ICON9: A phase 3 randomised trial of cediranib and olaparib maintenance in patients with relapsed platinum sensitive ovarian cancer

Project Member(s): Viney, R., Vargas Parada, C.

Funding or Partner Organisation: National Health & Medical Research Council (NHMRC- Clinical Trials and Cohort Studies Grants)
National Health & Medical Research Council (NHMRC- Clinical Trials and Cohort Studies Grants)

Start year: 2022

Summary: In Australia, ovarian cancer is the most common cause of gynaecological cancer death and it is the sixth most common cause of cancer death in women. Despite optimal primary treatment with surgery and platinum-based chemotherapy, 80% of women develop cancer recurrence that is ultimately fatal. Cediranib (targeting angiogenesis) and olaparib (targeting DNA repair) have individually shown anti-tumour activity in recurrent ovarian cancer with a survival benefit. Combining these drugs has demonstrated greater activity than either drug alone, particularly in women without BRCA1 or BRCA2 mutations, who make up the majority of women with recurrent ovarian cancer. ICON-9 is an international investigator-initiated, randomised, phase 3 trial investigating the combination of cediranib and olaparib compared to olaparib alone as maintenance therapy following response to second-line chemotherapy in women with recurrent ovarian cancer. Eligible patients are randomised in a 1:1 ratio, and continue treatment until disease progression. ICON-9 represents a major global research effort led by Cancer Research UK with Australian CIs leading sub-studies in quality of life and health economic assessment, as well as recruitment in Australia and New Zealand (ANZ). In ANZ, the study is led by ANZ Gynaecological Oncology Group and NHMRC Clinical Trials Centre. Funded by Cancer Australia grant (APP1100619), ICON-9 is on track to complete accrual of 110 ANZ participants from 19 ANZ sites, which represents one third of the total patients required internationally (330). This application seeks funding over 3 years to complete planned follow-up for all 110 ANZ participants for analysis of the primary survival outcome (progression free survival). Secondary outcome measures include overall survival, toxicity, quality of life, and cost effectiveness. Global accrual is expected to complete in 2024 with presentation of results in 2025.

FOR Codes: Health economics , Evaluation of health outcomes

Acknowledgement of Country

UTS acknowledges the Gadigal people of the Eora Nation, the Boorooberongal people of the Dharug Nation, the Bidiagal people and the Gamaygal people, upon whose ancestral lands our university stands. We would also like to pay respect to the Elders both past and present, acknowledging them as the traditional custodians of knowledge for these lands.