Nivolumab Alone versus In Combination with Ipilimumab in Recurrent or Persistent Ovarian Cancer: How Do These Treatments Compare?

A randomized phase 2 trial compared outcomes for patients with persistent or recurrent epithelial ovarian cancer (EOC) taking standalone nivolumab versus in combination with ipilimumab.

Women were eligible for study inclusion if they had measurable disease, one to three prior regimens, and platinum-free interval (PFI) <12 months. Patients were randomized to intravenous nivolumab every two weeks or induction with nivolumab plus ipilimumab for four doses every three weeks, followed by maintenance nivolumab every two weeks for a maximum of 42 doses.

Final analysis included 100 patients: 49 in the nivolumab alone arm, and 51 in the nivolumab plus ipilimumab arm. Most patients (62%) had a PFI of <6 months. In the nivolumab alone group, six responses (12.2%) occurred within six months, compared to 16 (31.4%) in the nivolumab plus ipilimumab group (odds ratio=3.28; 95% confidence interval [CI], 1.54 to infinity; P=0.034). The nivolumab plus ipilimumab group had longer median progression-free survival than the nivolumab alone group (3.9 months vs. 2 months); the PFI-stratified hazard ratio was 0.53 (95% CI, 0.34 to 0.82), and the respective hazard ratio for death was 0.79 (95% CI, 0.44 to 1.42). About a third of nivolumab alone patients experienced grade ≥3 related adverse events, compared to 49% in the combination group; no treatment-related deaths were reported. In both groups, there was no significant correlation between PD-L1 expression and response.

The study results were published in the Journal of Clinical Oncology.

“Compared with nivolumab alone, the combination of nivolumab and ipilimumab in EOC resulted in superior response rate and longer, albeit limited, PFS, with toxicity of the combination regimen comparable to prior reports. Additional combination studies to enhance durability of the dual regimen are warranted,” the researchers said in summary.

Ovarian Cancer News

Last year, a randomized trial analyzed the efficacy of veliparib as an add-on to first-line induction chemotherapy with carboplatin and paclitaxel in patients with newly diagnosed late-stage ovarian cancer.

Overall, 1,140 patients were randomized. Median progression-free survival in the BRCA-mutation cohort was 34.7 months in the veliparib-throughout group, compared to 22.0 months in the control group (hazard ratio [HR] for progression or death=0.44; 95% confidence interval [CI], 0.28-0.68; P<0.001). Progression-free survival in the HRD cohort was 31.9 months in the veliparib-throughout group versus 20.5 in the control group (HR=0.57; 95%CI, 0.43-0.76; P<0.001). In the intention-to-treat population, progression-free survival was 23.5 months in the veliparib-throughout group versus 17.3 months in the control group (HR=0.68; 95% CI, 0.56-0.83; P<0.001). Veliparib in combination with chemotherapy was associated with a higher incidence of anemia and thrombocytopenia, and a higher prevalence of nausea and fatigue.