AstraZeneca/Merck's Lynparza Meets Endpoint in POLO Study
AstraZeneca plc AZN and partner Merck’s MRK PARP inhibitor, Lynparza met the primary endpoint in a late-stage study evaluating it as first-line maintenance treatment in germline BRCA-mutated metastatic pancreatic cancer. Data from the POLO study showed that treatment with Lynparza tablets (300mg twice daily) led to statistically-significant and clinically-meaningful improvement in the primary endpoint of progression-free survival compared to placebo.
Lynparza is presently approved for multiple indications in advanced ovarian cancer and metastatic breast cancer. It became the first PARP inhibitor to show positive data in a study in germline BRCA-mutated metastatic pancreatic cancer. Other PARP inhibitors available in the market are Tesaro’s Zejula and Clovis Oncology, Inc.’s CLVS Rubraca, both are not approved in pancreatic cancer indications. Tesaro is now part of GlaxoSmithKline GSK.
Please note that the FDA has granted orphan drug designation (ODD) to Lynparza for the treatment of pancreatic cancer. Full data from the study is expected to be presented at a future medical meeting.
AstraZeneca reported Lynparza sales of $647 million in 2018, up 116% at constant exchange rates, on expanded use in ovarian cancer and label expansion in breast cancer. The approval of Lynparza in December last year as a first-line treatment of patients with BRCAm ovarian cancer in the United States is expected to support further expanded use.
This year so far, AstraZeneca’s shares have risen 10.5%.
Lynpazra is a key new drug in AstraZeneca’s oncology portfolio together with Tagrisso and Imfinzi. Oncology sales now comprise almost 30% of total product sales for AstraZeneca and rose 49% in 2018.
AstraZeneca currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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