Seven Registration-Enabling Trials
Evaluating KEYTRUDA in Patients with Gastrointestinal Cancers are
Planned or Underway
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, announced today that new and updated findings investigating
the use of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1
therapy, in multiple gastrointestinal cancers will be presented at
this year’s Gastrointestinal (GI) Cancers Symposium in San
Francisco, Jan. 21 – 23. Updates on pembrolizumab include data on
advanced esophageal carcinoma and new preliminary Phase 2 safety
data in gastric cancer.
“Advanced gastrointestinal cancers are difficult to treat and
new therapies are needed,” said Roger Dansey, M.D., senior vice
president and therapeutic area head, oncology late-stage
development, Merck Research Laboratories. “Through our rapidly
advancing clinical program, we have seen promising results with
KEYTRUDA in several gastrointestinal cancers, and are hopeful about
the potential of KEYTRUDA for these patients.”
The KEYTRUDA clinical trials program currently includes more
than 30 tumor types in more than 200 clinical trials, including
more than 80 trials that combine KEYTRUDA with other cancer
treatments. More than 20 of these trials are evaluating KEYTRUDA in
gastrointestinal cancers, including seven registration-enabling
studies in gastric cancer, colorectal cancer and esophageal cancer.
Registration-enabling trials of KEYTRUDA are also currently
enrolling patients with melanoma, non-small cell lung cancer, head
and neck cancer, bladder cancer, Hodgkin lymphoma, multiple
myeloma, and breast cancer, and further trials are being planned
for other malignancies.
Merck’s Immuno-Oncology Data at the 2016 GI Cancers
Symposium
A full listing of KEYTRUDA abstracts for both oral and poster
sessions is below:
Oral Presentations
- (Abstract #7) Updated results
for the advanced esophageal carcinoma cohort of the phase 1b
KEYNOTE-028 study of pembrolizumab (MK-3475). T. Doi. Poster
Presentation: Thursday, Jan. 21, 12:30 – 2:00 p.m. and 5:30 – 7:00
p.m. PST. Oral Presentation: Thursday, Jan. 21, 2:00 – 3:30 p.m.
PST. Location: Moscone West Building.
- (Abstract #195) PD-1 blockade
in mismatch repair deficient non-colorectal gastrointestinal
cancers. D. Le. Poster Presentation: Friday, Jan. 22, 12:30 –
2:00 p.m. and 5:30 – 7:00 p.m. PST. Oral Presentation: Friday, Jan.
22, 2:00 – 3:30 p.m. PST. Location: Moscone West Building.
Poster Presentations
- (Abstract #TPS161)
Pembrolizumab (MK-3475) plus 5-fluorouracil (5-FU) and cisplatin
for first-line treatment of advanced gastric cancer: Preliminary
safety data from KEYNOTE-059. C. Fuchs. Thursday, Jan. 21,
12:30 – 2:00 p.m. and 5:30 – 7:00 p.m. PST. Location: Moscone West
Building.
- (Abstract #TPS183)
Pembrolizumab (MK-3475) versus paclitaxel as second-line therapy
for advanced gastric or gastroesophageal junction (GEJ)
adenocarcinoma: Phase 3 KEYNOTE-061 study. A. Ohtsu. Thursday,
Jan. 21, 12:30 – 2:00 p.m. and 5:30 – 7:00 p.m. PST. Location:
Moscone West Building.
- (Abstract #TPS184)
Pembrolizumab (MK-3475) for recurrent or metastatic gastric or
gastroesophageal junction (GEJ) adenocarcinoma: Multicohort phase
II KEYNOTE-059 study. C. Fuchs. Thursday, Jan. 21, 12:30 – 2:00
p.m. and 5:30 – 7:00 p.m. PST. Location: Moscone West
Building.
- (Abstract #TPS185)
KEYNOTE-062: Phase III study of pembrolizumab (MK-3475) alone or
in combination with chemotherapy versus chemotherapy alone as
first-line therapy for advanced gastric or gastroesophageal
junction (GEJ) adenocarcinoma. J. Tabernero. Thursday, Jan. 21,
12:30 – 2:00 p.m. and 5:30 – 7:00 p.m. PST. Location: Moscone West
Building.
