Results from KEYNOTE-024, which Studied
KEYTRUDA Compared to Chemotherapy in Patients with High Levels of
PD-L1 Expression, and KEYNOTE-021G, which Studied KEYTRUDA in
Combination with Chemotherapy Compared to Chemotherapy Alone in
Patients Regardless of PD-L1 Expression, to be Presented
Comprehensive Data from Merck’s
Industry-Leading Immuno-Oncology Clinical Development Program to be
Presented, with New Data in 12 Cancers
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that extensive data on KEYTRUDA®
(pembrolizumab), the company’s anti-PD-1 therapy, have been
accepted for presentation at the European Society for Medical
Oncology (ESMO) 2016 Congress in Copenhagen, Denmark, Oct. 7 – 11.
In total, findings from 30 studies in 12 cancers from Merck’s
industry-leading clinical development program for KEYTRUDA – both
as monotherapy and in combination – will be presented at this
year’s ESMO. Two studies of KEYTRUDA in first-line treatment of
advanced lung cancer have also been selected for presentation at
the Presidential Symposium on Oct. 9: KEYNOTE-024, which studied
KEYTRUDA as monotherapy compared to chemotherapy in patients whose
tumors express high levels of PD-L1 (tumor proportion score of 50
percent or more), and KEYNOTE-021G, which studied KEYTRUDA plus
chemotherapy (carboplatin and pemetrexed) compared to chemotherapy
alone in all patients with non-squamous non-small cell lung cancer
(NSCLC).
KEYTRUDA-Related Data at the ESMO 2016 Congress
A select listing of the KEYTRUDA late-breaking and oral abstract
sessions at ESMO 2016 is included below:
Advanced Non-Small Cell Lung Cancer (NSCLC)
At ESMO, in addition to KEYNOTE-024 and KEYNOTE-021G, which
studied KEYTRUDA (pembrolizumab) in previously untreated patients
whose tumors were EGFR- and ALK-negative, updated overall survival
(OS) data from the phase 2/3 KEYNOTE-010 trial will be presented;
KEYNOTE-010 studied previously treated patients with advanced NSCLC
whose tumors express PD-L1 (tumor proportion score of one percent
or more).
Additional combination data will also be presented from the
phase 1b KEYNOTE-098 expansion cohort study investigating KEYTRUDA
in combination with the VEGF Receptor 2 antagonist, ramucirumab
(under the existing collaboration between Eli Lilly and Company and
Merck).
- (Abstract #LBA46_PR)
Presidential Symposium: Randomized, phase 2 study of carboplatin
and pemetrexed with or without pembrolizumab as first-line therapy
for advanced NSCLC: KEYNOTE-021 cohort G. C. Langer. Sunday,
October 9, 4:25 – 6:20 pm CEST. Location: Copenhagen.
- (Abstract #LBA8_PR) Presidential
Symposium: KEYNOTE-024: Pembrolizumab (pembro) vs platinum-based
chemotherapy (chemo) as first-line therapy for advanced NSCLC with
a PD-L1 tumor proportion score (TPS) ≥ 50%. M. Reck. Sunday,
October 9, 4:25 – 6:20 pm CEST. Location: Copenhagen.
- (Abstract #LBA48) Poster Discussion
Session: Pembrolizumab (pembro) vs docetaxel (doce) for previously
treated, PD-L1–expressing NSCLC: updated outcomes of
KEYNOTE-010. R. Herbst. Sunday, October 9, 2:45 – 4:15 pm CEST.
Location: Oslo.
- (Abstract #LBA38) Poster Discussion
Session: Interim safety and clinical activity in patients
with advanced NSCLC from a multi-cohort phase 1 study of
ramucirumab (R) plus pembrolizumab (P). R. Herbst. Monday,
October 10, 9:30 – 10:30 am CEST. Location: Berlin.
Advanced Bladder Cancer
At ESMO, data investigating the first-line use of KEYTRUDA in
patients with unresectable or advanced urothelial (bladder) cancer
will be presented from the phase 2 KEYNOTE-052 trial; results will
be featured in the official ESMO press program. This is the first
presentation of data investigating KEYTRUDA in the first-line
bladder cancer treatment setting.
- (Abstract #LBA32_PR) Proffered Paper
Session: Pembrolizumab (pembro) as first-line therapy for
advanced/unresectable or advanced urothelial cancer: Preliminary
results from the phase 2 KEYNOTE-052 study. A. Balar. Saturday,
October 8, 9:15 – 10:30 am CEST. Location: Madrid.
Advanced Melanoma
At ESMO, final OS data from the phase 2 KEYNOTE-002 trial
investigating
KEYTRUDA (pembrolizumab) monotherapy compared to chemotherapy in
patients with ipilimumab-refractory advanced melanoma will be
presented.
- (Abstract #1107O) Proffered Paper
Session: Final overall survival for KEYNOTE-002: pembrolizumab
(pembro) versus investigator-choice chemotherapy (chemo) for
ipilimumab (ipi)-refractory melanoma. O. Hamid. Saturday,
October 8, 2:45 – 4:15 pm CEST. Location: Copenhagen.
