AstraZeneca and Merck have secured regulatory approval for Lynparza (olaparib) to treat patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer in the European Union (EU).

Lynparza is an advanced PARP inhibitor and a targeted treatment designed to block the DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair, including mutations in BRCA1 and/or BRCA2.

The drug was approved as a monotherapy for the maintenance treatment of germline BRCA1/2 mutations in adult patients with metastatic adenocarcinoma of the pancreas and has not progressed after a minimum of 16 weeks of platinum treatment within a 1st-line chemotherapy regimen.

Lynparza has been approved in the US and several other countries as a first-line maintenance treatment for gBRCAm metastatic pancreatic cancer and being reviewed for regulatory approval in other territories.

‎AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “Patients with metastatic pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and few treatment advances have been made over the last few decades.

“In the POLO trial, Lynparza nearly doubled median progression-free survival versus placebo after 1st-line chemotherapy for patients with germline BRCA-mutated metastatic pancreatic cancer.

“This approval underscores the importance of testing all patients for germline BRCA mutations at the time of diagnosis, as it will help inform personalised treatment options for patients in the EU.”

The EU approval of Lynparza is based on results from the Phase 3 POLO trial

The EU regulatory approval of Lynparza was supported by the results from the Phase 3 POLO trial, following the recommendation for approval by the European Medicines Agency (EMA’s) Committee for Medicinal Products for Human Use (CHMP).

POLO is a randomised, double-blinded, placebo-controlled, multi-centre Phase 3 clinical study of Lynparza tablets as maintenance monotherapy, compared to placebo.

The clinical trial randomised 154 patients with gBRCAm metastatic pancreatic cancer whose disease had not progressed on 1st-line platinum-based chemotherapy.

Progression-free survival was the primary endpoint and overall survival, time to second disease progression, overall response rate and health-related quality of life included the key secondary endpoints.

The clinical study showed that the Lynparza has almost doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death compared to placebo. The safety and tolerability profile of the drug was consistent with previous trials.

POLO trial co-principal investigator Hedy Kindler said: “Today’s approval opens the door to a new era of biomarker-led care for patients with metastatic pancreatic cancer in the EU, which has the highest incidence of any region globally.

“Lynparza now provides clinicians with a targeted, well-tolerated treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer.”