AstraZeneca and Merck have reported positive results from the Phase III SOLO-1 clinical trial designed to assess Lynparza (olaparib) as a maintenance therapy for women suffering from ovarian cancer.
The trial recruited 391 advanced BRCA-mutated (BRCAm) ovarian cancer patients who were in complete or partial response after undergoing first-line standard platinum-based chemotherapy.
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Data showed statistically significant and clinically meaningful improvement in progression-free survival (PFS) in Lynparza arm, compared to placebo. The risk of disease progression or death was found to have decreased by 70%.
Nearly 60% of participants treated with Lynparza sustained progression-free status at 36 months, compared to 27% of women in the placebo arm.
AstraZeneca chief medical officer and Global Medicines Development executive vice-president Sean Bohen said: “There is currently a significant unmet need in the treatment of advanced ovarian cancer because 70% of women relapse within the first three years after their initial treatment.
“The remarkable results of the SOLO-1 trial, which showed that 60% of women with newly diagnosed, advanced BRCA-mutated ovarian cancer remained progression-free at three years, highlight the potential of Lynparza as a maintenance therapy in the first-line setting.”
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By GlobalDataLynparza is a PARP inhibitor developed to potentially target DNA damage response (DDR) pathway deficiencies, including BRCA mutations, to kill cancer cells.
AstraZeneca and Merck formed a strategic oncology alliance in July last year to develop the drug for the treatment of various cancers.
SOLO-1 is a randomised, double-blinded, placebo-controlled, multi-centre trial to investigate the efficacy and safety of 300mg twice daily Lynparza tablets as monotherapy in ovarian cancer patients.
During the trial, the drug’s safety profile was found to be consistent with that observed in previous studies. The most common adverse events were nausea, fatigue, vomiting, anaemia and diarrhoea.
The drug currently holds approval in more than 60 countries for treating platinum-sensitive relapsed ovarian cancer, irrespective of BRCA status.