- (Abstract #TPS189)
Pembrolizumab (MK-3475) for previously treated metastatic
adenocarcinoma or squamous cell carcinoma of the esophagus: Phase
II KEYNOTE-180 study. M. Shah. Thursday, Jan. 21, 12:30 – 2:00
p.m. and 5:30 – 7:00 p.m. PST. Location: Moscone West
Building.
- (Abstract #465) Phase 1/2a
study of double immune suppression blockade by combining a CSF1R
inhibitor (pexidartinib/PLX3397) with an anti PD-1 antibody
(pembrolizumab) to treat advanced melanoma and other solid
tumors. Z. Wainberg. Friday, Jan. 22, 12:30 – 2:00 p.m. and
5:30 – 7:00 p.m. PST. Location: Moscone West Building.
- (Abstract #TPS787)
KEYNOTE-164: Phase II study of pembrolizumab (MK-3475) for
patients with previously treated, microsatellite instability-high
advanced colorectal carcinoma. D. Le. Saturday, Jan. 23, 7:00 –
7:55 a.m. and 12:30 – 2:00 p.m. PST. Location: Moscone West
Building.
- (Abstract #TPS789)
KEYNOTE-177: First-line, open-label, randomized, phase 3 study
of pembrolizumab (MK-3475) versus investigator-choice chemotherapy
for mismatch repair deficient or microsatellite instability-high
metastatic colorectal carcinoma. L Diaz. Saturday, Jan. 23,
7:00 – 7:55 a.m. and 12:30 – 2:00 p.m. PST. Location: Moscone West
Building.
About Gastrointestinal Cancer
Gastrointestinal cancer is a term for a group of cancers that
affect the digestive system, including cancers of the esophagus,
gallbladder, liver, pancreas, stomach, small intestine, colon,
rectum, and anus. Cancer of the colon or rectum, also called
colorectal cancer, is the third most common cancer in men and the
second most common cancer in women worldwide, accounting for more
than 600,000 cases each year. Esophageal cancer, a type of cancer
that begins in the inner layer of the esophagus, is the eighth most
common cancer worldwide with an estimated 456,000 new cases
diagnosed in 2012.
About KEYTRUDA® (pembrolizumab) Injection 100
mg
KEYTRUDA is a humanized monoclonal antibody that works by
increasing the ability of the body’s immune system to help detect
and fight tumor cells. KEYTRUDA blocks the interaction between PD-1
and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes
which may affect both tumor cells and healthy cells.
KEYTRUDA is indicated in the United States for the treatment of
patients with unresectable or metastatic melanoma.
KEYTRUDA is also indicated for the treatment of patients with
metastatic non-small cell lung cancer (NSCLC) whose tumors express
PD-L1 as determined by an FDA-approved test with disease
progression on or after platinum-containing chemotherapy. Patients
with EGFR or ALK genomic tumor aberrations should have disease
progression on FDA-approved therapy for these aberrations prior to
receiving KEYTRUDA. The NSCLC indication is approved under
accelerated approval based on tumor response rate and durability of
response. An improvement in survival or disease-related symptoms
has not yet been established. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials.
KEYTRUDA is administered at a dose of 2 mg/kg as an intravenous
infusion over 30 minutes every three weeks for the approved
indications.
Selected Important Safety Information for
KEYTRUDA® (pembrolizumab)
Immune-mediated pneumonitis, including fatal cases, occurred in
patients receiving KEYTRUDA. Pneumonitis occurred in 32 (2%) of
1,567 patients with melanoma, including Grade 1 (0.8%), 2 (0.8%),
and 3 (0.4%) pneumonitis. Pneumonitis occurred in 19 (3.5%) of 550
patients with non-small cell lung cancer (NSCLC), including Grade 2
(1.1%), 3 (1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis. Monitor
patients for signs and symptoms of pneumonitis. Evaluate suspected
pneumonitis with radiographic imaging. Administer corticosteroids
for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2;
permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent
Grade 2 pneumonitis.
Immune-mediated colitis occurred in 31 (2%) of 1,567 patients
with melanoma, including Grade 2 (0.5%), 3 (1.1%), and 4 (0.1%)
colitis. Immune-mediated colitis occurred in 4 (0.7%) of 550
patients with NSCLC, including Grade 2 (0.2%) or 3 (0.4%) colitis.
