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 Merck & Co showed that its Keytruda drug helped many patients with
advanced melanoma survive at least three years, while Bristol-Myers
demonstrated that Opdivo can prolong life for a significant number
of patients with advanced lung cancer by at least two years.
The results were released on Wednesday ahead of the American Society
of Clinical Oncology meeting in Chicago next month.
Keytruda and Opdivo are among the first wave of successful immuno-oncology
drugs with a list price of about $150,000 a year. They work by
blocking a protein called PD-1 that tumors use to evade detection by
the immune system.
In one study, researchers following 655 patients with advanced
melanoma reported 40 percent of those who received Keytruda were
still alive three years after beginning treatment.
Prior to the appearance of these new drugs, this deadliest form of
skin cancer had no effective treatments and most patients died less
than a year after the disease spread to other parts of the body.
"For 40 percent of these patients to be alive at three years is a
big deal," Dr. Daniel Hayes, a University of Michigan oncologist who
will take the role of ASCO president next month, said in an
interview. "It makes us wonder if we can use the word 'cure'" for
some patients.
Survival with Keytruda was similar regardless of whether patients
had previously been treated with an older immunotherapy called
Yervoy from Bristol-Myers. Among newly-diagnosed patients who had
not received any prior treatment, 45 percent were still alive after
three years.
In a separate study testing Keytruda against Yervoy in advanced
melanoma, 55 percent of those who received the Merck drug were alive
after two years versus 43 percent for Bristol's Yervoy.
"These are previously unattainable results, but could represent the
new normal," said Dr. Roger Dansey, who oversees late-stage oncology
drug development for Merck.
Data was made available through abstracts, or brief descriptions, of
the studies to be formally presented at the ASCO meeting.
In a pair of lung cancer studies, Bristol's Opdivo kept far more
patients alive at least two years after beginning treatment compared
with those who received chemotherapy.
One Opdivo study involved 272 patients with the squamous form of
non-small cell lung cancer (NSCLC) that had progressed after prior
chemotherapy treatment.
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Twenty-three percent of those who received Opdivo were alive two
years after beginning therapy versus 8 percent of those treated with
the standard chemotherapy docetaxel.
For those alive after two years, there was no evidence that the
Opdivo benefit had begun to wane, Bristol-Myers said.
"We're really beginning to deliver now on the promise of immuno-oncology,
which is to provide as many patients as possible with the potential
for survival benefit," said Nick Botwood, development chief for lung
and head and neck cancers at Bristol-Myers. "There's a very clear
difference between Opdivo and the old standard of care, which is
chemotherapy."
In a separate study of 582 patients with advanced non-squamous NSCLC,
29 percent of those treated with Opdivo following chemotherapy were
alive after two years versus 16 percent for docetaxel.
Both forms of NSCLC are associated with smoking and relatively
short-term survival. NSCLC accounts for more than 80 percent of lung
cancers.
The incidence of serious side effects in the two studies was much
lower for Opdivo than chemotherapy, the company said.
"With long-term follow-up, we're not seeing any increase in Opdivo
related side effects," Botwood said.
Opdivo and Keytruda, both injectable biotech drugs, are fast
becoming the second-line standard of care for NSCLC after
chemotherapy, as well as the treatment of choice for melanoma that
has spread.
They are also being tested against a wide variety of cancers, and in
combinations with many drugs, including other immunotherapies and
other types of cancer medicines.
(Reporting by Bill Berkrot; Editing by Michele Gershberg and Nick
Zieminski)
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