Pfizer's Xtandi delays prostate cancer spread in early stage disease
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[February 06, 2018] By
Bill Berkrot
(Reuters) - Use of Xtandi in early stage
prostate cancer on top of standard hormone therapy reduced the risk of
disease spreading or death by 71 percent compared with hormone therapy
alone, study results that could lead to significantly increased sales of
the Pfizer Inc and Astellas Pharma Inc medicine.
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The data from a highly anticipated study released on Monday showed
that it took 36.6 months for the disease to spread to other parts of
the body in patients who received Xtandi plus androgen deprivation
therapy (ADT), a measure known as median metastasis-free survival.
That compared with 14.7 months for ADT alone, a highly statistically
significant difference of nearly two years.
Subjects in the 1,400-patient study were deemed at elevated risk of
developing metastases in the bones or elsewhere.
"The findings from the trial are quite impressive in terms of
delaying the visibility of the cancer," said Dr. Maha Hussain, the
study's lead investigator who will present the data at a cancer
meeting in San Francisco later this week.
She noted that current treatments for this patient population are
not life prolonging or significantly impactful, so there is a high
unmet need for delaying development of metastases and progression to
advanced cancer.
"The data is very likely practice changing," added Hussain, from the
Robert H Lurie Comprehensive Cancer Center of Northwestern
University.
That would be good news for Pfizer and Astellas, providing a
lucrative new outlet for Xtandi. The data has been submitted for
review to U.S. and European regulators, the companies said.
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Xtandi and rival drug Zytiga from Johnson & Johnson are currently
approved for advanced cancer that has spread beyond the prostate.
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"The treatment opportunities are almost double than the current
indication," Pfizer Chief Operating Officer Albert Bourla told
Reuters in a recent telephone interview. "And the financial interest
is larger because the duration of treatment is longer."
Prostate cancer is the second most common cancer in men worldwide.
More than 164,000 men in the United States are estimated to be newly
diagnosed with it this year.
![](http://archives.lincolndailynews.com/2018/Feb/06/images/ads/current/napa_bch1-3108.png)
Adverse side effects were similar to those reported in previous
Xtandi trials of more advanced cancer patients, the companies said.
About 9 percent of patients in the Xtandi arm discontinued treatment
due to side effects compared with 6 percent of those on ADT alone.
Major adverse cardiovascular events, such as heart attack, were
reported in 5 percent of Xtandi plus ADT patients versus 3 percent
with ADT.
Xtandi also significantly delayed median time to prostate-specific
antigen (PSA) progression, a biomarker tied to disease worsening -
33.3 months versus 3.9 months.
Overall survival data was not yet available.
(Reporting by Bill Berkrot; Editing by Lisa Shumaker)
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