Monitor patients for signs and symptoms of colitis. Administer
corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA
for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4
colitis.
Immune-mediated hepatitis occurred in 16 (1%) of 1,567 patients
with melanoma, including Grade 2 (0.1%), 3 (0.7%), and 4 (0.1%)
hepatitis. Monitor patients for changes in liver function.
Administer corticosteroids for Grade 2 or greater hepatitis and,
based on severity of liver enzyme elevations, withhold or
discontinue KEYTRUDA.
Hypophysitis occurred in 13 (0.8%) of 1,567 patients with
melanoma, including Grade 2 (0.3%), 3 (0.3%), and 4 (0.1%)
hypophysitis. Hypophysitis occurred in 1 (0.2%) of 550 patients
with NSCLC, which was Grade 3 in severity. Monitor patients for
signs and symptoms of hypophysitis (including hypopituitarism and
adrenal insufficiency). Administer corticosteroids and hormone
replacement as clinically indicated. Withhold KEYTRUDA for Grade 2;
withhold or discontinue for Grade 3 or 4 hypophysitis.
Hyperthyroidism occurred in 51 (3.3%) of 1,567 patients with
melanoma, including Grade 2 (0.6%) and 3 (0.1%) hyperthyroidism.
Hypothyroidism occurred in 127 (8.1%) of 1,567 patients with
melanoma, including Grade 3 (0.1%) hypothyroidism. Hyperthyroidism
occurred in 10 (1.8%) of 550 patients with NSCLC, including Grade 2
(0.7%) or 3 (0.3%) hyperthyroidism. Hypothyroidism occurred in 38
(6.9%) of 550 patients with NSCLC, including Grade 2 (5.5%) or 3
(0.2%) hypothyroidism. Thyroid disorders can occur at any time
during treatment. Monitor patients for changes in thyroid function
(at the start of treatment, periodically during treatment, and as
indicated based on clinical evaluation) and for clinical signs and
symptoms of thyroid disorders. Administer replacement hormones for
hypothyroidism and manage hyperthyroidism with thionamides and
beta-blockers as appropriate. Withhold or discontinue KEYTRUDA
(pembrolizumab) for Grade 3 or 4 hyperthyroidism.
Type 1 diabetes mellitus, including diabetic ketoacidosis,
occurred in 3 (0.1%) of 2,117 patients. Monitor patients for
hyperglycemia or other signs and symptoms of diabetes. Administer
insulin for type 1 diabetes, and withhold KEYTRUDA and administer
anti-hyperglycemics in patients with severe hyperglycemia.
Immune-mediated nephritis occurred in 7 (0.4%) of 1,567 patients
with melanoma, including Grade 2 (0.2%), 3 (0.2%) and Grade 4
(0.1%) nephritis. Monitor patients for changes in renal function.
Administer corticosteroids for Grade 2 or greater nephritis.
Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for
Grade 3 or 4 nephritis.
Other clinically important immune-mediated adverse reactions can
occur. For suspected immune-mediated adverse reactions, ensure
adequate evaluation to confirm etiology or exclude other causes.
Based on the severity of the adverse reaction, withhold KEYTRUDA
and administer corticosteroids. Upon improvement to Grade 1 or
less, initiate corticosteroid taper and continue to taper over at
least 1 month. Based on limited data from clinical studies in
patients whose immune-related adverse reactions could not be
controlled with corticosteroid use, administration of other
systemic immunosuppressants can be considered. Resume KEYTRUDA when
the immune-mediated adverse reaction remains at Grade 1 or less
following corticosteroid taper. Permanently discontinue KEYTRUDA
for any Grade 3 immune-mediated adverse reaction that recurs and
for any life-threatening immune-mediated adverse reaction.
The following clinically significant, immune-mediated adverse
reactions occurred in less than 1% (unless otherwise indicated) of
1567 patients with melanoma: arthritis (1.6%), exfoliative
dermatitis, bullous pemphigoid, uveitis, myositis, Guillain-Barré
syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic
anemia, and partial seizures arising in a patient with inflammatory
foci in brain parenchyma. The following clinically significant,
immune-mediated adverse reactions occurred in less than 1% of 550
patients with NSCLC: rash, vasculitis, hemolytic anemia, serum
sickness, and myasthenia gravis.
