Wen Yee Chay

Durvalumab versus Physician’s Choice Chemotherapy in Recurrent Ovarian Clear Cell Adenocarcinoma (MOCCA/APGOT-OV2/GCGS-OV3): A Multicenter, Randomized, Phase 2 Trial

Abstract Purpose: 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. Patients and Methods: 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. Results: 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]. Conclusions: Durvalumab was well-tolerated but did not improve efficacy outcomes compared with chemotherapy in rOCCC.

Pan-Asia adapted ESMO Clinical Practice Guideline for the management of patients with newly diagnosed and relapsed epithelial ovarian cancer

The European Society for Medical Oncology (ESMO) Clinical Practice Guideline for the diagnosis, treatment and follow-up of patients with newly diagnosed and relapsed epithelial ovarian cancer (EOC), published in 2023, was adapted in July 2024, according to established standard methodology, to produce the Pan-Asian adapted ESMO consensus guideline for the management of Asian patients with EOC. The adapted guideline presented in this manuscript represents the consensus opinions reached by a panel of Asian experts in the treatment of patients with EOC representing the oncological societies of China, Indonesia, India, Japan, Korea, Malaysia, the Philippines, Singapore, Taiwan and Thailand, coordinated by ESMO and the Indian Society of Medical and Pediatric Oncology. Voting was based on scientific evidence and was independent of current treatment practices, drug access restrictions and reimbursement decisions in the represented countries. Drug access and reimbursement across Asia are discussed separately in the manuscript. The Pan-Asian consensus aims to guide the optimisation and harmonisation of management of patients with EOC in Asia, drawing on the evidence provided by both Western and Asian trials. Attention is drawn to the disparity in the drug approvals and reimbursement strategies between countries.