Table 1.
Phase II/III studies of olaparib in ovarian cancer
| Study | Patient population and BRCA status | Treatment arms | Total accrual | Primary endpoint | ORR | PFS |
|---|---|---|---|---|---|---|
| Audeh et al,55 2010 | Recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma BRCA1/2 positive |
Cohort 1: olaparib 400 mg BID Cohort 2: olaparib 100 mg BID |
57 | ORR | Cohort 1: 33% Cohort 2: 13% |
Cohort 1: 5.8 months Cohort 2: 1.9 months |
| Kaye et al,56 2012 | Platinum-resistant, recurrent, epithelial ovarian, primary peritoneal, or fallopian tube carcinoma BRCA1/2 positive |
Arm 1: olaparib 200 mg BID Arm 2: olaparib 400 mg BID Arm 3: PLD 50 mg/m2 |
97 | PFS | Arm 1: 25% Arm 2: 31% Arm 3: 18% |
Arm 1: 6.5 months Arm 2: 8.8 months Arm 3: 7.1 months |
| Gelmon et al,57 2011 | Advanced metastatic or recurrent ovarian, primary peritoneal, or fallopian tube cancer (high-grade serous and/or undifferentiated) or breast cancer BRCA1/2 positive AND BRCA1/2 negative |
Olaparib 400 mg BID | 91 (65 with gynecologic cancer) | ORR | BRCA1/2 positive: 41% BRCA1/2 negative: 24% BRCA1/2 positive+platinum sensitive: 60% BRCA1/2 negative+platinum sensitive: 50% BRCA1/2 positive+platinum resistant: 33% BRCA1/2 negative+platinum resistant: 4% |
BRCA1/2 positive: 221 days BRCA1/2 negative: 192 days |
| Ledermann et al,53 2014 | Platinum-sensitive, recurrent, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube carcinoma BRCA1/2 positive AND BRCA1/2 negative |
(Maintenance therapy following platinum- based chemotherapy) Arm 1: olaparib 400 mg BID Arm 2: placebo |
265 | PFS | Arm 1: 8.4 months Arm 2: 4.8 months Olaparib+BRCA1/2 positive: 11.2 months Olaparib+BRCA1/2 negative: 5.6 months Placebo+BRCA1/2 positive: 4.3 months Placebo+BRCA1/2 negative: 5.5 months |
|
| Oza et al,58 2015 | Platinum-sensitive, recurrent, serous ovarian cancer BRCA1/2 positive AND BRCA1/2 negative |
Arm 1: Olaparib 200 mg BID+paclitaxel 175 mg/m2+carboplatin AUC 4×6 cycles followed by olaparib 400 mg BID maintenance Arm 2: Paclitaxel 175 mg/m2+carboplatin AUC 4×6 cycles |
162 | PFS | Arm 1: 64% Arm 2: 58% |
Arm 1: 12.2 months Arm 2: 9.6 months |
| Kaufman et al,50 2015 | Platinum-resistant, recurrent, ovarian, primary peritoneal, or fallopian tube cancer BRCA1/2 positive |
Olaparib 400 mg BID | 193 | ORR | 31% | 225 days |
Abbreviations: AUC, area under the curve; ORR, objective response rate; PFS, progression-free survival; PLD, pegylated lyposomal doxorubicin.