The EC approval allows using Lynparza as a maintenance treatment for adult patients with germline BRCA1/2 mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.
Lynparza, a first-in-class PARP inhibitor, is said to be the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies such as BRCA mutations to selectively eliminate cancer cells.
Merck Research Laboratories chief medical officer, global clinical development head and senior vice president Dr Roy Baynes said: “Lynparza is now the only approved PARP inhibitor in biomarker-selected patients with metastatic pancreatic cancer. We look forward to making this targeted treatment option available for patients across the EU as quickly as possible.”
The approval was based on data from the POLO trial, which is a phase 3, randomised, double-blinded, placebo-controlled and multi-centre study of Lynparza tablets (300 mg twice daily) as maintenance monotherapy against placebo.
According to the company, the POLO study showed that Lynparza nearly doubled the time patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 months on placebo.
The study randomised 154 patients with gBRCAm metastatic pancreatic cancer whose disease had not progressed on first-line platinum-based chemotherapy. Patients have been randomised in 3:2 ratio to secure Lynparza or placebo until disease progression.
The progression-free survival is the primary endpoint while the secondary endpoints include overall survival, time to second disease progression, overall response rate and health-related quality of life.
Lynparza secured approval in the US and various other countries as a first-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “In the POLO trial, Lynparza nearly doubled median progression-free survival versus placebo after first-line chemotherapy for patients with germline BRCA-mutated metastatic pancreatic cancer.”
In May, AstraZeneca entered into an agreement with Oxford University for the development of a vaccine to prevent Covid-19 disease.