Pfizer, Inc. (PFE - Free Report) and its Japanese partner Astellas announced that their prostate cancer drug Xtandi met the primary endpoint in a late-stage study, which can expand the label of the drug to include early-stage patients.
Top-line data from the phase III PROSPER study showed that treatment with Xtandi plus androgen deprivation therapy (ADT) led to a statistically significant improvement in metastasis-free survival (MFS) – the primary endpoint - in men with castration-resistant non-metastatic prostate cancer (CRPC) compared to ADT alone.
Many prostate cancer patients with non-metastatic CRPC – an earlier stage of prostate cancer – can experience disease progression despite ADT. However, presently no FDA approved treatment options are available to cater to this condition until these patients develop metastatic disease.
Xtandi is presently approved for the treatment of metastatic CRPC in patients who have previously received docetaxel. If approved for the non-metastatic patient population, the label of Xtandi can be expanded to cover all patients with CRPC.
Shares of Pfizer were up almost 2% in response to the positive news. However, Pfizer’s shares have underperformed the industry this year so far. The stock has returned 10% during this period, comparing unfavorably with an increase of 16% for the industry.
Pfizer plans to discuss the PROSPER study data with the FDA and other regulatory authorities and also present detailed data at a future medical meeting.
Xtandi was added to Pfizer’s portfolio with the acquisition of Medivation in September. While Pfizer sells Xtandi in the United States in partnership with Astellas, the latter owns the marketing right outside U.S. markets. Pfizer recorded Xtandi alliance revenues of $141 million in the second quarter and $131 million in the first.
In December 2016, Pfizer and Astellas had announced that a phase IV study — PLATO — evaluating the efficacy and safety of continued treatment with Xtandi did not meet the primary endpoint. The PLATO study evaluated Xtandi plus Johnson & Johnson’s (JNJ - Free Report) Zytiga and prednisone compared to Zytiga and prednisone alone.
Xtandi is a key drug in Prizer’s oncology portfolio/pipeline. The New York-based pharma giant is aggressively working on expanding the labels of its marketed cancer drugs like Xtandi, Ibrance and Xalkori.
Xtandi is in several studies including late-stage studies in hormone-sensitive prostate cancer. It is also in mid-stage development for the treatment of advanced breast cancer and hepatocellular carcinoma.
Pfizer carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Stocks to Consider
Better-ranked drug/biotech stocks include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , both with a Zacks Rank #1.
Shares of Alexion are up 18.2% year to date. The Zacks Consensus Estimate for 2017 and 2018 have climbed 5.8% and 6.4%, respectively, over the past 60 days.
Regeneron’s shares up 20.2% this year so far. Its estimates have moved up 16.8% for 2017 while that for 2018 have increased 8.2% over the past 60 days.
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