AstraZeneca and Merck have presented full progression-free survival (PFS) results from the Phase III PAOLA-1 study of their PARP inhibitor Lynparza (olaparib) in newly-diagnosed ovarian cancer patients at the European Society of Medical Oncology congress.
When combined with the current standard of care, bevacizumab, Lynparza reduced the risk of disease progression or death by 41% compared to bevacizumab alone. The Lynparza-bevacizumab also improved PFS, the primary endpoint of the study, by a median of 22.1 months, compared to 16.6 months for bevacizumab alone.
Also, two-years after the initiation of the trial, 46% of women treated with Lynparza plus bevacizumab showed no disease progression, compared to 28% who received the standard of care alone.
Although the PAOLA-1 study studied ovarian cancer patients regardless of their genetic biomarker status or outcome from previous surgery, AstraZeneca and Merck also carried out two sub-group analyses on BRCA-mutated (BRCA-m) and broader homologous recombination deficiency (HRD) populations.
In the BRCA-m population, Lynparza plus bevacizumab lowered the risk of disease progression or death by 69% and PFS was 37.2 months, compared to 21.7 months for bevacizumab alone.
PFS was also 37.2 months for the broader HRD sub-population, compared to 17.7 months for the standard of care alone. This population also experienced a 67% reduction in risk of disease progression or death when treated with Lynparza plus bevacizumab.
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The safety and tolerability of the combination was consistent with previous studies, and the companies claimed the drugs caused no detriment to patients’ quality of life.
AstraZeneca Oncology research and development executive vice-president José Baselga said: “This trial was designed to reflect everyday clinical practice using a global standard of care treatment with Lynparza.
The results showed at two years nearly half of women with advanced ovarian cancer were progression-free with Lynparza added to bevacizumab as a 1st-line maintenance treatment, regardless of their biomarker status or surgical outcome.
“We are working with regulatory authorities to bring Lynparza to these patients as quickly as possible.”
Merck chief medical officer, senior vice-president and head of global clinical development Roy Baynes said: “PAOLA-1 is the second positive Phase III trial involving Lynparza in the 1st-line maintenance setting for advanced ovarian cancer.
Following the positive SOLO-1 trial, we are encouraged by the PAOLA-1 results which reaffirm AstraZeneca and MSD’s ongoing commitment to explore potential treatment options for more women with ovarian cancer.”
Lynparza is already approved to treat platinum-sensitive relapsed, advanced ovarian cancer, as well as metastatic breast cancer previously treated with chemotherapy.