(n = 764)
 CPB7.5+

(n = 764)
 
Median (months)
 58.0
 57.4
 
Hazard ratio [95% CI]
 0.99 [0. 85; 1. 15]

(p-value = 0. 8910)
 

1 In patients with measurable disease at baseline.

2 Investigator assessed PFS analysis with data cut-off date of 30 November 2010.

3 Final overall survival analysis performed when 46.7% of the patients had died with data cut-off date of 31 March 2013.

The primary analysis of investigator-assessed PFS with a data cut-off date of 28 February 2010 shows an unstratified hazard ratio of 0.79 (95% CI: 0.68-0.91, 2-sided log-rank p-value 0.0010) with a median PFS of 16.0 months in the CP arm and 18.3 months in the CPB7.5+ arm.

PFS subgroup analyses by disease stage and debulking status are summarised in Table 18. These results demonstrate robustness of the primary analysis of PFS as shown in Table 17.

Table 18 PFS1 results by disease stage and debulking status from study BO17707 (ICON7)

Randomised patients stage III optimally debulked disease 2,3
 
  CP

(n = 368)
 CPB7.5+

(n = 383)
 
Median PFS (months)
 17.7
 19.3
 
Hazard ratio (95% CI) 4
    0.89

(0.74, 1.07)
 
Randomised patients with stage III suboptimally debulked disease3
 
  CP

(n = 154)
 CPB7.5+

(n = 140)
 
Median PFS (months)
 10.1
 16.9
 
Hazard ratio (95% CI)4
    0.67

(0.52, 0.87)
 
Randomised patients with stage IV disease
 
  CP

(n = 97)
 CPB7.5+

(n = 104)
 
Median PFS (months)
 10.1
 13.5
 
Hazard Ratio (95% CI)4
    0.74

(0.55, 1.01)
 

1 Investigator assessed PFS analysis with data cut-off date of 30 November 2010.

2 With or without gross residual disease.

3 5.8% of the overall randomised patient population had Stage IIIB disease.

4 Relative to the control arm.

Recurrent ovarian cancer

The safety and efficacy of Avastin in the treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer was studied in two phase III trials (AVF4095g and MO22224) with different patient populations and chemotherapy regimens.

• AVF4095g eva luated the efficacy and safety of bevacizumab in combination with carboplatin and gemcitabine in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.

• MO22224 eva luated the efficacy and safety of bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.

AVF4095g

The safety and efficacy of Avastin in the treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who have not received prior chemotherapy in the recurrent setting or prior bevacizumab treatment, was studied in a phase III randomised, double-blind, placebo-controlled trial (AVF4095g). The study compared the effect of adding Avastin to carboplatin and gemcitabine chemotherapy and continuing Avastin as a single ag