by Dr. C.H. Weaver M.D. updated 6/2019
In the initial phase II clinical trial, Lynparza (olaparib) delayed cancer progression—but did not improve overall survival—when given after chemotherapy to women with relapsed, platinum-sensitive, serous ovarian cancer. These results were initially published in the New England Journal of Medicine.
In a second trial - the SOLO3 clinical trial which was updated at the 2019 American Society of Clinical Oncology annual meeting, Lynparza delayed the time to cancer progression compared with non-platinum chemotherapy in women with germline BRCA-mutated, platinum-sensitive relapsed ovarian cancer.
About Lynparza (olaparib)
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of selected patients with ovarian, fallopian tube, or primary peritoneal cancer. The PARP enzyme plays a role in DNA repair, including the repair of DNA damage from chemotherapy. Precision cancer medicines that target and inhibit this enzyme may contribute to cancer cell death and increased sensitivity to chemotherapy and are called PARP inhibitors. By blocking this enzyme, DNA inside the cancerous cells is less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth.
In the SOLO-3 clinical trial 200 women with BRCA-mutated, platinum-sensitive relapsed ovarian cancer were treated with Lynparza (n = 178) or the physician’s choice of chemotherapy (n = 88) until evidence of cancer progression. Physician choice included paclitaxel (n = 20), topotecan (n = 8), gemcitabine (n = 13) or pegylated liposomal doxorubicin (n = 47). The study was designed to measure the response to treatment and time until cancer progression.
Overall Lynparza treatment was well tolerated and 72% of Lynparza treated patients responded to treatment compared to 51% of those receiving chemotherapy. The time until cancer progression was 13.4 months with Lynparza compared to 9.2 months with chemotherapy.
To assess the safety and efficacy of Lynparza in ovarian cancer, researchers initially conducted a phase II clinical trial of 265 women with relapsed, platinum-sensitive, serous ovarian cancer. After treatment with chemotherapy, women were assigned to further treatment (maintenance therapy) with either olaparib or a placebo.
- Women in the Lynparza group remained free of cancer progression longer than women in the placebo group: median progression-free survival was 8.4 months in the Lynparza group and 4.8 months in the placebo group.
The results of this study suggest that Lynparz is active against relapsed, platinum-sensitive, serous ovarian cancer and can delay cancer progression, but still has not been shown to improve overall survival. Results based on longer follow-up will provide better information about whether Lynparza affects overall survival.
- Ledermann J, Harter P, Gourley C et al. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. New England Journal of Medicine. Early online publication March 27, 2012.
- Penson RT, et al. Abstract 5506. Presented at: ASCO Annual Meeting; May 31-June 4, 2019; Chicago.
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