Nivolumab Plus Ipilimumab Shows Long-Term Survival in Patients With Advanced Melanoma

Source: Targeted Oncology, October 2019

Long-term follow-up results from CA209-004, a phase I study analyzing patients with advanced, unresectable melanoma treated with nivolumab (Opdivo) plus ipilimumab (Yervoy), showed favorable survival outcomes at the 5-year mark.

For the analysis, patients who were previously treated or untreated were enrolled and separated into5 cohorts. Each cohort received different doses of nivolumab and ipilimumab. The survival exploratory endpoint was analyzed for 3 years, while the primary and secondary endpoints of safety, response, and progression-free survival, were followed for 2.5 years.

The median follow-up was 43.1 months across all 4 cohorts (n = 94), at 4 years or longer. At both 4 years and 4.5 years, the overall survival (OS) rate was 57% (95% CI, 47%-67%). The was a difference in OS in patients with a normal lactate dehydrogenase (LDH; 62%) versus those with an elevated LDH (49%). OS also differed based on the presence of a gene mutation. Patients with BRAF-mutated tumors showed a 4-year OS rate of 61%, while those with BRAF wild-type tumors showed an OS rate of 54%.¹