AstraZeneca’s PAOLA-1 trial met primary endpoint

AstraZeneca and MSD have announced positive results from the Phase III PAOLA-1 trial in women with advanced ovarian cancer.

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

The second positive Phase III trial with Lynparza

The trial met its primary endpoint in the intent-to-treat population with a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), 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.

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“The positive results from the PAOLA-1 trial demonstrate a clear potential benefit of adding Lynparza to the standard-treatment bevacizumab for women with advanced ovarian cancer. Following positive results from the SOLO-1 trial for women with a BRCA gene mutation, the PAOLA-1 trial marks yet another positive Phase III trial for Lynparza as a 1st-line maintenance treatment for women with advanced ovarian cancer. We look forward to discussing the results with global health authorities as soon as possible,” says José Baselga, Executive Vice President, Oncology R&D, AstraZeneca.

PAOLA-1

PAOLA-1 is an ENGOT (European Network of Gynaecological Oncological Trial groups) trial, sponsored by ARCAGY Research (Association de Recherche sur les CAncers dont GYnécologiques) on behalf of GINECO (Groupe d’Investigateurs National des Etudes des Cancers Ovariens et du sein). ARCAGY-GINECO is an academic group specialising in clinical and translational research in patients’ cancers and a member of the GCIG (Gynecologic Cancer InterGroup).

Image showing cancer cells: iStock