| CHICAGO, June 1
CHICAGO, June 1 U.S. researchers are finalizing
plans to test two immunotherapy drugs made by Bristol-Myers
Squibb Co on patients newly diagnosed with the most
common form of deadly brain tumors in adults.
Dr. Mark Gilbert, a leading brain tumor researcher at
University of Texas MD Anderson Cancer Center in Houston, said
he got approval last Tuesday from the National Cancer Institute
(NCI) to start designing the trial, likely to begin this fall,
with the melanoma drug Yervoy and an experimental drug called
The trial will be run through the nonprofit NRG Oncology, an
NCI sponsored cooperative group of cancer researchers.
"We're really excited about them," said Gilbert, who spoke
in an interview at the American Society of Clinical Oncology
meeting in Chicago.
The hope, he said, is that the drugs, which ramp up the
immune system to fight cancer, will prove effective in treating
the brain tumors known as glioblastomas.
Researchers are already testing Bristol's nivolumab in
patients with a glioblastoma that has come back after standard
treatment, which involves surgery followed by radiation and
Michael Giordano, head of development for oncology and
immunology at Bristol-Myers, said the company's trial in
recurrent glioblastoma is part of its push to test the potential
of immunotherpies in a broad range of cancers.
Gilbert said he has met with company officials, who still
need to give written approval for their drugs to be used in the
Initially, the trial in newly diagnosed patients will test
the safety of the drugs in some 42 patients, Gilbert said. One
concern is that bolstering the immune system in the brain could
trigger an autoimmune reaction known as encephalitis, causing
swelling and worsening patients' symptoms.
But so far, the studies in patients with recurrent tumors
have not shown that to be a major issue, Gilbert said.
"We have to take it slow. We want to understand what we're
doing," he said.
What is challenging about brain tumors is getting active
treatments through a protective membrane called the blood-brain
barrier. A major study led by Gilbert, reported at last year's
American Society of Clinical Oncology meeting, showed Roche's
antibody drug Avastin failed to prolong life in
patients with newly diagnosed disease.
But early studies of immunotherapy in melanoma showed the
treatments did shrink tumors in patients whose cancer has spread
to the brain, suggesting that immune system cells were reaching
their target in the brain and raising hope for immunotherapy
Gilbert acknowledged that research on brain tumors has
lagged some other fields, especially with new immune system
therapies, but he sees that changing.
Glioblastomas are the most common and most deadly form of
brain and nervous system tumors, which affect an estimated
240,000 adults globally per year. With standard treatments,
average survival is 15 to 17 months.
(Reporting by Julie Steenhuysen; Editing by Tom Brown)