- The Food and Drug Administration has approved AstraZeneca and Merck & Co.'s Lynparza for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer, the first for a PARP inhibitor in this indication.
- Approval was based on results from the pivotal Phase 3 SOLO-1 trial, where Lynparza cut the risk of disease progression or death by 70% in patients with BRCA-mutated advanced ovarian cancer who had a complete or partial response to platinum-based chemotherapy.
- Fresh data released Dec. 20 offered further support of Lynparza's clinical profile in later lines of treatment, too. Lynparza improved response rates over chemotherapy in patients with relapsed, BRCA-mutated ovarian cancer who had failed two or more previous treatments, according to the topline results. The two pharmas plan to discuss these latest data with the FDA.
Clinical results like those from SOLO-1, and now from SOLO-3, should serve to bolster AstraZeneca and Merck's edge in the market for PARP inhibitors, which includes rival treatments from Tesaro and Clovis Oncology.
Lynparza (olaparib) already held approvals in advanced ovarian and breast cancer, and has been used in over 20,000 patients globally.
Expanded approval as a first-line maintenance therapy could broaden its potential market. SOLO-1 data showed Lynparza increased the changes for long-term remission in women who respond to initial chemotherapy. Three-fifths of those treated with AstraZeneca and Merck's drug remained progression-free at the years, compared with only 27% of those given placebo.
The SOLO-3 results announced this week in relapsed ovarian cancer after multiple lines of chemotherapy, are the fourth positive Phase 3 data for the drug, according to the company, and the first positive Phase 3 trial against chemotherapy for a PARP inhibitor in advanced ovarian cancer.
Lynparza is also in other trials in advanced ovarian cancer, including the Phase 3 trial, PAOLA-1, testing it in combination with Avastin (bevacizumab) as a maintenance treatment for patients with newly-diagnosed advanced ovarian cancer, regardless of their BRCA status.
The study should read out in the second half of 2019. AstraZeneca and Merck are also pushing ahead with other indications for Lynparza, including a Phase 3 trial, PROfound, in prostate cancer.