The drug is being developed and commercialized jointly by AstraZeneca and Merck. It has already been approved for multiple indications in advanced ovarian cancer and metastatic breast cancer.
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AstraZeneca and its research partner Merck & Company announced positive data from their Phase III POLO trial of Lynparza in pancreatic cancer. Merck is known as MSD outside of the U.S. and Canada.
The companies said that the trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as first-line maintenance therapy alone in patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas in patients who haven’t responded to platinum-based chemotherapy.
The trial compared Lynparza (olaparib) to placebo. POLO is a Phase III randomized, double-blinded, placebo-controlled, multi-center trial of Lynparza tablets (300mg twice daily) alone compared to placebo. It randomized 154 patients with gBRCAm metastatic pancreatic cancer that had not progressed on first-line platinum-based chemotherapy. Patients were randomized three-to-two to receive Lynparza or placebo until the disease progressed.
The primary endpoint of the trial was PFS and key secondary endpoints included overall survival (OS), time to secondary disease progression, overall response rate (ORR), disease control rate and health-related quality of life.
Lynparza is a first-in-class PARP inhibitor. It is the first targeted treatment that blocks DNA damage response in cells and tumors that have a deficiency in homologous recombination repair (HRR), such as BRCA1 and BRCA2 mutations. The drug is being developed and commercialized jointly by AstraZeneca and Merck. It has already been approved for multiple indications in advanced ovarian cancer and metastatic breast cancer.
The two companies inked their research collaboration in July 2017 to develop Lynparza and a potential new drug, selumetinib, a MEK inhibitor, in various cancer types.
“This is the first positive Phase III trial of any PARP inhibitor in germline BRCA-mutated metastatic pancreatic cancer, a devastating disease with critical unmet need,” stated Jose Baselga, AstraZeneca’s executive vice president, Research and Development, Oncology. “The results of POLO provide further evidence of the clinical benefit of Lynparza across a variety of BRCA-mutated tumor types. We will discuss these results with global health authorities as soon as possible.”
The drug was once abandoned by AstraZeneca, but Pascal Soriot, the company’s chief executive officer, brought it back to life when he took over in 2012. Reuters notes that “maintenance therapy means prolonged use and likely higher sales for AstraZeneca, whose new cancer drugs led by Tagrisso, Imfinzi and Lynparza helped it turn around its drug sales.”
Pancreatic cancer is the 12th most common cancer globally. In 2018, 466,000 new cases were diagnosed. Germline BRCA-mutated pancreatic cancer makes up five to seven percent of all cases worldwide. It is the fourth-leading cause of cancer death.
Roy Baynes, senior vice president and Head of Global Clinical Development, chief medical officer, of MSD Research Laboratories, stated, “Trials like POLO demonstrate the shared commitment of MSD and AstraZeneca to assess treatments for difficult-to-treat cancers. The clinically-meaningful results of this trial potentially support the value of testing for germline BRCA mutations in patients with metastatic pancreatic cancer.”
Soriot is one of several biopharma executives testifying before the U.S. Senate Finance Committee about drug pricing today. He will be joined by colleagues and competitors from AbbVie, Bristol-Myers Squibb, Merck & Co., Pfizer, Sanofi and Johnson & Johnson.
