Drug Tasquinimod May Improve Survival in Men with
Metastatic Prostate Cancer
An oral therapy that activates the body's immune
system to fight cancer, also known to block tumor blood vessel growth
Nov. 19, 2013 - An investigational prostate cancer
treatment slows the disease's progression and may increase survival,
especially among men whose cancer has spread to the bones, according an
analysis led by the Duke Cancer Institute. The drug tasquinimod, a new
candidate for treating advanced and recurrent prostate cancer, adds
long-term survival and safety data.
"While all subgroups in the clinical trial
benefited from tasquinimod, those whose cancer metastasized to their
bones had the greatest benefit in terms of delaying the time from the
start of treatment to when the cancer progressed," said lead author
Andrew J. Armstrong, M.D., ScM, associate professor of medicine at the
Duke Cancer Institute.
"This group of men also seemed to have a longer
survival benefit when we followed them over several years."
The study was published on Nov. 19, 2013, in the
journal Clinical Cancer Research.
Tasquinimod, a drug in development by Active
Biotech in partnership with Ipsen, is an oral therapy that activates the
body's immune system to fight cancer. Its mechanism is not fully
understood, but it appears to affect the function of myeloid-derived
suppressor cells, which are found in increased numbers in cancer
patients. Tasquinimod is also known to block tumor blood vessel growth,
a process termed angiogenesis.
New treatments approved in recent years have given
physicians and patients additional options to fight prostate cancer, but
the therapies typically only extend patients' lives by three to five
months. New drugs that increase survival without serious side effects
are still needed.
In this phase II clinical trial, funded by Active
Biotech, researchers studied the use of tasquinimod among men with
metastatic castration-resistant prostate cancer, an advanced form of the
disease that does not respond to hormonal therapy. The study enrolled
201 men who were followed for approximately three years, with 134
randomly assigned to receive tasquinimod and 67 given placebo.
The researchers measured patients' overall
survival, whether their cancer progressed, and the drug's safety and
tolerability. They also conducted studies of biomarkers to better
understand how tasquinimod stimulates the immune system.
Armstrong and his colleagues found that men taking
tasquinimod saw no cancer progression for an average of 7.6 months,
compared with 3.3 months for placebo. Men whose cancer had already
metastasized to their bones and took tasquinimod remained
progression-free for even longer 8.8 months, compared with 3.4 months
"By delaying the onset of symptoms or growth of
metastatic tumors, tasquinimod may allow men to put off other
treatments, such as chemotherapy, and maintain a high quality of life,"
Armstrong said. "That's an important goal for many patients and
Men taking tasquinimod survived 33.4 months on
average, versus 30.4 months with placebo. However, those whose cancer
had already metastasized to their bones survived an average of 34.2
months, compared with 27.1 months for placebo, a seven-month difference.
This improvement in survival with tasquinimod persisted when statistical
adjustments were made for other factors such as PSA level, PSA doubling
time, lactate dehydrogenase (LDH) levels, and the presence of anemia,
each of which were important prognostic factors.
The researchers also identified certain predictors
of who would benefit most from tasquinimod, such as lower baseline PSA
levels or other biomarkers.
The treatment was considered safe with low to
moderate side effects, which included mild gastrointestinal issues,
muscle and joint pains, and fatigue.
Based on results from the phase II clinical trial,
tasquinimod is now being evaluated in an international phase III trial
focusing on men whose prostate cancer has spread to their bones and
become resistant to hormonal therapies.
"We still need to do more research to understand
the efficacy and mechanism of action of tasquinimod, who benefits the
most from it, how it fits into a treatment regimen, and how it could be
used in combination with other therapies," Armstrong said. "In addition,
tasquinimod is not a prostate cancer-specific drug. If the phase III
trial shows that tasquinimod is effective and safe, this opens the door
for evaluating the immunotherapy in other cancers."
Armstrong and Pili received research funding from
Active Biotech. Nordle and Forsberg are employees and shareholders of
Active Biotech. The research was conducted within the Department of
Defense Prostate Cancer Clinical Trials Consortium, a 13-site clinical
research group working to design, implement and complete phase I and
phase II trials in prostate cancer.
In addition to Armstrong, study authors include
Michael Hδggman of University Hospital of Uppsala in Sweden; Walter
Stadler of the University of Chicago; Jeffrey Gingrich of the University
of Pittsburgh; Vasily Assikis of Peachtree Hematology Oncology
Consultants in Atlanta; Jonathan Polikoff of Kaiser Permanente Medical
Group in San Diego; Jan-Erik Damber of Sahlgrenska University Hospital
in Sweden; Laurence Belkoff of Urologic Consultants of Southeastern
Pennsylvania; Örjan Nordle and Göran Forsberg of Active Biotech AB;
Michael Carducci of Sidney Kimmel Comprehensive Cancer Center at Johns
Hopkins University; and Roberto Pili of Roswell Park Cancer Institute in
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