AstraZeneca and MSD have announced positive results from the Phase III PAOLA-1 trial testing Lynparza (olaparib) in women with advanced ovarian cancer.
The company stated that the trial evaluated the drug added to standard-of-care (SoC) 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 (PFS), increasing the time women taking Lynparza plus bevacizumab lived without disease progression or death vs. those taking bevacizumab alone.
The safety and tolerability profiles observed in PAOLA-1 were also generally consistent with those known for each medicine, making the study the second positive Phase III trial with Lynparza in 1st-line advanced ovarian cancer.
José Baselga, executive vice president, Oncology R&D, said that the positive results from the trial demonstrate a “clear potential benefit of adding Lynparza to the standard-treatment bevacizumab for women with advanced ovarian cancer.”
He continued, “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.”
The companies announced earlier this month that the drug was also successful in prostate cancer, after it met its p primary endpoint in a Phase III prostate cancer trial for patients who have a homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new hormonal anticancer treatments (e.g. enzalutamide and abiraterone).
Ovarian cancer is the eighth most common cause of death from cancer in women worldwide, with nearly 300,000 new cases diagnosed and around 185,000 deaths in 2018 alone.
Most women are diagnosed with advanced (Stage III or IV) ovarian cancer and have a five-year survival rate of approximately 30%.