First Presentation of Patient-Reported
Outcomes from KEYNOTE-024 Study of Patients with Metastatic NSCLC
Whose Tumors Have High PD-L1 Expression (Tumor Proportion Score
[TPS] of 50 Percent or More)
Findings Presented in Plenary Session at
17th World Conference on Lung Cancer
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced positive health-related quality of life
(HRQoL) findings from an exploratory analysis from the phase 3
KEYNOTE-024 study investigating the use of KEYTRUDA®
(pembrolizumab), the company’s anti-PD-1 therapy, compared to
standard of care (SOC) platinum-containing chemotherapy for the
treatment of patients with metastatic non-small cell lung cancer
(NSCLC) whose tumors express high levels of PD-L1 (tumor proportion
score [TPS] of 50 percent or more). Specifically, patient-reported
outcomes showed clinically meaningful improvement with KEYTRUDA
compared to chemotherapy. Findings will be presented today at the
17th World Conference on Lung Cancer (WCLC) hosted by the
International Association for the Study of Lung Cancer.
“The patient-reported quality of life outcomes we are seeing in
the KEYNOTE-024 study are very encouraging and, coupled with
previously reported clinical data from this study, including a
survival benefit, are important in understanding the robust
clinical profile for KEYTRUDA compared to chemotherapy,” said Dr.
Roger Dansey, senior vice president and therapeutic area head,
oncology late-stage development, Merck Research Laboratories.
Dr. Julie Brahmer of the Johns Hopkins Kimmel Cancer Center will
present these findings as part of a plenary session at WCLC in
Vienna, Austria at 8:45 a.m. CET (Abstract #PL04a.01).
“For people living with lung cancer, who often face serious
health challenges brought on by the disease, quality of life is a
major concern when determining treatment and the data presented
today help us further understand the potential clinical benefit for
KEYTRUDA in these patients,” said Dr. Martin Reck, head of the
thoracic oncology department, LungenClinic Grosshansdorf,
Germany.
The KEYTRUDA (pembrolizumab) clinical development program
includes more than 30 tumor types in nearly 400 clinical trials,
including more than 200 trials that combine KEYTRUDA with other
cancer treatments. Merck has an expansive research program in NSCLC
and is currently advancing multiple registration-enabling studies
with KEYTRUDA as monotherapy and in combination with other
treatments.
Findings from KEYNOTE-024
KEYNOTE-024 is a randomized, open-label, phase 3 study
investigating KEYTRUDA monotherapy compared to SOC
platinum-containing chemotherapy for the first-line treatment of
patients with metastatic NSCLC. The study enrolled 305 patients who
had not received prior systemic chemotherapy for their metastatic
disease and whose tumors had high PD-L1 expression (TPS of 50
percent or more) with no EGFR or ALK aberrations. Patients were
randomized to receive a 200 mg fixed dose of KEYTRUDA every three
weeks (n=154) or four to six cycles of investigator’s choice
platinum-based chemotherapy (n=151). The primary outcome measure
was progression-free survival. Key secondary outcomes were overall
survival, overall response rate and safety; exploratory outcomes
were duration of response and patient-reported outcomes.
The HRQoL data presented at WCLC were based on change from
baseline to week 15 as assessed by two European Organization for
Research and Treatment of Cancer (EORTC) Core Quality of Life
Questionnaires measuring global health status (such as physical,
emotional, cognitive, and social functioning as well as fatigue and
pain) (QLQ-C30) and time to deterioration (measuring symptoms such
as cough, chest pain, alopecia, and dyspnea) (QLQ-LC13). Across
treatment arms, patient-reported outcome compliance was greater
than 90 percent at baseline and approximately 80 percent at week
15.
The findings showed that HRQoL and symptoms were improved or
maintained to a greater degree with KEYTRUDA compared to
chemotherapy (based on 299 patients who completed at least one
questionnaire). Specifically, the improvement in global health
status from baseline to week 15 (difference in least squares) for
KEYTRUDA was 6.9 (95% CI, 3.3-10.6) compared to -0.9 (95% CI,
-4.8-3.0) in the chemotherapy arm. Analysis based on specific
functioning and symptoms showed more patients treated with KEYTRUDA
(pembrolizumab) reporting an improvement in global health status
and/or quality of life, fatigue, and pain compared to patients
treated with chemotherapy. Fewer patients in the KEYTRUDA arm
experienced deterioration compared to chemotherapy (30.5% and
39.2%, respectively), with a prolonged time to deterioration also
observed in the KEYTRUDA arm (hazard ratio: 0.66 [95% CI,
0.44-0.97; p=0.029]).
