Nivolumab Produces Durable Responses in Advanced Melanoma

Nivolumab, an investigational, anti–PD-1 drug, produced durable responses in patients with advanced melanoma, according to the results of a study published in the Journal of Clinical Oncology.

Of the more than one million new diagnoses of skin cancer each year, roughly 76,000 involve melanoma. More than 9,000 people die of melanoma each year in the United States. Melanoma is dangerous because it is more likely than other types of skin cancer to spread (metastasize) to other parts of the body.

PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1 may enhance the ability of the immune system to fight cancer. Nivolumab works by blocking PD-1.

In this study, 107 patients with advanced melanoma received nivolumab intravenously every two weeks in an outpatient setting in 8-week treatment cycles. Patients continued treatment for up to 96 weeks and were observed for overall survival, long-term safety, and response duration after treatment discontinuation.

Median overall survival was 16.8 months. The one-year survival rate was 62 percent and the two-year survival rate was 43 percent. The objective response rate was 31 percent. Among the 33 patients with objective response, the median duration of response was two years.

Seventeen patients discontinued therapy for reasons other than disease progression and 12 of these patients maintained responses off therapy for 16 or more weeks.

The maximum-tolerated dose of nivolumab was not reached. The most common adverse events of any grade were fatigue, rash, and diarrhea. Grade 3 or 4 treatment-related adverse events occurred in 22 percent of patients, with the most common being lymphopenia and fatigue, diarrhea, and abdominal pain.

The researchers concluded that nivolumab produced durable responses that persisted after drug discontinuation. Long-term follow-up showed promising survival rates and acceptable toxicity.


Topalian SL, Sznol M, McDermott DF, et al: Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab. Journal of Clinical Oncology. Published early online March 3, 2014. doi: 10.1200/JCO.2013.53.0105

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