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Pfizer Files for Xtandi in Early Stage Prostate Cancer

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Pfizer Inc. (PFE - Free Report) and its Japanese partnerAstellas Pharma Inc. announced detailed results from a late-stage study which can expand the label of its prostate cancer drug Xtandi to include early-stage patients.

Detailed data from the phase III PROSPER study on Xtandi showed that treatment with the combination of Xtandi (enzalutamide) and androgen deprivation therapy (“ADT”) reduced the risk of metastases or death by 71% compared with ADT alone in men with castration-resistant non-metastatic prostate cancer (“CRPC”).

In the double-blind study, the median metastasis-free survival (MFS) — the primary endpoint — was 36.6 months with Xtandi plus ADT versus 14.7 months with ADT alone. We remind investors that top-line data from the PROSPER study was presented by Pfizer/Astellas in September 2017.

Based on the results of the study, the company made regulatory filings in the United States and EU.

PROSPER study also investigated time to prostate-specific antigen (“PSA”) progression, time to first use of new antineoplastic therapy and overall survival as key secondary endpoints. There was a 93% reduction in the risk of PSA progression in the Xtandi arm compared with ADT alone. The median time to PSA progression in the Xtandi group was 37.2 months compared with 3.9 months for 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 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.

Pfizer’s shares have underperformed the industry over a year. The stock has returned 8.1% during this period, comparing unfavorably with an increase of 13.9% for the industry.



Xtandi was added to Pfizer’s portfolio with the acquisition of Medivation in September 2017. While Pfizer sells Xtandi in the United States in partnership with Astellas, the latter owns the marketing right outside the U.S. markets. Pfizer recorded Xtandi alliance revenues of $590 million in 2017.



Zacks Rank & Other Stocks to Consider

Pfizer carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the health care space are XOMA Corp (XOMA - Free Report) , Exelixis (EXEL - Free Report) and Sucampo . All of them carry a Zacks Rank #2, each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Exelixis’ earnings per share estimates have moved up from 72 cents to 77 cents for 2018 in the last 60 days. The company delivered positive earnings surprise in the last four quarters, with an average beat of 572.92%. Share price of the company surged 42.1% over a year.

XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 in the last 60 days. The company pulled off a positive earnings surprise in one of the last four quarters, with an average beat of 47.92%. Share price of the company skyrocketed 503.7% over a year.

Sucampo delivered a positive earnings surprise in three of the last four quarters, with an average beat of 15.63%. Share price of the company surged 54.5% over a year.

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