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Study success strengthens case for Lynparza in ovarian cancer

(Credit: AstraZeneca )
  • Adding AstraZeneca’s Lynparza to Roche’s older cancer drug Avastin helped women with advanced ovarian cancer live longer without their tumors growing, according to results from a Phase 3 study disclosed Wednesday by AstraZeneca.
  • In the trial, called PAOLA-1 and sponsored by two academic groups in Europe, women were given Lynparza following initial treatment with Avastin and followed to determine whether AstraZeneca’s drug could extend the time without disease worsening or death.
  • By topline outcome, the study was a success: women given Lynparza after Avastin experienced longer progression-free survival than those on Avastin alone, a standard treatment. Notably, both women with and without BRCA mutations were included, suggesting possibly broader use for Lynparza than its current first-line, BRCA-limited approval.

Lynparza (olaparib) is the most commonly used drug in its class, a group of cancer treatments known as PARP inhibitors.

Its initial U.S. approval as a first-line maintenance therapy, granted in late December by the Food and Drug Administration, has helped AstraZeneca extend its lead over rival PARP drugs sold by GlaxoSmithKline and Clovis Oncology.

Data supporting that OK, which came from a study called SOLO-1, showed a dramatic benefit with Lynparza. Compared to placebo, the drug reduced the risk of disease progression or death by 70% when given as maintenance therapy following platinum-based chemotherapy.

Roche’s Avastin (bevacizumab) is commonly used by physicians as an initial treatment for advanced ovarian cancer, making the results disclosed Wednesday potentially helpful to AstraZeneca as it works to convince doctors of Lynparza.

“Physicians are quite well used to using Avastin and they will happily combine it with Lynparza, if indeed PAOLA is positive,” said AstraZeneca CEO Pascal Soriot in a recent earnings conference call held before the study’s results were disclosed.

Soriot noted roughly half of ovarian cancer patients in the U.S. currently receive Avastin as an initial treatment, as do as many as 60% in Europe.

PAOLA-1, begun in May 2015, enrolled over 800 women, according to a federal database of clinical trials. Unlike the earlier SOLO-1 study, however, it included patients without BRCA mutations, a genetic error that makes PARP inhibitors more likely to be effective.

No detailed data were released Wednesday, making it hard to judge whether the positive progression-free survival benefit was clear in both BRCA-positive and BRCA-negative groups.

AstraZeneca said it would present full results, including biomarker analyses, at a forthcoming medical meeting. The pharma also plans to discuss the results with health authorities.

PAOLA-1’s success comes at a good time for AstraZeneca. Last month, GlaxoSmithKline announced that its Phase 3 PRIMA study showed its competing PARP inhibitor, Zejula (niraparib), extended progression-free survival versus placebo when used as maintenance therapy following chemotherapy.

Then, GSK R&D chief Hal Barron argued women with ovarian cancer needed more first-line options, as only about 15% of the 300,000 diagnosed each year are currently eligible for PARP inhibitors initially.

Lynparza is also approved in certain breast cancers, and earlier this month posted positive results in men with a specific form of metastatic castration-resistant prostate cancer. 

It’s one of AstraZeneca’s most important drugs and, alongside the lung cancer medicine Tagrisso (osimertinib), a major part of the British pharma’s oncology push.