approved PD-1 inhibitor to demonstrate a better overall survival rate than docetaxel in previously treated metastatic NSCLC, the manufacturer pointed out in a press release.
“As the only approved PD-1 inhibitor proven to have demonstrated a survival benefit, compared with a standard of care, regardless of PD-L1 expression, healthcare providers can offer treatment with nivolumab to appropriate patients who have received previous chemotherapy without the need to first conduct biomarker testing to determine PD-L1 expression,” Luis Paz-Ares, MD, from Hospital Universitario Doce de Octubre in Madrid, said in the press release.
The approval is based on results from the phase 3 CheckMate-057 trial, an open-label randomized study that compared nivolumab with docetaxel in patients with metastatic non-squamous NSCLC.
Patients were randomized to receive nivolumab 3 mg/kg administered intravenously every 2 weeks or docetaxel 75 mg/m² administered intravenously every 3 weeks. A prespecified interim analysis was conducted when 413 events were observed (93% of the planned number of events for final analysis).
Nivolumab demonstrated better overall survival than docetaxel, with a 27% reduction in the risk for death (hazard ratio [HR], 0.73; P = .0015). The 1-year survival rate was 51% for nivolumab and 39% for docetaxel.
The median overall survival was 12.2 months with nivolumab and 9.4 months with docetaxel. The objective response rate was 19% with nivolumab (56/292; four complete responses, 52 partial responses) and 12% with docetaxel (36/290; one complete response, 35 partial responses; P = .0246).
The median duration of response was 17.2 months with nivolumab and 5.6 months with docetaxel, and median progression-free survival was 2.3 months and 4.2 months, respectively (HR, 0.92; P = .3932).
Read the full article on MedScape here