Severe and life-threatening infusion-related reactions have been
reported in 3 (0.1%) of 2,117 patients. Monitor patients for signs
and symptoms of infusion related reactions including rigors,
chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia,
and fever. For Grade 3 or 4 reactions, stop infusion and
permanently discontinue KEYTRUDA.
Based on its mechanism of action, KEYTRUDA can cause fetal harm
when administered to a pregnant woman. If used during pregnancy, or
if the patient becomes pregnant during treatment, apprise the
patient of the potential hazard to a fetus. Advise females of
reproductive potential to use highly effective contraception during
treatment and for 4 months after the last dose of KEYTRUDA
(pembrolizumab).
In Trial 6, KEYTRUDA was discontinued due to adverse reactions
in 9% of 555 patients with advanced melanoma; adverse reactions
leading to discontinuation in more than one patient were colitis
(1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%),
polyneuropathy (0.4%), and cardiac failure (0.4%). Adverse
reactions leading to interruption of KEYTRUDA occurred in 21% of
patients; the most common (≥1%) was diarrhea (2.5%). The most
common adverse reactions were fatigue (28% with KEYTRUDA vs. 28%
with ipilimumab), diarrhea (26% with KEYTRUDA), rash (24% with
KEYTRUDA vs. 23% with ipilimumab), and nausea (21% with KEYTRUDA).
Corresponding incidence rates are listed for ipilimumab only for
those adverse reactions that occurred at the same or lower rate
than with KEYTRUDA.
In Trial 2, KEYTRUDA was discontinued due to adverse reactions
in 12% of 357 patients with advanced melanoma; the most common
(≥1%) were general physical health deterioration (1%), asthenia
(1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%).
Adverse reactions leading to interruption of KEYTRUDA occurred in
14% of patients; the most common (≥1%) were dyspnea (1%), diarrhea
(1%), and maculo-papular rash (1%). The most common adverse
reactions were fatigue (43% with KEYTRUDA), pruritus (28% with
KEYTRUDA vs. 8% with chemotherapy), rash (24% with KEYTRUDA vs. 8%
with chemotherapy), constipation (22% with KEYTRUDA vs. 20% with
chemotherapy), nausea (22% with KEYTRUDA), diarrhea (20% with
KEYTRUDA vs. 20% with chemotherapy), and decreased appetite (20%
with KEYTRUDA). Corresponding incidence rates are listed for
chemotherapy only for those adverse reactions that occurred at the
same or lower rate than with KEYTRUDA.
KEYTRUDA was discontinued due to adverse reactions in 14% of 550
patients with NSCLC. Serious adverse reactions occurred in 38% of
patients. The most frequent serious adverse reactions reported in
2% or more of patients were pleural effusion, pneumonia, dyspnea,
pulmonary embolism, and pneumonitis. The most common adverse
reactions (reported in at least 20% of patients) were fatigue
(44%), decreased appetite (25%), cough (29%), and dyspnea
(23%).
No formal pharmacokinetic drug interaction studies have been
conducted with KEYTRUDA.
It is not known whether KEYTRUDA is excreted in human milk.
Because many drugs are excreted in human milk, instruct women to
discontinue nursing during treatment with KEYTRUDA and for 4 months
after the final dose.
Safety and effectiveness of KEYTRUDA have not been established
in pediatric patients.
Our Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck
Oncology, helping people fight cancer is our passion and supporting
accessibility to our cancer medicines is our commitment. Our focus
is on pursuing research in immuno-oncology and we are accelerating
every step in the journey – from lab to clinic – to potentially
bring new hope to people with cancer. For more information about
our oncology clinical trials, visit
www.merck.com/clinicaltrials.
About Merck
Today's Merck is a global health care leader working to help the
world be well. Merck is known as MSD outside the United States and
Canada. Through our prescription medicines, vaccines, biologic
therapies and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access
to health care through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
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The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2014
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Please see Prescribing Information for KEYTRUDA
(pembrolizumab) at
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
and Patient Information/Medication Guide for KEYTRUDA at
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.
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