ICON7 - A Randomised, Two-Arm, Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy (Carboplatin and Paclitaxel) in Patients With Epithelial Ovarian Cancer

Newly Diagnosed Stage I-IIA (Grade 3 or clear cell) or Stage IIB-IV after primary surgery

1,528

First-line, Maintenance

Open-Label, Randomized

PFS, OS, evaluated per RECIST

Exploratory: High Risk: Stage IV disease or with suboptimal debulking surgery; CA125 KELIM score

CarboPt+Pac+Bev w/ Bev maint vs CarboPt+Pac:

All:
PFS: 19.9 vs 17.5 months, HR: 0.93 (0.83-1.05, p=0.25)
OS: 45.5 vs 44.6 months (p=0.85, restricted mean survival)

Exploratory analysis in high risk patients; CA125 KELIM score:
CarboPt+Pac+Bev w/ Bev maint vs CarboPt+Pac:
high risk:PFS: 16.0 vs 10.5 months, HR: 0.73 (0.61-0.88, p= 0.001); OS: 39.3 vs 34.5 months (p=0.03, restricted mean survival)
high risk KEL unfav: OS: 29.7 vs 20.6 months, HR: 0.78 (0.58-1.04)
high risk KEL fav: OS: 48.2 vs 46.6 months, HR: 0.93 (0.65-1.34)
low risk KEL unfav: OS: 52.8 vs 49.8 months, HR: 1.05 (0.78-1.42)
low risk KEL fav: OS: 65.0 vs 62.8 months, HR: 1.18 (0.87-1.58)

CarboPt+Pac+Bev w/ Bev maint vs CarboPt+Pac:
Serious AE: GI perforation (1% vs <1%), CNS bleeding (<1% vs 0)
Grade 3-4 AE: hypertension (6% vs <1%)

PFS and OS advantage only in high risk patients

Perren TJ et al. A Phase 3 Trial of Bevacizumab in Ovarian Cancer. NEJM (2011) 365:2484-96.
http://www.ncbi.nlm.nih.gov/pubmed/22204725

Oza AM et al. Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial. Lancet Oncol (2015) 16(8):928-36
http://www.ncbi.nlm.nih.gov/pubmed/26115797

You B et al. Bevacizumab for Newly Diagnosed Ovarian Cancers: Best Candidates Among High-Risk Disease Patients (ICON-7). JCNI Cancer Spektr (2020) 4(3):pkaa026
https://pubmed.ncbi.nlm.nih.gov/32596636/