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Pfizer Amends Xtandi Study Protocols to Speed Up Completion

Zacks Equity Research logoZacks Equity Research 8/23/2018 Zacks Equity Research

Pfizer Inc. PFE and its Japanese partner Astellas Pharma announced that they have amended protocols for two registrational phase III studies — ARCHES and EMBARK — evaluating prostate cancer drug, Xtandi (enzalutamide) in a an expanded patient population.

The amendments have been done to accelerate the anticipated completion timeline for both the studies. The expected primary completion timeline for the ARCHES study is now late 2018 compared with its earlier anticipated date of April 2020. The companies also expect the EMBARK study to be completed by mid-2020. The previously expected completion date for EMBARK study was March 2021.

Both the studies are evaluating Xtandi in men with hormone-sensitive prostate cancer (“HSPC”). The ARCHES study will evaluate Xtandi in combination with androgen deprivation therapy (“ADT”) compared to ADT alone in metastatic HSPC patients. The primary endpoint of the study is radiographic progression-free survival.

The EMBARK study is evaluating Xtandi as monotherapy or in combination with leuprolide compared to leuprolide alone in high-risk non-metastatic HSPC patients. The study’s primary endpoint is metastasis-free survival.

Enrollment was completed in both the studies earlier this year.

Xtandi is already approved in the United States for the treatment of castration-resistant prostate cancer. Pfizer gets royalties from Astellas on the sales of the drug, which is recorded as alliance revenues. Pfizer’s Xtandi alliance revenues increased 21% from the year-ago period to $330 million in the first six months of 2018.

In July, Xtandi’s U.S. label was expanded to include men with non-metastatic castration-resistant prostate cancer. Prior to this, Xtandi was approved for the treatment of metastatic CRPC in patients who have previously received docetaxel. Successful development of the drug in these label expansion studies will help to address a broader spectrum of prostate cancer patients by including hormone-sensitive patients.

This year so far, Pfizer’s shares have increased 16.1% compared with an increase of 5.2% for the industry.

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In a separate development, the company inked an agreement with Exact Sciences Corp. EXAS to co-promote the latter’s DNA screening test, Cologuard. The test is approved by the FDA for early detection of colorectal cancer.

Pfizer Inc. Price

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Zacks Rank & Stocks to Consider

Pfizer currently has a Zacks Rank #3 (Hold).

A couple of better-ranked stocks from the same space are Bristol-Myers Squibb Company BMY and Eli Lilly and Company LLY. While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), Lilly carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings per share estimates have increased from $3.43 to $3.59 for 2018 and from $3.66 to $3.83 for 2018 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.39%.

Lilly’s earnings per share estimates have increased from $5.16 to $5.42 for 2018 and from $5.55 to $5.65 for 2018 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 10.15%. The stock has rallied 24.4% so far this year.

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