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

Trial ID # NCT00483782; ICON7
Phase III
Drug Class Angiogenesis Inhibitors: VEGF
Drug Name Bevacizumab
Alternate Drug Names immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin
Drugs in Trial Bevacizumab, Carboplatin, Paclitaxel
Eligible Participant

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

Patients Enrolled

1,528

Therapy Setting

First-line, Maintenance

Study Design

Open-Label, Randomized

Endpoints

PFS, OS, evaluated per RECIST

Efficacy

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:
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)

Clinically Significant Adverse Events

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%)

Conclusion

PFS and OS advantage only in high risk patients

Reference

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