As reported in the Journal of Clinical Oncology by González-Martín et al, a phase III trial (ENGOT-OV41/GEICO 69-O/ANITA) has shown no progression-free survival benefit with the addition of atezolizumab to a carboplatin doublet and maintenance niraparib in patients with recurrent ovarian cancer with a platinum-free interval > 6 months.
Study Details
In the European double-blind multicenter trial, 417 patients who had received one or two previous chemotherapy lines, with the most recent including a platinum, were randomly assigned between November 2018 and January 2022 to receive atezolizumab (n = 208) or placebo (n = 209) in combination with a prerandomization investigator-selected platinum doublet (carboplatin with paclitaxel, gemcitabine, or pegylated liposomal doxorubicin) for six cycles, and niraparib maintenance among patients with objective response or stable disease. The primary endpoint was investigator-assessed progression-free survival.
Key Findings
Median follow-up was 28.6 months (95% confidence interval [CI] = 26.6–30.5 months). Median progression-free survival was 11.2 months (95% CI = 10.1–12.1 months) in the atezolizumab group vs 10.1 months (95% CI = 9.2–11.2 months) in the control group (hazard ratio [HR] = 0.89, 95% CI = 0.71–1.10, P = .28). Outcomes were generally similar among subgroups, including PD-L1–expression subgroups.
Among 306 patients starting maintenance therapy, median maintenance progression-free survival was 6.7 months with atezolizumab/niraparib vs 5.3 months with placebo/niraparib (HR = 0.80, 95% CI = 0.62–1.03). Objective response rates were 45% vs 43%. An additional 44% vs 46% of patients had stable disease.
Treatment-related grade ≥ 3 adverse events occurred in 65% vs 63% of patients. Serious adverse events were observed in 37% vs 30%. A stated by the investigators, “The safety profile was as expected from previous experience of these drugs.”
The investigators concluded; “Combining atezolizumab with [chemotherapy] and maintenance niraparib for late-relapsing recurrent ovarian cancer did not significantly improve [progression-free survival] or the [objective response rate].”
Antonio González-Martín, MD, of Cancer Center Clínica Universidad de Navarra, Madrid, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was funded by F. Hoffmann-La Roche Ltd and GlaxoSmithKline. For full disclosures of the study authors, visit ascopubs.org.
