Bristol, Merck, Roche immune therapies
are cancer meeting focus
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[May 15, 2014]
By Bill Berkrot
(Reuters) — When
the world's leading cancer doctors meet in Chicago next month, new
treatments from Merck & Co, Bristol-Myers Squibb Co and Roche Holding AG
that help the immune system fight disease are expected to capture much
of the spotlight.
The drugs, known as anti-PD-1 or anti-PDL1
therapies, are biotech medicines that work by blocking a tumor's
ability to camouflage itself, thereby allowing T cells in the immune
system to recognize and attack the cancer.
They have shown great promise against advanced melanoma - the
deadliest of skin cancers - as well as advanced lung and kidney
cancers, with relatively mild side effects, generating excitement
among researchers and investors.
At the American Society of Clinical Oncology meeting in Chicago
beginning May 30, researchers will for the first time present data
on Roche's anti-PDL1 drug in advanced bladder cancer for which there
have been few advances in decades.
Merck will have no less than 16 studies involving its highly touted
anti PD-1 drug, MK-3475, including a first look at the drug as an
initial lung cancer treatment. Early data released on Wednesday
showed 36 percent of 45 patients had an initial immune response to
the treatment. Merck will also provide results from the first trial
of the drug in head and neck cancer.
Brief summaries, or abstracts, of thousands of studies to be
presented at the ASCO meeting were released on Wednesday.
"This area should represent a major advance in cancer therapy and
patient survivability," said Len Yaffe, portfolio manager for the
healthcare fund StockDoc Partners. "Wall Street is increasingly
recognizing the multibillion-dollar potential for cancer
The potential for lasting effects of these drugs will be on display
in a pair of studies involving the Bristol-Myers anti PD-1 drug
Researchers will present follow-up data from a 107-patient nivolumab
study in metastatic melanoma showing that 41 percent were still
alive after three years, an apparent leveling off from the 48
percent survival rate after two years.
Three-year survival with advanced melanoma was virtually unheard of
prior to the advent of cancer immunotherapy.
In a trial of patients whose advanced kidney cancer had progressed
following prior treatments, the mean overall survival was 25.5
months for the 2 milligram nivolumab dose.
Past kidney cancer studies of drugs currently in use have
demonstrated a mean survival of about 14 months, said Fouad Namouni,
Bristol's head of global development for nivolumab.
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MOST LIKELY TO BENEFIT
As drugmakers face greater scrutiny over how they price new
therapies - with immuno-oncology expected to be among the most
expensive - several studies will aim to identify which patients are
most likely to benefit from the new treatments.
Researchers can now perform a test to determine the degree to which
the PD-L1 protein is expressed on the surface of cancer cells. On a
0 to 3 scale, a score of 0 or 1 is considered PD-L1 negative, while
2 or 3 is deemed PD-L1 positive.
If early data is confirmed in larger trials, this class of
immunotherapies could become standalone treatments for some
patients, while PD-L1 negative patients may require combination or
alternative therapies, according to some researchers.
In a small, Phase I study of Bristol's nivolumab in previously
untreated patients with advanced lung cancer, five out of 10 PD-L1
positive patients saw their tumors shrink by at least 30 percent. No
such responses were seen among 7 PD-L1 negative patients. Roche also
saw half of the 20 PD-L1 positive patients in its bladder cancer
trial respond to its drug.
Namouni said Bristol would focus on PD-L1 positive patients only in
a large Phase III lung cancer trial of previously untreated
subjects. Its Phase III studies of those who had received prior
treatments will include PD-L1 negative patients.
(Reporting by Bill Berkrot; Editing by Michele Gershberg and Andre
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