Avelumab in platinum-resistant/refractory ovarian cancer (PRROC): phase 3 results from JAVELIN Ovarian 200

Abstract

Abstract Background JAVELIN Ovarian 200 (NCT02580058), a randomized, open-label, phase 3 trial, investigated avelumab (Ave; anti-PD-L1) alone or Ave + pegylated liposomal doxorubicin (PLD) vs PLD alone in patients (pts) with PRROC. In the overall population (N = 566), Ave did not improve progression-free survival (PFS) or overall survival (OS) vs PLD, and PFS and OS prolongation with Ave+PLD vs PLD did not reach prespecified significance thresholds. We report data from Japanese pts. Methods Women with PRROC, ≤3 prior lines for platinum-sensitive disease, and no prior therapy for platinum-resistant disease were randomized 1:1:1 to Ave (10 mg/kg Q2W), Ave+PLD (40 mg/m2 Q4W), or PLD. Pts were stratified by platinum status (refractory vs resistant), prior regimens (1 vs 2 or 3), and bulky disease (tumor ≥5 vs Results 52 Japanese pts received Ave (n = 14), Ave+PLD (n = 18), or PLD (n = 20), including 34.6% with platinum-refractory disease, 53.8% with only 1 prior regimen, and 30.8% with bulky disease. Minimum follow-up was 16 mo (data cutoff Sep 19, 2018). Median PFS (95% CI) was 1.8 mo (1.3; 3.7) for Ave, 3.4 mo (1.9; 8.8) for Ave+PLD, and 1.9 mo (1.7; 7.4) for PLD (hazard ratios [HRs]: Ave vs PLD, 1.69 [95% CI 0.584; 4.897]; Ave+PLD vs PLD, 0.61 [0.229; 1.618]). Median OS (95% CI) was 21.2 mo (9.6; not estimable [NE]) for Ave, 13.4 mo (6.9; 20.7) for Ave+PLD, and 10.4 mo (5.0; NE) for PLD (HRs: Ave vs PLD, 0.57 [0.169; 1.950]; Ave+PLD vs PLD, 1.64 [0.614; 4.396]). Objective response rates (95% CI) were 14.3% (1.8; 42.8) for Ave, 5.6% (0.1; 27.3) for Ave+PLD, and 0% (0; 16.8) for PLD. No new safety signals were observed for Ave alone or Ave+PLD. Conclusion In this subgroup analysis, Ave and Ave+PLD showed potential clinical activity in Japanese pts with PRROC, with different trends for PFS and OS vs PLD, but the trial did not meet its primary endpoints in the overall population.