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 Dr. Richard Pazdur, head of the Food and Drug Administration's
office of oncology products, was referring to therapies designed to
disable the PD-1 protein that tumors use to evade the immune system.
The FDA has approved such treatments from Merck & Co, Bristol-Myers
Squibb Co and Roche Holding AG, each of which have list prices of
$150,000 per year. At least five other drugmakers are developing
similar medicines.
"People should ask themselves ... would we be better off spending
those resources into looking at more novel drugs?" Pazdur told
Reuters during the annual American Society of Clinical Oncology (ASCO)
meeting in Chicago this week.
Pazdur acknowledged that the success of a few drugmakers in the
worldwide $110 billion market for cancer treatments makes it
attractive for rivals to continue developing similar therapies
rather than invest heavily in unproven approaches.
"As with everything in drug development, it is about reduction of
risk," he said. But the number of similar drugs in development at
the same time is a first in the oncology field, and latecomers to
the PD-1 market will likely be relegated to "niche" indications, he
added.
Drug company executives disputed Pazdur's critique. In interviews
with Reuters, they argued that the science around cancer is
advancing rapidly, with a focus on how to best combine therapies to
attack multiple mechanisms of the disease, determine which patients
are most likely to respond to them and how long patients will need
to be treated.
Bristol-Myers and Merck are widely viewed as leaders in the
immunotherapy race, with treatments defying the odds to help
patients fight off some of the deadliest cancers. Merck's Keytruda
was shown to help a significant number of patients with advanced
melanoma live at least three years, while Bristol-Myers' Opdivo
prolonged life for some lung cancer patients by two years, according
to data presented at the ASCO meeting.
In practice, doctors say, around 20 percent of advanced cancer
patients respond to the new drugs and a subset of those patients can
have lasting remissions.
AstraZeneca PLC's PD-1 received "breakthrough" status from the FDA
to expedite review for treating a type of bladder cancer. Other
companies in earlier stages of development include Pfizer Inc, in
partnership with Germany's Merck KGaA, Novartis AG, Regeneron
Pharmaceuticals Inc and China's BeiGene.
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"Our reason to go into PD-1s is not just to have a 'me too' drug,"
said Israel Lowy, head of translational science and oncology at
Regeneron, which has a PD-1 in early-stage trials. "Most people
think that the future is in combinations ... Having our own PD-1
that is active and useful gives us enormous flexibility in how we do
clinical trials." ENOUGH PROFIT FOR EVERYONE? Industry executives
say they are investing in additional, potentially complementary,
approaches to PD-1 treatment that can eventually be used against
many types and stages of cancer. "We don't look at ourselves as
'latecomers.' We are leading in multiple areas with combination
therapies," said Bahija Jallal, executive vice president at
AstraZeneca's MedImmune unit, which is testing its PD-1 candidate
with a range of other experimental drugs. "The question is, how can
we really follow the science," Jallal said. At the ASCO meeting, for
example, Pfizer presented early-stage data from a trial showing that
its experimental agent 4-1BB, which aims to increase T-cells, was
safe when combined with Merck's Keytruda, but only two of 23
patients achieved complete remissions for a year.
"Somebody may emerge with a surprise new mechanism," said Leerink
Partners pharmaceutical analyst Seamus Fernandez. He said drugs from
Bristol-Myers and Merck will most likely become the standard of care
for many patients. Pazdur and other experts agreed that the biggest
opportunity for cancer immunotherapies will be their use earlier on
in treatment. Fernandez said Bristol-Myers could "win the war," if
it succeeds with a combination of Opdivo and its other immunotherapy
Yervoy as an initial treatment for advanced non-small cell lung
cancer. Merck and Roche are testing their PD-1s combined with
chemotherapy for the same purpose. In the end, patients may benefit
from lower costs if Merck and Bristol-Myers face more rivals in the
marketplace. Both Keytruda and Opdivo have a U.S. list price of
about $150,000 per year.
If combinations of expensive therapies become the norm, drugmakers
could theoretically keep prices lower by mixing their own treatments
rather than seeking permission from a rival. "The profits on
oncology drugs are so high that 'me-too' drugs will be developed,"
said Joel Hay, professor of pharmaceutical economics and policy at
the University of Southern California. "They will ultimately reduce
the profits in that class. That's how competition is supposed to
work."
(Reporting By Deena Beasley; Editing by Michele Gershberg and David
Gregorio)
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