Durvalumab versus Physician's Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinoma...

The optimal treatment of recurrent ovarian clear cell carcinoma (rOCCC) remains unknown. This is the first randomized trial to compare durvalumab with chemotherapy in rOCCC.

MOCCA is a randomized, phase 2 trial conducted in Singapore, Korea, and Australia. Eligible patients had rOCCC with recurrence after platinum-based chemotherapy, Eastern Cooperative Oncology Group performance status ≤2, and no prior immune checkpoint blockade. Patients were randomly assigned (2:1) to durvalumab (1,500 mg every 4 weeks) or chemotherapy. Patients progressing on chemotherapy were allowed to cross over to durvalumab. The primary outcome was progression-free survival. Secondary outcomes included overall survival, objective response rates, and safety.

Forty-eight eligible women were assigned to durvalumab (N = 31) or chemotherapy (N = 17). The median progression-free survival was 7.6 [95% confidence interval (CI), 7.0-16.0] and 14.0 (95% CI, 7.0-32.9) weeks with durvalumab and chemotherapy, respectively (HR = 1.6; 95% CI, 0.8-3.0; P = 0.92). The median overall survival was 37.9 (95% CI, 21.7-143.0) and 40.6 (95% CI, 25.0-not reached) weeks, respectively (HR = 1.5; 95% CI, 0.7-3.3; P = 0.85). The difference in objective response rates between the groups was not statistically significant (durvalumab 9.7% vs. physician's choice chemotherapy 18.8%; difference -9.1%; 95% CI, -31.3% to 12.9%; P = 0.83). Fewer all-grade (35.5% vs. 68.8%) and high-grade (9.7% vs. 31.3%) treatment-related adverse events were observed for durvalumab. PD-L1 combined positive score (CPS)+ was observed in 28.9% (CPS ≥1%) and 10.5% (CPS ≥10%) of patients. PIK3CA mutations were associated with time to progression on durvalumab ≥12 weeks [relative risk (mutated vs. wild-type) 2.83; 95% CI, 1.16-14.17].

Durvalumab was well-tolerated but did not improve efficacy outcomes compared with chemotherapy in rOCCC.