(n = 403)
 
% pts with objective response
 63.4
 66.2
 66.0
 
p-value
   0.2341
 0.2041
 
Overall survival 6
 
  CPP

(n = 625)
 CPB15

(n = 625)
 CPB15 +

(n = 623)
 
Median OS (months)
 40.6
 38.8
 43.8
 
Hazard Ratio (95% CI) 2
    1.07 (0.91, 1.25)
  0.88 (0.75, 1.04)
 
p-value 3
    0.2197
  0.0641
 

1 Investigator assessed GOG protocol-specified PFS analysis (neither censored for CA-125 progressions nor censored for NPT prior to disease progression) with data cut-off date of 25 February, 2010.

2 Relative to the control arm; stratified hazard ratio.

3 One-sided log-rank p-value

4 Subject to a p-value boundary of 0.0116.

5 Patients with measurable disease at baseline.

6 Final overall survival analysis performed when 46.9% of the patients had died.

Prespecified PFS analyses were conducted, all with a cut-off date of 29 September 2009. The results of these prespecified analyses are as follows:

• The protocol specified analysis of investigator-assessed PFS (without censoring for CA-125 progression or non-protocol therapy [NPT]) shows a stratified hazard ratio of 0.71 (95% CI: 0.61-0.83, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 10.4 months in the CPP arm and 14.1 months in the CPB15+ arm.

• The primary analysis of investigator-assessed PFS (censoring for CA-125 progressions and NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.52-0.75, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 12.0 months in the CPP arm and 18.2 months in the CPB15+ arm.

• The analysis of PFS as determined by the independent review committee (censoring for NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.50-0.77, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 13.1 in the CPP arm and 19.1 months in the CPB15+ arm.

PFS subgroup analyses by disease stage and debulking status are summarised in Table 16. These results demonstrate robustness of the analysis of PFS as shown in Table 15.

Table 16 PFS1 results by disease stage and debulking status from study GOG-0218

Randomised patients stage III optimally debulked disease 2,3
 
  CPP

(n = 219)
 CPB15

(n = 204)
 CPB15+

(n = 216)
 
Median PFS (months)
 12.4
 14.3
 17.5
 
Hazard ratio (95% CI)4
    0.81

(0.62, 1.05)
  0.66

(0.50, 0.86)
 
Randomised patients with stage III suboptimally debulked disease3
 
  CPP

(n = 253)
 CPB15

(n = 256)
 CPB15+

(n = 242)
 
Median PFS (months)
 10.1
 10.9
 13.9
 
Hazard ratio (95% CI)4
    0.93

(0.77, 1.14)
  0.78

(0.63, 0.96)
 
Randomised patients with stage IV disease
 
  CPP

(n = 153)
 CPB15

(n = 165)
 CPB15+

(n = 165)
 
Median PFS (months)
 9.5
 10.4
 12.8
 
Hazard Ratio (95% CI)4
    0.90

(0.70, 1