8 July 2020 - - LYNPARZA has been approved in the European Union as a monotherapy for the maintenance treatment of 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, UK-based AstraZeneca and US-based Merck (NYSE: MRK) said.

The approval by the European Commission was based on results from the Phase 3 POLO trial, which were published in The New England Journal of Medicine.

It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

Pancreatic cancer is a rare, life-threatening disease with the lowest survival rate of the most common cancers. Approximately 5-7% of patients with metastatic pancreatic cancer have a germline BRCA mutation.

The POLO trial demonstrated 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 (HR 0.53 [95% CI 0.35-0.81] p=0.0035).

The safety and tolerability profile of LYNPARZA in the POLO trial was consistent with previous trials. The most common adverse reactions ≥10% were fatigue/asthenia, nausea, abdominal pain, diarrhea, anemia, decreased appetite, constipation, vomiting, back pain, arthralgia, rash, thrombocytopenia, dyspnea, neutropenia, nasopharyngitis, dysgeusia and stomatitis.

The most common ≥ Grade 3 ARs were anemia, fatigue/asthenia, decreased appetite, abdominal pain, vomiting and arthralgia. Among patients taking LYNPARZA, dose interruptions due to an AR of any grade occurred in 35% and dose reductions due to an AR occurred in 17%. Discontinuation due to ARs occurred in 6% of patients receiving LYNPARZA.

LYNPARZA is approved in the US and several 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, based on the Phase 3 POLO trial, with ongoing regulatory reviews in other jurisdictions.