Maintenance therapy with single-agent olaparib significantly improved progression-free survival (PFS) compared with placebo among patients with platinum-sensitive relapsed, BRCA-mutated ovarian cancer, according to an announcement by AstraZeneca, the developer of olaparib.1
Results of the phase 3 SOLO-2 trial (ClinicalTrials.gov Identifier: NCT01874353) showed that median PFS with olaparib substantially exceeded that observed in the phase 2 maintenance study among patients with platinum-sensitive relapsed ovarian cancer.
“We are pleased with the robust improvement in progression-free survival demonstrated by Lynparza in the SOLO-2 trial,” Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said in a press release. “We will work with regulatory authorities to make Lynparza tablets available as quickly as possible to patients with ovarian cancer.”
The safety profile of olaparib was consistent with previous reports. No new safety signals were observed.
To assess the efficacy of olaparib tablets as maintenance monotherapy compared with placebo, investigators enrolled 295 patients with either germline or somatic BRCA-mutated relapsed or recurrent ovarian cancer who were sensitive to platinum-therapy. Participants had received at least 2 prior lines of platinum-based chemotherapy.
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Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor approved as monotherapy for patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy.
- Lynparza phase III SOLO-2 trial shows significant progression-free survival benefit. AstraZeneca website. https://www.astrazeneca.com/media-centre/press-releases/2016/lynparza-phase-iii-solo-2-trial-shows-significant-progression-free-survival-benefit-261020161.html. Updated October 26, 2016. Accessed October 28, 2016.