Olaparib Delays Disease Progression as First-Line Treatment in Advanced Ovarian Cancer

Olaparib (Lynparza, Merck and AstraZeneca) improved progression-free survival (PFS) as a first-line treatment in women with BRCA-mutated (BRCAm) advanced ovarian cancer in a phase 3 trial, according to a press release.

The SOLO-1 phase 3 trial evaluated the efficacy and safety of olaparib tablets as a first-line maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer. The trial included 391 patients with a deleterious or suspected deleterious BRCA1 or BRCA2 mutation who were in clinical complete or partial response following platinum-based chemotherapy.

The primary endpoint of the trial was PFS and key secondary endpoints included time to second disease progression or death and overall survival.

In the study, women were either treated with olaparib 300-mg tablets twice daily or placebo tablets twice daily. Those who received olaparib had a statistically significant and clinically meaningful improvement in PFS compared with a placebo. Olaparib also demonstrated a consistent safety and tolerability profile.

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“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, global medicines development and chief medical officer at AstraZeneca, said in a 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.”

Olaparib is not currently approved for first-line maintenance treatment of ovarian cancer. It is indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCAm advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy.

In addition to SOLO-1, the ongoing GINECO/ENGOTov25 phase 3 trial, PAOLA-1, is testing the effect of olaparib in combination with bevacizumab as a first-line maintenance treatment in women with newly diagnosed advanced ovarian cancer, regardless of their BRCA status.

Reference

Lynparza (olaparib) significantly delays disease progression in phase 3 first-line SOLO-1 trial for ovarian cancer [news release]. Merck’s website. http://www.mrknewsroom.com/news-release/oncology/lynparza-olaparib-significantly-delays-disease-progression-phase-3-first-line-. Accessed June 28, 2018.