Additional Data from Merck’s Oncology Portfolio and
Pipeline
Data investigating the use of two compounds from Merck’s
oncology pipeline and portfolio – EMEND® (fosaprepitant
dimeglumine), a substance P/neurokinin-1 (NK1) receptor antagonist,
and MK-2206, an investigational AKT inhibitor – were also accepted
for presentation at this year’s ESMO. For more information,
including a complete list of abstract titles, please visit the ESMO
website at
https://cslide.ctimeetingtech.com/library/esmo/browse/itinerary/5286.
About KEYTRUDA® (pembrolizumab)
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 administered as an intravenous infusion over 30
minutes every three weeks for the approved indications. KEYTRUDA
for injection is supplied in a 100 mg single use vial.
KEYTRUDA Indications and Dosing
Melanoma
KEYTRUDA is indicated for the treatment of patients with
unresectable or metastatic melanoma at a dose of 2 mg/kg every
three weeks.
Lung Cancer
KEYTRUDA (pembrolizumab) is 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,
at a dose of 2 mg/kg every three weeks. Patients with EGFR or ALK
genomic tumor aberrations should have disease progression on
FDA-approved therapy for these aberrations prior to receiving
KEYTRUDA. This 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.
Head and Neck Cancer
KEYTRUDA is indicated for the treatment of patients with
recurrent or metastatic head and neck squamous cell carcinoma
(HNSCC) with disease progression on or after platinum-containing
chemotherapy at a fixed dose of 200 mg every three weeks. This
indication is approved under accelerated approval based on tumor
response rate and durability of response. Continued approval for
this indication may be contingent upon verification and description
of clinical benefit in the confirmatory trials.
Selected Important Safety Information for
KEYTRUDA® (pembrolizumab)
Immune-mediated pneumonitis, including fatal cases, occurred in
patients receiving KEYTRUDA. Pneumonitis occurred in 32 (2.0%) of
1567 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 NSCLC, including Grade 2 (1.1%), 3 (1.3%), 4 (0.4%),
or 5 (0.2%) pneumonitis and more frequently in patients with a
history of asthma/chronic obstructive pulmonary disease (5.4%) or
prior thoracic radiation (6.0%). 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 1567 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
(pembrolizumab) for Grade 2 or 3; permanently discontinue KEYTRUDA
for Grade 4 colitis.
Immune-mediated hepatitis occurred in patients receiving
KEYTRUDA. Hepatitis occurred in 16 (1%) of 1567 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 1567 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 1567 patients with
melanoma, including Grade 2 (0.6%) and 3 (0.1%) hyperthyroidism.
Hypothyroidism occurred in 127 (8.1%) of 1567 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. New or worsening hypothyroidism occurred in
28 (14.6%) of 192 patients with HNSCC, including Grade 3 (0.5%)
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 for
Grade 3 or 4 hyperthyroidism.
Type 1 diabetes mellitus, including diabetic ketoacidosis,
occurred in 3 (0.1%) of 2117 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 patients receiving
KEYTRUDA. Nephritis occurred in 7 (0.4%) of 1567 patients with
melanoma including, Grade 2 (0.2%), 3 (0.2%), and 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 (pembrolizumab) 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 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 2117 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.
In KEYNOTE-006, 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 with KEYTRUDA vs ipilimumab were fatigue
(28% vs 28%), diarrhea (26% with KEYTRUDA), rash (24% vs 23%), 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
(pembrolizumab).
In KEYNOTE-002, 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 maculopapular rash (1%). The most common
adverse reactions with KEYTRUDA vs chemotherapy were fatigue (43%
with KEYTRUDA), pruritus (28% vs 8%), rash (24% vs 8%),
constipation (22% vs 20%), nausea (22% with KEYTRUDA), diarrhea
(20% vs 20%), 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
at least 2% 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%), cough (29%), decreased appetite (25%), and dyspnea
(23%).
KEYTRUDA was discontinued due to adverse reactions in 17% of 192
patients with HNSCC. Serious adverse reactions occurred in 45% of
patients. The most frequent serious adverse reactions reported in
at least 2% of patients were pneumonia, dyspnea, confusional state,
vomiting, pleural effusion, and respiratory failure. The most
common adverse reactions (reported in at least 20% of patients)
were fatigue (46%), decreased appetite (22%), and dyspnea
(20%).
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.
As part of our focus on cancer, Merck is committed to exploring
the potential of immuno-oncology with one of the fastest-growing
development programs in the industry. We are currently executing an
expansive research program that includes more than 330 clinical
trials evaluating our anti-PD-1 therapy across more than 30 tumor
types. We also continue to strengthen our immuno-oncology portfolio
through strategic acquisitions and are prioritizing the development
of several promising immunotherapeutic candidates with the
potential to improve the treatment of advanced cancers.
For more information about our oncology clinical trials, visit
www.merck.com/clinicaltrials.
About Merck
For 125 years, Merck has been 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
litigation, including patent litigation, and/or regulatory
actions.
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 2015
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.
View source
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MerckMedia:Pamela Eisele, 267-305-3558Kim Hamilton,
908-740-1863orInvestors:Teri Loxam, 908-740-1986Amy Klug,
908-740-1898
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