Long term evaluation of the new immunotherapy Nivolumab

The current study examined long-term response and survival among advanced melanoma patients treated with the immunotherapy agent nivolumab.

Immunotherapies can stimulate the immune system to identify and destroy cancer cells, much in the same way it would fight invaders such as bacteria or viruses. Some cancer cells, however, are able to suppress the immune response by stimulating certain immune pathways or receptors. Immunotherapies which target these points, such as ipilimumab (Yervoy), have been found to improve survival in some melanoma patients. A new immunotherapy, nivolumab, blocks the known immune cell suppressor programmed cell death 1 (PD-1). Nivolumab has been found to cause tumor regression in 20% to 30% of patients treated in earlier clinical trials. The current study examined the long-term response and survival of melanoma patients treated with nivolumab.

In this study, 107 advanced melanoma patients received nivolumab every 2 weeks for up to 96 weeks. The dose of nivolumab was increased over time. Following each 8 week treatment cycle, tumor size, disease response and rate of toxicities were measured. Patients were followed for up to 4 years following treatments.

On average, overall survival was 16.8 months. Overall 1-year survival rate was 62%, and 2-year survival rate was 43%. Progression-free survival (the time before melanoma progression) was greater than 1 year in 36% of patients, and beyond 2 years in 27% of patients. An objective response to treatment (a decrease in tumor size) was noted in 31% of patients. Among these patients, 58% were still exhibiting a good response to treatment at the end of the study period.

All doses tested were safe and well-tolerated. The most common side effects seen were fatigue (32% of patients), rash (23% of patients) and diarrhea (18% of patients). These effects were most often seen in the first 6 months of treatment.

This study concluded that the PD-1 blocking agent nivolumab can lead to rapid response, delayed disease progression and extended survival among advanced melanoma patients.

Discuss the risks and benefits of immunotherapies such as nivolumab with your physician.