Positive results have been reported from a phase 3 study designed to determine the efficacy of olaparib (Lynparza, AstraZeneca) as monotherapy for the maintenance treatment of women with platinum-sensitive, relapsed, BRCA-mutated ovarian cancer. The results demonstrated a statistically significant improvement in progression-free survival (PFS) among patients treated with olaparib compared with those given placebo.
The positive findings follow the fast-track designation assigned to olaparib by the FDA earlier this year for patients with a BRCA mutation who have platinum-sensitive, relapsed ovarian cancer.
Olaparib is a first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that is believed to exploit deficiencies in the tumor DNA damage response (DDR) pathway to preferentially kill cancer cells. It is approved by the FDA for the treatment of women with BRCA-mutated ovarian cancer.
Patients with either germline or somatic BRCA mutation status were eligible for enrollment in the SOLO-2 trial, although, because of the limited availability of tumor BRCA testing, most patients were enrolled on the basis of blood-based germline testing. The few patients who were enrolled based on a tumor test were also found to have a germline BRCA mutation. The patients were randomly assigned to receive either olaparib tablets (300 mg twice daily) or placebo until disease progression occurred. The trial included 295 patients with documented germline BRCA1 or BRCA2 mutations who had received at least two prior lines of platinum-based chemotherapy.
The median PFS in the olaparib arm substantially exceeded that observed in a phase 2 maintenance study in patients with platinum-sensitive relapsed ovarian cancer.
Source: AstraZeneca; October 26, 2016.