AstraZeneca (AZN - Free Report) and Merck’s (MRK - Free Report) 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 - Free Report) Rubraca and Tesaro, Inc.’s (TSRO - Free Report) 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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