1 Avelumab in combination with and/or following chemotherapy vs chemotherapy in treatment-naive patients with ovarian cancer: biomarker analyses from the phase 3 JAVELIN Ovarian 100 trial

Abstract

Introduction In the JAVELIN Ovarian 100 trial (NCT02718417), avelumab (anti‐PD‐L1) in combination with chemotherapy or as maintenance did not improve progressionfree survival (PFS) vs chemotherapy followed by observation in treatment‐naive patients with epithelial ovarian cancer (EOC; hazard ratios [95% CI] were 1.14 [0.832, 1.565] and 1.43 [1.051, 1.946], respectively). The trial was terminated when prespecified futility boundaries were crossed at the interim analysis, and study treatment was subsequently discontinued. Here we report biomarker analyses. Methods Women with stage III‐IV EOC (post debulking/cytoreductive surgery or candidates for neoadjuvant chemotherapy) were randomized 1:1:1 to receive carboplatin/paclitaxel chemotherapy (6 cycles) followed by avelumab every 2 weeks as maintenance (CTx!Ave), chemotherapy + avelumab (10 mg/ kg every 3 weeks) followed by avelumab every 2 weeks as maintenance (CTx+Ave!Ave), or chemotherapy followed by observation (CTx!O; control arm). The primary endpoint was PFS by blinded independent central review per RECIST version 1.1. Pretreatment tumor tissue was analyzed by immunohistochemistry (CD8 and PD‐L1) and next‐generation DNA and RNA sequencing. Results 998 patients were randomized. Subgroup analyses based on PD‐L1, CD8, and germline BRCA1/2 status did not identify subsets with clear PFS benefit in either avelumab arm vs control (table 1). Whole‐exome and RNA sequencing analyses will be presented. Conclusions In the JAVELIN Ovarian 100 trial, PD‐L1, CD8, and germline BRCA1/2 status did not predict differential clinical benefit with the addition of avelumab to chemotherapy in treatment‐naive patients with EOC. (Table Presented).