AstraZeneca and MSD have reported that the Phase III PAOLA-1 study of Lynparza (olaparib) in combination with bevacizumab met the primary endpoint in advanced ovarian cancer patients.
The clinical trial compared the combination therapy to bevacizumab alone in the first-line maintenance setting in patients with or without BRCA gene mutations.
PAOLA-1 enrolled women who achieved a complete or partial response when treated with first-line therapy of platinum-based chemotherapy and bevacizumab.
In the intent-to-treat population, Lynparza plus bevacizumab led to a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS).
This means that women on the combination lived longer without disease progression or death compared to patients treated with only bevacizumab.
The safety and tolerability profiles in the Phase III study were also found to be generally consistent with those established for individual medicines.
AstraZeneca Oncology R&D executive vice-president José Baselga said: “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 first-line maintenance treatment for women with advanced ovarian cancer.”
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor designed to inhibit DNA damage response (DDR) in tumours with a homologous recombination repair deficiency.
AstraZeneca is developing Lynparza in alliance with MSD as a monotherapy and in combination with other drugs for the treatment of PARP-dependent tumours.
The drug has approval in 64 countries as maintenance therapy for platinum-sensitive relapsed ovarian cancer. It is also indicated in certain markets to treat BRCA-mutated advanced ovarian cancer that responded to previous platinum-based chemotherapy.
Lynparza holds regulatory authorisation in 43 countries for previously treated germline BRCA-mutated, HER2-negative, metastatic breast cancer.