Lynparza Prolongs Disease Progression in Advanced Ovarian Cancer
PARP inhibitors continue to impress in the ovarian cancer space, as findings from the recent phase 3 SOLO-1 trial showed that Lynparza (olaparib) showed clinically-meaningful improvement in progression-free survival (PFS) when used in the first-line maintenance setting.
The ongoing, randomized, double-blind, multicenter trial compared Lynparza versus placebo in 392 women who had BRCA-mutant advanced (stage 3 or 4) ovarian cancer with deleterious or suspected deleterious BRCA1 or BRCA2 mutations. Patients received either 300-mg Lynparza tablets or placebo to take orally twice a day.
PFS served as the primary endpoint, with overall survival (OS) and time to second disease progression or death being secondary endpoints.
“For the first time, we see a significant and clinically-impactful improvement in progression-free survival in the first-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor,” Sean Bohen, executive vice president of Global Medicines Development and chief medical officer at AstraZeneca, the manufacturer of the drug, said in a statement.
Safety and tolerability of Lynparza was similar in the SOLO-1 trial as it was in previous studies investigating the drug.
According to the FDA, the most commonly observed side effects for Lynparza include anemia, nausea, fatigue (including asthenia), vomiting, nasopharyngitis, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation and stomatitis.
“The SOLO-1 data reinforce the importance of knowing BRCA status at diagnosis, as this may enable women with BRCA-mutated ovarian cancer to receive Lynparza earlier. We would like to thank the investigators, hospitals and most of all the patients who took part in this trial, without whom medical advancements would not be possible,” Bohen said.
Lynparza, the first of three approved PARP inhibitors to treat ovarian cancer, Lynparza (olaparib) was the first targeted treatment to potentially exploit DNA damage response pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells.
Lynparza is currently approved to treat women with advanced ovarian cancer and a germline BRCA mutation who have gone through at least three or more lines of chemotherapy. In the maintenance setting, it is approved to treat women (regardless of BRCA status) with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Moving forward, the ongoing GINECO/ENGOTov25 phase 3 PAOLA-1trial – for which results are expected in 2019 – is testing the efficacy of Lynparza in combination with Avastin (bevacizumab) as a first-line maintenance therapy for women with newly-diagnosed advanced ovarian cancer, regardless of their BRCA status.