The following is a summary of “Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma,” published in the November 2024 issue of Oncology by Long et al.
Patients with advanced melanoma who have not previously received immune checkpoint inhibitors (ICI) often experience lasting clinical benefits with nivolumab (NIVO) and ipilimumab (IPI) combination therapy or NIVO monotherapy.
Researchers conducted a retrospective study to assess long-term survival outcomes and clinical factors associated with survival in patients with advanced melanoma receiving either NIVO + IPI or NIVO alone.
They pooled data from 6 CheckMate studies in ICI treatment–naïve patients with advanced melanoma who received NIVO + IPI (either NIVO 1 mg/kg + IPI 3 mg/kg or NIVO 3 mg/kg + IPI 1 mg/kg) or NIVO monotherapy (3 mg/kg). Treatment and specific subgroups assessed overall survival (OS), with Cox proportional multivariate analysis and classification and regression tree (CART) analyses performed within treatment arms.
The results showed a median OS follow-up of 45.0 months for NIVO + IPI (n = 839) and 35.8 months for NIVO alone (n = 536), OS was longer with NIVO + IPI compared with NIVO monotherapy (HR, 0.78 [95% CI, 0.67 to 0.91]), and 6-year OS rates were 52% for NIVO + IPI vs. 41% for NIVO alone. Consistent survival benefits were observed in patients with both BRAF mutations and BRAF wild-type, and in patients with normal or elevated lactate dehydrogenase (LDH). The OS advantage was more notable in patients with low or no programmed death-ligand 1 (PD-L1) expression. Factors associated with decreased survival included LDH levels above the upper limit of normal with both treatments, age ≥65 years with NIVO + IPI, and the presence of liver metastases with NIVO monotherapy.
They concluded that NIVO + IPI provided a longer OS than NIVO alone in patients with advanced melanoma, identifying specific clinical factors associated with survival that may guide treatment choices.