| Sept 12
Sept 12 Bristol-Myers Squibb Co's
immunotherapy drug Yervoy failed to significantly prolong
survival among patients with advanced prostate cancer who had
previously received chemotherapy, according to limited data from
the first late-stage study of the drug for the condition.
Yervoy (ipilimumab) frees the immune system to attack and
kill cancer cells by blocking the action of a protein called
CTLA-4. The closely followed drug was approved in 2011 to treat
melanoma, the most deadly form of skin cancer, and is well on
its way to achieving annual blockbuster sales of $1 billion.
An abstract, or limited summary, of findings from the
prostate cancer study was released on Thursday. The trial
involved almost 800 patients that had failed to benefit from
drugs that lower the amount of testosterone - the male hormone
that fuels prostate cancer - and from treatment with a standard
chemotherapy called docetaxel.
Half the patients in the trial received Yervoy after
treatment with a dose of radiation, while others received a
placebo after radiation.
Patients taking Yervoy lived, on average, 11.2 months,
compared with 10 months for those in the placebo group, a
difference that was deemed slightly below statistical
Drug-related side effects, including gastrointestinal
problems, were similar to those seen with Yervoy in melanoma
Researchers are slated to present full results of the trial,
nicknamed the "043" study, late this month at a medical meeting
The best responses to Yervoy in the prostate cancer study
were in patients with less-advanced disease, including those
whose cancer had not spread to the lung and liver, according to
That could bode well for a second Phase III trial of Yervoy,
expected to be completed by 2015, which has enrolled patients
who are asymptomatic or have only mild symptoms of prostate
cancer, and whose cancer has not spread to the lungs or liver.
Although previously treated with anti-testosterone drugs, they
have not taken chemotherapy.
One of the leading approved treatments for prostate cancer
is Johnson & Johnson's Zytiga. In trials of patients
that had not previously been treated with chemotherapy, those
taking Zytiga, on average, lived five months longer than those
who received a placebo.
The American Cancer Society last year estimated that more
than 28,000 U.S. men would die from prostate cancer in 2012,
making it the second leading cause of cancer death behind lung
Bristol-Myers is also testing Yervoy, which is given by
infusion, in a variety of other cancers, including those of the
lung, stomach and ovaries.