A randomized phase 3 trial designed to evaluate avelumab for women with previously untreated advanced ovarian cancer failed to achieve its primary endpoint of PFS.
The JAVELIN Ovarian 100 study has been terminated based on the finding, reported as part of a planned interim analysis.
Avelumab (Bavencio; EMD Serono, Pfizer) — a human anti-PD-L1 antibody — is approved for adults and children aged 12 years or older with metastatic Merkel cell carcinoma, as well as certain patients with locally advanced or metastatic urothelial carcinoma.
The JAVELIN Ovarian 100 study evaluated avelumab in combination with or after platinum-based chemotherapy among women with treatment-naive ovarian cancer. Eighty percent of ovarian cancer cases are diagnosed at advanced stages, and most women with advanced disease die within 5 years.
The multicenter study included 998 women with previously untreated, locally advanced or metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer.
Researchers randomly assigned women to one of three treatment regimens: carboplatin/paclitaxel followed by observation; carboplatin/paclitaxel followed by avelumab maintenance; or avelumab plus carboplatin/paclitaxel followed by avelumab maintenance.
Topline results showed no PFS benefit in either of the avelumab groups, prompting the decision to discontinue the trial.
Data are still being analyzed, and more detailed results will be released in the future.
The safety profile of avelumab appeared consistent with that observed in other studies. No new safety signals were reported.
The JAVELIN clinical development program is assessing avelumab for more than 15 tumor types, including ovarian cancer, breast cancer, head and neck cancer, gastric and gastroesophageal junction cancers, Merkel cell carcinoma, non-small cell lung cancer, renal cell carcinoma and urothelial carcinoma.