After 5 years of follow-up, 34% of patients with advanced melanoma who participated in a phase 1 clinical trial are still alive after receiving nivolumab treatment, a study presented at the American Academy for Cancer Research (AACR) Annual Meeting 2016 has shown.1

For the study, which was initiated in 2008, researchers enrolled 107 patients who had received up to 5 prior treatments, but not ipilimumab. All participants received nivolumab at 1 of 5 doses, including the subsequently recommended dose of 3 mg/kg every 2 weeks, for up to 2 years. Results published in the Journal of Clinical Oncology in 2014 showed that some patients who achieved a response had durable responses that persisted after nivolumab discontinuation.

Those 107 patients were followed for up to 5 years from the time each patient received his or her first dose of nivolumab. Updated results showed that the 60-month overall survival rate was 34% (95% CI, 25-43) and a median overall survival of 17.3 months (95% CI, 12.5-37.8).

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For patients who received the approved dose of 3 mg/kg every 2 weeks, median overall survival was 20.3 months. Progression-free survival rates at 30 months were 18.6% for all patients and 25.7% for patients who received the 3 mg/kg dose.

Researchers also found that overall survival rates appeared to plateau at approximately 48 months, but further follow-up is necessary to confirm this finding.

“The five-year OS in all 107 patients was 34%, and OS rates appeared to plateau at around 48 months, which is indicative of long-term benefit in some patients, although more follow-up is needed to fully appreciate the benefit of nivolumab monotherapy,” said lead author F. Stephen Hodi, MD, director of the Melanoma Center at Dana-Farber Cancer Institute, associate professor of medicine and investigator at the Ludwig Center at Harvard Medical School in Boston, MA.

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“This is the first long-term follow-up analysis of data from a clinical trial testing an anti-PD-1 immunotherapy, and it is very encouraging that a subset of melanoma patients is experiencing a long-term survival benefit,” said Dr Hodi.

Nivolumab is a human IgG4 anti-programmed death-1 monoclonal antibody approved by the U.S. Food and Drug Administration for the treatment of advanced melanoma, kidney cancer, and non-small cell lung cancer. It is also being studied in patients with glioblastoma, head and neck cancer, liver cancer, and a variety of hematologic malignancies.


  1. Hodi FS, Kluger H, Sznol M, et al. Durable, long-term survival in previously treated patients with advanced melanoma (MEL) who received nivolumab (NIVO) monotherapy in a phase I trial. Oral presentation at: AACR Annual Meeting 2016; April 16-20, 2016; New Orleans, LA.