Only PARP Inhibitor to Demonstrate Patient Benefit in a Phase 3 Trial in This Setting

KENILWORTH, N.J.--(BUSINESS WIRE)--

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending LYNPARZA for approval as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2 mutations (gBRCAm) 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.

The CHMP based its positive opinion on results from the Phase 3 POLO trial, which were previously published in The New England Journal of Medicine.

The trial demonstrated LYNPARZA nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo (HR 0.53 [95% CI 0.35-0.82]p=0.004).

The safety and tolerability profile of LYNPARZA in the POLO trial was consistent with previous trials. The most common adverse reactions (ARs) ≥10% were fatigue/asthenia (60%), nausea (45%), abdominal pain (34%), diarrhea (29%), anemia (27%), decreased appetite (25%), constipation (23%), vomiting (20%), back pain (19%), arthralgia (15%), rash (15%), thrombocytopenia (14%), dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia (11%), and stomatitis (10%). The most common ≥ Grade 3 ARs were anemia (11%), fatigue/asthenia (5%), decreased appetite (3%), abdominal pain (2%), vomiting (1%) and arthralgia (1%). 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.

Dr. JoséBaselga, executive vice president, oncology R&D, AstraZeneca, said, “Patients with advanced pancreatic cancer have seen limited treatment advances over the last few decades. We are now one step closer to potentially bringing the first targeted medicine to certain biomarker-selected patients with advanced pancreatic cancer in the EU.”

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, “A pancreatic cancer diagnosis is devastating, and we are committed to research that aims to change the prognosis for patients. The POLO trial demonstrated that treatment with LYNPARZA extended time without disease progression in certain patients with advanced pancreatic cancer – we are hopeful that we will be able to bring this treatment to patients in the EU soon.”

LYNPARZA is approved in the U.S. 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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

There are no contraindications for LYNPARZA.

WARNINGS AND PRECAUTIONS

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in