What is the role of olaparib (Lynparza) in the treatment of ovarian cancer?

Updated: Aug 10, 2020
  • Author: Andrew E Green, MD; Chief Editor: Yukio Sonoda, MD  more...
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Olaparib is an inhibitor of PARP1, PARP2, and PARP3. Olaparib capsules and tablets are approved as monotherapy for deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer in patients who have been treated with three or more prior lines of chemotherapy. Additionally, the tablets are approved for maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. The tablets and capsules are not interchangeable on a mg-to-mg basis due to differences in the dosing and bioavailability of each formulation, and therefore, should not be substituted with one another.

Approval of olaparib tablets for maintenance therapy for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer was based on two randomized, placebo-controlled, double-blind, multicenter trials, SOLO-2 and Study 19. In the SOLO-2 clinical trial, 295 patients with recurrent germline BRCA-mutated ovarian, fallopian tube, or primary peritoneal cancer were randomly assigned to receive olaparib tablets 300 mg orally twice daily or placebo. A statistically significant improvement in progression-free survival (PFS) in the olaparib arm was observed that showed an improvement of 24.7 months (P < 0.0001) compared with placebo, thus reducing the risk for disease progression by nearly 75%. [103]

In the Study 19 (n=265) trial, patients were randomly assigned to receive olaparib capsules 400 mg orally twice daily or placebo. This cohort differed from that of the SOLO-2 trial in that patients did not have to harbor BRCA mutations. Results also showed a statistically significant improvement in investigator-assessed PFS in the olaparib arm as compared with placebo (P < 0.0001). The estimated median PFS was 8.4 months for the olaparib group and 4.8 months for the placebo group. [104]

Another phase II clinical trial involved 298 patients with ovarian cancer associated with germline BRCA1/2 mutations, all of whom received olaparib. The overall response rate was 31.1% and stabilization of disease > 8 weeks was seen in 40% of patients. [105]

Olaparib 400 mg PO BID continuously was compared with pegylated liposomal doxorubicin (PLD) 50 mg/m2 IV every 4 weeks. Median PFS was 8.8 months for olaparib compared with 7.1 months for PLD. Overall response rate was 31% for olaparib and 18% for PLD. [106]

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