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Pfizer Amends Xtandi Study Protocols to Speed Up Completion
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Pfizer Inc. (PFE - Free Report) 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.
In a separate development, the company inked an agreement with Exact Sciences Corp. (EXAS - Free Report) to co-promote the latter’s DNA screening test, Cologuard. The test is approved by the FDA for early detection of colorectal cancer.
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.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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Pfizer Amends Xtandi Study Protocols to Speed Up Completion
Pfizer Inc. (PFE - Free Report) 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.
In a separate development, the company inked an agreement with Exact Sciences Corp. (EXAS - Free Report) 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
Pfizer Inc. Price | Pfizer Inc. Quote
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 - Free Report) and Eli Lilly and Company (LLY - Free Report) . 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.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>