Nivolumab Monotherapy Induces Durable, Long-term Survival in Advanced Melanoma

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).

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.

“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.

Reference

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.