In a nutshell
This study investigated the effect of nivolumab (Opdivo) combined with ipilimumab (Yervoy) in overall survival in the treatment of advanced melanoma. Researchers suggested that this combination is associated with an improved survival when compared to ipilimumab alone.
Some background
Advanced melanoma is associated with a poor survival, with an average overall survival of about 8 months. Newer treatments, such as PD-1 inhibitors (nivolumab), have been shown to have a superior effect on survival when compared to ipilimumab alone. Prior studies found that nivolumab in combination with ipilimumab is associated with longer progression-free survival (time from treatment to disease progression) and improved treatment response than ipilimumab alone.
Methods & findings
The objective of this study was to investigate 2-year overall survival (time from treatment to death by any cause) of patients with advanced melanoma treated this combined treatment.
This study included 142 patients with inoperable stage 3 and 4 melanoma. Patients were randomly assigned to receive the combined treatment (95 patients) or ipilimumab plus placebo (substance with no effect on the body) (47 patients) every 3 weeks for 4 doses. The average follow-up period was 24.5 months.
2-year overall survival was 63.8% for the combination group and 53.6% for the ipilimumab alone group. Negative side effects were seen in 54% of patients in the combination group and in 20% of the patients in the ipilimumab alone group. Severe side effects included inflammation of the colon (colitis) in 11% of patients of the combination group and diarrhea in 4% of patients in the ipilimumab group.
The bottom line
This study suggested that combination of nivolumab with ipilimumab is associated with an improved 2-year overall survival in patients with advanced melanoma, when compared with ipilimumab alone.
The fine print
This trial was funded by Bristol-Myers Squibb, the manufacturer of nivolumab.
Published By :
The Lancet. Oncology
Date :
Sep 09, 2016