AstraZeneca plc AZN and partner Merck MRK announced that a phase III study evaluating a combination regimen of their successful PARP inhibitor, Lynparza in patients with platinum-sensitive relapsed ovarian cancer failed to meet the primary endpoint
The GY004 study was led by NRG Oncology and sponsored by the U.S. National Cancer Institute (NCI) and evaluated the safety and efficacy of a potential new medicine cediranib added to Lynparza versus platinum-based chemotherapy in the above patient population.
The study failed to show a statistically significant improvement in progression-free survival (PFS) with cediranib (an oral VEGF receptor inhibitor) added to Lynparza in the intent-to-treat (ITT) population, thereby not meeting the primary endpoint
Shares of AstraZeneca and Merck declined 8.6% and 6.1%, respectively on Thursday in response to the news and also due to coronavirus related market sell-off. In the past year, shares of AstraZeneca and Merck have declined 18.3% and 18.2%, respectively compared with the industry’s decrease of 9.9%.
Lynparza, presently marketed for advanced ovarian cancer and breast cancer, has also been evaluated for other tumor types including prostate and pancreatic cancers and is in clinical development for earlier-line settings for ovarian cancer and breast cancer. A regulatory application seeking approval for use of Lynparza tablets in BRCA-mutated pancreatic cancer was approved by the FDA in December 2019 with a similar decision in the EU expected in the first half of 2020.
Lynparza is also under priority review in the United States for metastatic castration-resistant prostate cancer (with HRR genetic mutations) and for first-line advanced ovarian cancer (maintenance therapy) in combination with Roche’s RHHBY Avastin regardless of patients’ biomarker status or surgical outcome.
Lynparza, which is being jointly developed and commercialized by AstraZeneca and Merck, generated product sales of $1.2 billion for AstraZeneca and alliance revenues of $444 million for Merck in 2019.
Other PARP inhibitors available in the market are Glaxo’s GSK, Zejula, Pfizer’s Talzenna and Clovis Oncology’s Rubraca.
Both Merck and AstraZeneca carry 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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