Avelumab, given in combination with chemotherapy or as maintenance, did not improve progression-free survival (PFS) over chemotherapy alone in patients with previously untreated, advanced epithelial ovarian cancer, according to phase 3 results published in The Lancet Oncology.
The phase 3 JAVELIN Ovarian 100 trial (ClinicalTrials.gov Identifier: NCT02718417) included 998 adult patients with stage III-IV epithelial ovarian, fallopian tube, or peritoneal cancer.
Patients were randomly assigned to receive chemotherapy plus avelumab maintenance (n=332), chemotherapy plus concomitant avelumab followed by avelumab maintenance (n=331), or chemotherapy alone (n=335).
Chemotherapy consisted of 6 cycles of carboplatin (dosed at an area under the serum concentration-time curve of 5 or 6 every 3 weeks) plus paclitaxel (given at 175 mg/m² every 3 weeks or 80 mg/m² once a week).
When given with chemotherapy, the avelumab dose was 10 mg/kg every 3 weeks. When given as maintenance, the dose was 10 mg/kg every 2 weeks.
The primary endpoint was PFS. The trial was terminated early at the first interim analysis due to futility.
At a median follow-up of 10.8 months, the median PFS was similar across the treatment groups. The median PFS was not estimable with chemotherapy alone, 16.8 months with avelumab maintenance (hazard ratio [HR], 1.43; 95% CI, 1.05-1.95; P =.99), and 18.1 months with combination avelumab (HR, 1.14; 95% CI, 0.83-1.56; P =.79).
Serious adverse events were more common in the avelumab combination group (36%) than in the avelumab maintenance group (28%) or the chemotherapy-only group (19%).
“Although no new safety signals were observed, results do not support the use of avelumab in the frontline treatment setting,” the study authors wrote. “Alternative treatment regimens are needed to improve outcomes in patients with advanced epithelial ovarian cancer.”
Disclosures: This research was supported by Pfizer and Merck. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Monk BJ, Colombo N, Ozo AM, et al. Chemotherapy with or without avelumab followed by avelumab maintenance versus chemotherapy alone in patients with previously untreated epithelial ovarian cancer (JAVELIN Ovarian 100): An open-label, randomised, phase 3 trial. Lancet Oncol. Published August 4, 2021. doi:10.1016/S1470-2045(21)00342-9