Frontline olaparib significantly improved PFS compared with placebo among women with BRCA-mutated advanced ovarian cancer, according to interim results from the SOLO-1 trial.
Olaparib (Lynparza; AstraZeneca, Merck) — a first-in-class PARP inhibitor — is approved for the treatment of women with deleterious or suspected deleterious germline BRCA–mutated advanced ovarian cancer who received three or more prior lines of chemotherapy.
In the phase 3, double-blind SOLO-1 trial, researchers assessed the safety and efficacy of olaparib in the first-line maintenance setting among 391 women with BRCA-mutated advanced ovarian cancer who achieved clinical complete or partial response after platinum-based chemotherapy. Investigators randomly assigned patients 2:1 to olaparib 300 mg or placebo twice daily.
“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, said in a company-issued press release. “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.”
The safety and tolerability of olaparib appeared consistent with previous trials of the drug.
“We look forward to presenting the full data set for SOLO-1 at a future medical meeting and working with regulatory authorities to bring Lynparza to women with ovarian cancer in the first-line maintenance setting as quickly as possible,” Roy Baynes, senior vice president, head of global clinical development and chief medical officer at MSD Research Laboratories, said in the release.