AstraZeneca has unveiled data from a late-stage trial showing that Lynparza improved progression free survival (PFS) in patients with a certain form of ovarian cancer when used in the maintenance setting.
The Phase III SOLO-2 study met its primary goal of a significant improvement in investigator determined PFS in patients germline BRCA-mutated (gBRCA), platinum-sensitive, relapsed ovarian cancer patients treated with Lynparza (olaparib) versus placebo (median 19.1 months vs 5.5 months).
Also, PFS as measured by Blinded Independent Central Review (BICR) evaluation - a pre-specified analysis supporting the primary endpoint - demonstrated a median PFS of 30.2 months vs 5.5 months for placebo, representing an improvement of 24.7 months, the firm noted.
Key secondary endpoints - including a statistically-significant benefit in time to second progression or death (PFS2) - were also met, providing further evidence in support of the drug’s use in the maintenance setting in relapsed ovarian cancer.
The results, which were presented at the Society of Gynaecologic Oncology Annual Meeting on Women’s Cancer in National Harbor, US, are “very encouraging”, said Eric Pujade-Lauraine, head of the Women Cancers and Clinical Research Department at Hôpitaux Universitaires Paris Centre, site Hôtel-Dieu, AP-HP and principal investigator of SOLO-2.
“They build upon previous trials examining Lynparza in platinum-sensitive relapsed BRCA-mutated ovarian cancer,” and “most importantly, patients were able to maintain quality of life while experiencing an impressive delay in disease progression.”
“We are extremely pleased with the results from SOLO2, which support the potential benefit of Lynparza tablets as a maintenance therapy for patients with relapsed ovarian cancer,” added Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AZ.”
“The tablet formulation may offer patients a reduced pill burden for Lynparza and a safety profile that is generally consistent with previous trials. We will work with regulatory authorities to make Lynparza tablets available to patients as quickly as possible.”
Ovarian cancer is a serious and life-threatening condition causing more than 4,000 deaths in the UK each year. Up to 21 percent with the most aggressive form of ovarian cancer have the genetic BRCA mutation.
The drug, a first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells, is already approved in the EU and US for the treatment of women with BRCAm ovarian cancer.