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 Results from key clinical trials will be presented starting Friday
in Chicago at the annual meeting of the American Society of Clinical
Oncology. These will include studies aimed at defining ahead of time
which patients are likely to benefit from the costly drugs.
At the forefront will be rival drugs from Bristol-Myers Squibb Co
and Merck and Co designed to block a protein known as Programmed
Death receptor (PD-1) that is used by tumors to evade the body's
natural defenses.
"It's going to be an important meeting to get some more (details) on
the PD-1 and PD-L1 drugs," said Morningstar analyst Damien Conover.
Bristol's Opdivo, or nivolumab, was approved by the U.S. Food and
Drug Administration in December to treat advanced melanoma. In
March, it also received clearance to treat a form of lung cancer,
giving Bristol an early advantage in the much larger market. Merck's
Keytruda, or pembrolizumab, has been approved for advanced melanoma
since September and is awaiting regulatory approval in lung cancer
treatment.
First-quarter sales of both drugs surprised Wall Street, with
Keytruda sales reaching $83 million, compared to $40 million for
Opdivo, suggesting an early advantage for Merck in what many expect
will be a years-long battle for market share.
Other drugmakers working on similar treatments include Roche Holding
AG, AstraZeneca Plc and Pfizer Inc.
Many industry experts expect the entire class will eventually
generate billions of dollars in annual sales, particularly if proven
effective against other forms of cancer.
On Friday, the ASCO conference will feature studies looking at
Opdivo’s use against advanced liver cancer and non-squamous,
non-small cell lung cancer (NSCLC), the most common form of lung
cancer. Results will also be presented from a trial of Keytruda in
head and neck cancer.
"Bristol's in a really good position," said Leerink Partners analyst
Seamus Fernandez. "My expectation is that they're going to be and
will continue to be the leader in the lung cancer space." Lung
cancer, the most common cancer worldwide, is the largest cause of
cancer deaths in the United States.
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At the same time, he said, Merck may bolster its argument that
Keytruda has proven the broadest possible use to date, with "clear
activity in 13 different tumor types.”
Other data points that will be closely watched by oncologists and
investors include whether the level of PD-1 protein in a tumor can
predict how well the new immunotherapies will work. Earlier this
month, Roche said that a mid-stage trial of its experimental
immunotherapy, MPDL3280A, showed it doubled the likelihood of
survival for lung cancer patients with the highest levels PD-L1.
A separate trial of Merck's Keytruda to be released at ASCO was
designed to see whether a higher number of genetic mutations in a
tumor can lead to better results in treating colorectal and other
cancers.
Doctors at the meeting will also hear more on the potential for
combining different types of immunotherapies to make them more
effective, as well as the high costs associated with multiple
treatment regimens. Treatment with Opdivo or Keytruda alone in the
United States, for example, costs about $12,500 per month, or
$150,000 a year.
"Really the name of the game is having overall survival data in your
label," said Suntrust Robinson Humphrey analyst John Boris.
(Reporting by Deena Beasley in Los Angeles and Bill Berkrot in New
York; Editing by Diane Craft)
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