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 until disease progression or unacceptable toxicity.
Lung Cancer
KEYTRUDA is indicated for the first-line treatment of patients
with metastatic non-small cell lung cancer (NSCLC) whose tumors
have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as
determined by an FDA-approved test, with no EGFR or ALK genomic
tumor aberrations.
KEYTRUDA is also indicated for the treatment of patients with
metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) 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.
In metastatic NSCLC, KEYTRUDA (pembrolizumab) is administered at
a fixed dose of 200 mg every three weeks until disease progression,
unacceptable toxicity, or up to 24 months in patients without
disease progression.
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. 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. In HNSCC, KEYTRUDA is administered at a fixed
dose of 200 mg every three weeks until disease progression,
unacceptable toxicity, or up to 24 months in patients without
disease progression.
Selected Important Safety Information for
KEYTRUDA® (pembrolizumab)
KEYTRUDA can cause immune-mediated pneumonitis, including fatal
cases. Pneumonitis occurred in 94 (3.4%) of 2799 patients receiving
KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%),
and 5 (0.1%) pneumonitis, and occurred more frequently in patients
with a history of prior thoracic radiation (6.9%) compared to those
without (2.9%). 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.
KEYTRUDA can cause immune-mediated colitis. Colitis occurred in
48 (1.7%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.4%), 3 (1.1%), and 4 (<0.1%) 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.
KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred
in 19 (0.7%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.1%), 3 (0.4%), 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.
KEYTRUDA can cause hypophysitis. Hypophysitis occurred in 17
(0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.2%), 3 (0.3%), and 4 (<0.1%) hypophysitis. Monitor patients
for signs and symptoms of hypophysitis (including hypopituitarism
and adrenal insufficiency). Administer corticosteroids and hormone
replacement as clinically indicated. Withhold KEYTRUDA
(pembrolizumab) for Grade 2; withhold or discontinue for Grade 3 or
4 hypophysitis.
KEYTRUDA can cause thyroid disorders, including hyperthyroidism,
hypothyroidism, and thyroiditis. Hyperthyroidism occurred in 96
(3.4%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.8%) and 3 (0.1%) hyperthyroidism. Hypothyroidism occurred in 237
(8.5%) of 2799 patients receiving KEYTRUDA, including Grade 2
(6.2%) and 3 (0.1%) hypothyroidism. Thyroiditis occurred in 16
(0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.3%) thyroiditis. 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.
KEYTRUDA can cause type 1 diabetes mellitus, including diabetic
ketoacidosis, which have been reported in 6 (0.2%) of 2799
patients. Monitor patients for hyperglycemia or other signs and
symptoms of diabetes. Administer insulin for type 1 diabetes, and
withhold KEYTRUDA and administer antihyperglycemics in patients
with severe hyperglycemia.
KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred
in 9 (0.3%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.1%), 3 (0.1%), 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
KEYTRUDA can cause other clinically important immune-mediated
adverse reactions. 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 adverse reaction remains at Grade 1 or less following
corticosteroid taper. Permanently discontinue KEYTRUDA
(pembrolizumab) 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
2799 patients: arthritis (1.5%), exfoliative dermatitis, bullous
pemphigoid, rash (1.4%), uveitis, myositis, Guillain-Barré
syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic
anemia, and partial seizures arising in a patient with inflammatory
foci in brain parenchyma.
KEYTRUDA can cause severe or life-threatening infusion-related
reactions, which have been reported in 6 (0.2%) of 2799 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.
KEYTRUDA was discontinued due to adverse reactions in 8% of 682
patients with metastatic NSCLC. The most common adverse event
resulting in permanent discontinuation of KEYTRUDA was pneumonitis
(1.8%). Adverse reactions leading to interruption of KEYTRUDA
occurred in 23% of patients; the most common (≥1%) were diarrhea
(1%), fatigue (1.3%), pneumonia (1%), liver enzyme elevation
(1.2%), decreased appetite (1.3%), and pneumonitis (1%). The most
common adverse reactions (occurring in at least 20% of patients and
at a higher incidence than with docetaxel) were decreased appetite
(25% vs 23%), dyspnea (23% vs 20%), and nausea (20% vs 18%).
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,
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 nearly 400 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.
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908-236-1108orInvestors:Teri Loxam, 908-740-1986Amy Klug,
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