(0.49, 0.82)
 

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 With gross residual disease.

3 3.7% of the overall randomised patient population had Stage IIIB disease.

4 Relative to the control arm.

BO17707 (ICON7)

BO17707 was a Phase III, two arm, multicentre, randomised, controlled, open-label study comparing the effect of adding Avastin to carboplatin plus paclitaxel in patients with FIGO stage I or IIA (Grade 3 or clear cell histology only; n = 142), or FIGO stage IIB - IV (all Grades and all histological types, n = 1386) epithelial ovarian, fallopian tube or primary peritoneal cancer following surgery (NCI-CTCAE v.3).

Patients who had received prior therapy with bevacizumab or prior systemic anticancer therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitor therapy, or hormonal therapy) or previous radiotherapy to the abdomen or pelvis were excluded from the study.

A total of 1528 patients were randomised in equal proportions to the following two arms:

• CP arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks duration

• CPB7.5+ arm: Carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles of 3 weeks plus Avastin (7.5 mg/kg q3w) for up to 12 months (Avastin was started at cycle 2 of chemotherapy if treatment was initiated within 4 weeks of surgery or at cycle 1 if treatment was initiated more than 4 weeks after surgery).

The majority of patients included in the study were White (96%), the median age was 57 years in both treatment arms, 25% of patients in each treatment arm were 65 years of age or over, and approximately 50% of patients had an ECOG PS of 1; 7% of patients in each treatment arm had an ECOG PS of 2. The majority of patients had EOC (87.7%) followed by PPC (6.9%) and FTC (3.7%) or a mixture of the three origins (1.7%). Most patients were FIGO Stage III (both 68%) followed by FIGO Stage IV (13% and 14%), FIGO Stage II (10% and 11%) and FIGO Stage I (9% and 7%). The majority of the patients in each treatment arm (74% and 71%) had poorly differentiated (Grade 3) primary tumours at baseline. The incidence of each histologic sub-type of EOC was similar between the treatment arms; 69% of patients in each treatment arm had serous adenocarcinoma histologic type.

The primary endpoint was PFS as assessed by the investigator using RECIST.

The trial met its primary objective of PFS improvement. Compared to patients treated with chemotherapy (carboplatin and paclitaxel) alone in the front-line setting, patients who received bevacizumab at a dose of 7.5 mg/kg q3w in combination with chemotherapy and continued to receive bevacizumab for up to 18 cycles had a statistically significant improvement in PFS.

The results of this study are summarised in Table 17.

Table 17 Efficacy results from study BO17707 (ICON7)

Progression-free survival
 
  CP

(n = 764)
 CPB7.5+

(n =764)
 
Median PFS (months) 2
  16.9
  19.3
 
Hazard ratio [95% CI] 2
 0.86 [0.75; 0.98]

(p-value = 0.0185)
 
Objective Response Rate 1
 
  CP

(n = 277)
 CPB7.5+

(n = 272)
 
Response rate
 54.9%
 64.7%
 
  (p-