Policy & Regulation
Lynparza Phase III Paola-1 Trial Met Primary Endpoint as 1st-line Maintenance Treatment with Bevacizumab for Advanced Ovarian Cancer
16 August 2019 - - UK-based pharmaceutical comapny AstraZeneca and US-based Merck and Co., Inc (NYSE: MRK) have received positive results from the Phase III PAOLA-1 trial in women with advanced ovarian cancer, the companies said.

The trial, in the 1st-line maintenance setting, compared Lynparza (olaparib) added to standard-of-care bevacizumab vs. bevacizumab alone in women with or without BRCA gene mutations.

The trial met its primary endpoint in the intent-to-treat population with a statistically-significant and clinically-meaningful improvement in progression-free survival, increasing the time women taking Lynparza plus bevacizumab lived without disease progression or death vs. those taking bevacizumab alone.

The results, including biomarker sub-group analyses, will be presented at a forthcoming medical meeting. The safety and tolerability profiles observed in PAOLA-1 were generally consistent with those known for each medicine. PAOLA-1 is the second positive Phase III trial with Lynparza in 1st-line advanced ovarian cancer.

PAOLA-1 is an ENGOT (European Network for Gynecological Trial) trial, sponsored by ARCAGY Research (Association de Recherche sur les Cancers dont Gynecologiques) and GINECO (Groupe d'Investigateurs National des Etudes des Cancers Ovariens et du sein).

ARCAGY-GINECO is an academic group specialised in clinical and translational research in women's cancers and a member of the GCIG (Gynecologic Cancer InterGroup).

Lynparza is currently approved as first-line maintenance treatment in BRCAm advanced ovarian cancer following response to platinum-based chemotherapy.

It is also approved for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status. It is also approved for germline BRCAm HER2-negative metastatic breast cancer previously treated with chemotherapy.

For first-line maintenance in advanced ovarian cancer and the metastatic breast cancer setting, physicians should select patients for therapy based on an FDA-approved companion diagnostic.

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