AstraZeneca/Merck's Lynparza Betters Survival in Phase III

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AstraZeneca AZN and Merck's MRK cancer tablet, Lynparza demonstrated significant delay in disease progression in a late-stage study evaluating it for the first-line treatment of advanced ovarian cancer.

The phase III SOLO-1 study (n=391) met the primary endpoint demonstrating that first-line treatment with Lynparza maintenance therapy led to a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) compared to placebo in women with BRCA-mutated (BRCAm) advanced ovarian cancer. Meanwhile, the PARP inhibitor demonstrated a well-characterized safety and tolerability profile in the study.

Full data from the SOLO-1 study will be presented at a future medical meeting. The companies plan to conduct discussions related to submissions to get Lynparza approved in the first-line maintenance setting with regulatory authorities. If approved for expanded use in the first-line setting, sales of Lynparza can improve in the future quarters.

Lynparza is presently marketed for advanced ovarian cancer in later settings. In January, Lynparza became the first PARP-inhibitor to be approved for a breast cancer indication in the United States. Lynparza is also in different studies for a range of tumor types including breast, prostate and pancreatic cancers as well as earlier-line settings for ovarian cancer.

In the first quarter of 2018, Lynparza sales rose 100% to $119 million. Sales in the United States surged 144%, gaining from recent label expansion approvals in ovarian cancer, tablets, and breast cancer indication. In Europe, sales rose 44%, pushed higher by a number of successful launches, high BRCA-testing rates and encouraging levels of reimbursement.

Clovis Oncology, Inc.'s CLVS Rubraca and Tesaro, Inc.'s TSRO Zejula are the other PARP inhibitors, which pose competition for Lynparza in the United States.

AstraZeneca's shares have risen 0.5% so far this year while Merck's stock is up 7.9%. In contrast, the industry has declined 4.9%.

Both AstraZeneca and Merck have a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

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This article appears in: Investing , Business , Stocks
Referenced Symbols: AZN , MRK , CLVS ,

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