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Merck’s Keytruda reduced risk of disease recurrence or death in early lung
cancer patients by 24%
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Merck’s Keytruda reduced risk of disease recurrence or death in early lung
cancer patients by 24%
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MERCK’S KEYTRUDA REDUCED RISK OF DISEASE RECURRENCE OR DEATH IN EARLY LUNG
CANCER PATIENTS BY 24%

Published Thu, Mar 17 20222:17 PM EDTUpdated Thu, Mar 17 20227:00 PM EDT
Spencer Kimball@spencekimball
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Key Points
 * Merck’s monoclonal antibody therapy Keytruda reduced the risk of early stage
   lung cancer returning or death by 24% in patients who had undergone surgery,
   according to clinical trial data.
 * The 200-milligram shots are administered once every three weeks for a total
   of 18 injections over the course of a year.
 * Keytruda helps activate the body’s immune system to fight cancer. It’s FDA
   approved as a therapy for numerous other cancer types.
 * Merck plans to submit the data on early stage lung cancer to the FDA as soon
   as possible.

In this article

 * MRK+0.17 (+0.22%)
   

Stefanie Joho, 27, stands for a portrait at the home of a friend in Penn Valley,
PA on Tuesday, May 9, 2017. Joho, who was diagnosed with colon cancer at 22
years old, has been in remission since February 2016, thanks to an immunotherapy
drug targeted at specific mutations that prevents repair of DNA-replication
mistakes. The FDA is expected to decide approval of the drug, Merck’s Keytruda,
by mid May.
Michelle Gustafson | The Washington Post | Getty Images

Merck’s antibody therapy for early stage lung cancer patients who have
previously undergone surgery to have tumors removed reduced the risk of the
disease returning again or the patient dying by 24%, according to clinical trial
data released Thursday.

Keytruda is a monoclonal antibody treatment that helps activate the body’s
immune system to fight off non-small cell lung cancer, the most common form of
the disease. The 200-milligram shots are administered once every three weeks for
a total of 18 injections over the course of a year.



Merck’s head of global clinical development, Dr. Roy Baynes, described the
reduced risk of the cancer returning as significant and clinically meaningful.
Baynes also expects Keytruda to improve patients’ overall survival rate, though
he said the data is not mature enough yet to draw a definitive conclusion in
that regard.

“When you treat a tumor early, it takes quite a long time for bad outcomes to
translate into death,” Baynes said. “So the trial is too immature at this point
to comment on overall survival, although we would say that the overall survival
is directionally favorable at this time.”

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The clinical trial for early stage lung cancer patients post-surgery evaluated
more than 1,000 people randomized into two groups, 590 who received the
treatment and 587 who received a placebo. Patients who received Keytruda were
disease for more than four years at the median, about a year longer than those
in the placebo group. The trial included patients who received chemotherapy and
those who hadn’t.

Merck plans to submit the data to the Food and Drug Administration as quickly as
possible, spokesperson Melissa Moody said. The approval process can take eight
to 12 months, according to Baynes. Keytruda was first approved by the FDA in
2014 to treat melanoma and has become a blockbuster drug for Merck that is now
used to treat numerous other types of cancer.

Baynes said significant progress has been made in treating lung cancer with
immune therapy. He noted that in the case of metastatic lung cancer, where the
disease has advanced to other areas of the body, Keytruda in combination with
chemo has improved the five-year survival rate to 40%. Typically, the survival
rate is only 5%.



Lung cancer is the leading cause of cancer death globally with more than 1.7
million people succumbing to the disease in 2020, according to the World Health
Organization. People diagnosed with non-small cell lung cancer normally undergo
surgery to remove the tumors if the disease is caught at an early stage. After
surgery, patients undergo either observation or receive chemotherapy. Risk
factors include a history of smoking and asbestos exposure among others.


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However, half of all patients with early stage non-small cell lung cancer have
the disease return within five years after removing the tumors and most of them
see the cancer return in two years, according to Dr. Mary O’Brien, a
co-principal investigator in the trial and an oncologist at Royal Marsden
Hospital in London. Patients live with the constant fear and anxiety that the
cancer will return, she said.

Keytruda stops cancer cells from shutting down the body’s defense system. Cancer
cells have a protein that binds to a receptor on T cells, which tricks them into
not going on the attack. The Keytruda monoclonal antibody binds to this receptor
instead, foiling the cancer’s trick and allowing the immune system to fight the
disease.

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Baynes said the drug is generally well tolerated, though there are side effects
associated with the immune system kicking into gear. The most common
complication is thyroid toxicity, which occurs when the thyroid releases too
much hormone into the body. In more serious but rare cases, patients can develop
pneumonitis, an inflammation of the lung tissue, he said. Thyroid toxicity is
treated with antithyroid medication and pneumonitis with steroids.

Merck’s Keytruda sales totaled $17.2 billion in 2021 or about 35% of the
company’s $48.7 billion in total revenue for the year. CEO Rob Davis told
investors on Merck’s fourth-quarter earnings call that using Keytruda to prevent
cancer from returning in patients is a major area of future growth for the
company.

While the cancer immune therapy is a major area of clinical research, the FDA
has only approved one treatment so far to prevent lung cancer from returning in
patents who have undergone surgery. The agency approved Tecentriq, made by
Genentech, last October.


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