Lynparza Lengthens Survival in Women with Ovarian Cancer

Women who took Lynparza (olaparib; AstraZeneca) tablets as a monotherapy for maintenance treatment of platinum-sensitive relapsed BRCA-mutated ovarian cancer showed significantly improved progression-free survival compared with women who took placebo, according to a recent press release.

Furthermore, the median progression-free survival among women who took Lynparza tablets in the phase 3 SOLO-2 trial substantially exceeded what had been demonstrated in a previous phase 2 maintenance study, according to the company.

“We are pleased with the robust improvement in progression-free survival demonstrated by Lynparza in the SOLO-2 trial. We will work with regulatory authorities to make Lynparza tablets available as quickly as possible to patients with ovarian cancer,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a press release. “We remain committed to investigating the full potential of Lynparza, both as monotherapy and in combinations, and to identifying all patients who may benefit from this important medicine.”

Full results of the trial have not yet been released but will be presented at an upcoming medical meeting, a company press release stated. AstraZeneca did reveal that SOLO-2 involved 295 women with platinum-sensitive relapsed BRCA-mutated ovarian cancer who had been treated with at least 2 prior lines of platinum-based chemotherapy. The women were randomized to receive 300 mg of Lynparza twice a day or placebo until disease progression. 

In addition to demonstrating improvements in progression-free survival compared with placebo as well as Lynparza performance in an earlier study, Lynparza tablets demonstrated a safety profile in SOLO-2 that was consistent with previous trials, AstraZeneca reported.

Lynparza capsules (400 mg twice daily) are approved by the US Food and Drug Administration (FDA) as monotherapy for patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have received 3 or more prior lines of chemotherapy. The capsules were cleared under accelerated FDA approval based on response rate and duration. Continued approval may be dependent upon verification of clinical benefit in confirmatory trials. 

Lynparza tablets are an investigational formulation and are not approved for any use by the FDA.

Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that is thought to exploit tumor DNA damage response pathway deficiencies to kill cancer cells.—Jolynn Tumolo