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 The yet-to-be-published studies involve drugs in a new class
designed to enable the body's immune system to fight cancer.
A recent trial of Merck's Keytruda showed that it worked better than
chemotherapy as an initial treatment for advanced non-small cell
lung cancer (NSCLC) in patients with high levels of a protein called
PDL1, believed to help identify those most likely to benefit from
this type of immunotherapy.
A separate trial of Bristol-Myers' Opdivo, which included patients
with much lower levels of the protein biomarker, did not show an
advantage over chemotherapy.
"It seems likely that PDL1, if these results hold, will be added to
the list of markers that someone needs prior to starting treatment,"
said Dr Edward Garon, a lung cancer specialist at the University of
California Los Angeles' Jonsson Comprehensive Cancer Center.
He said patients shown to have high levels of PDL1 will be started
on the Merck drug, while those who test negative may continue to be
treated with Opdivo.
Since Opdivo received regulatory approval for use without requiring
patients to be tested for PDL1 and clinicians were unfamiliar with
testing for the protein, doctors had favored use of the Bristol
drug, Garon said.
That preference has played out in sales. Opdivo's second-quarter
sales were $840 million, more than double those of Keytruda. Both
drugs have U.S. prices of nearly $150,000 a year.
"I do think that more oncologists may start choosing Keytruda," Dr
Trevor Bivona, assistant professor of medicine and member of the
University of California San Francisco's Helen Diller Family
Comprehensive Cancer Center, said in an emailed statement.
Both drugs were approved by U.S. regulators last year for previously
treated patients with advanced non-small cell lung cancer (NSCLC),
the most common form of the disease, but have not yet been approved
as initial lung cancer treatments.
Dr Barbara Gitlitz, a lung cancer specialist and associate professor
of clinical medicine at the University of Southern California, said
she would now choose Keytruda for advanced lung cancer patients with
high levels of PDL1 who were not in a clinical trial.
A survey of 79 U.S. and European oncologists, published last week by
investment services firm AllianceBernstein, found that 57 percent of
respondents anticipated using more Keytruda as a result of the
latest trial results, and 70 percent said they will be more likely
to order PDL1 testing for patients.
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Bristol-Myers earlier this month said its trial failed to show that
Opdivo worked better than chemotherapy for previously untreated
patients with advanced NSCLC. The trial included patients with
tumors testing 5 percent or higher for PDL1.
In June, Merck said trial data showed that Keytruda worked better
than chemo as an initial treatment for advanced NSCLC patients with
PDL1 levels of at least 50 percent.
FULL RESULTS TO COME
The Merck and Bristol-Myers trial results were summarized in press
releases but complete results have not been presented.
Full results could include a breakdown of how Opdivo fared in
patients with high levels of PDL1, but investors have already
shifted their bets. Shares of Bristol-Myers have fallen more than 20
percent since the latest trial results were announced, while shares
of Merck rose nearly 10 percent over the same period.
Besides Bristol and Merck, companies including Roche Holding AG and
AstraZeneca PLC are developing immune-system boosting drugs for
treating lung cancer. Clinicians and investors are awaiting more
trial data, including a range of studies examining combinations of
these drugs. Lung cancer, the leading cause of cancer deaths
worldwide, kills an estimated 1.6 million people each year,
according to the World Health Organization.
(Reporting By Deena Beasley; Editing by Cynthia Osterman)
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