Data Showed Median Overall Survival of 30.0
Months for KEYTRUDA Group Compared to 14.2 Months for Chemotherapy
Group
Findings from KEYNOTE-024 to Be Presented at
World Conference on Lung Cancer
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced the presentation of updated overall
survival (OS) findings, a secondary endpoint, from the phase 3
KEYNOTE-024 trial evaluating KEYTRUDA® (pembrolizumab), the
company’s anti-PD-1 therapy, as a first-line monotherapy in
patients with non-small cell lung cancer (NSCLC) whose tumors
express high levels of PD-L1 (tumor proportion score [TPS] of 50
percent or more). The study included patients with squamous and
nonsquamous NSCLC with no EGFR or ALK genomic tumor aberrations.
Findings – which are based on more than two years of follow-up –
will be presented in an oral presentation at the 18th World
Conference on Lung Cancer (WCLC) hosted by the International
Association for the Study of Lung Cancer in Yokohama, Japan
(Abstract OA 17.06).
With an additional six months of available data, results
continue to show a reduction in the risk of death by 37 percent for
KEYTRUDA compared to chemotherapy based on more than two years of
median follow-up (HR, 0.63 [95% CI, 0.47–0.86]; nominal p=0.002).
Additionally, KEYTRUDA increased OS by more than one year, more
than double the OS for chemotherapy (30.0 months [95% CI, 18.3–not
reached]; 14.2 months [95% CI, 9.8–19.0], respectively).
“As we continue to see updated findings from this study of
patients with non-small cell lung cancer in the first-line setting,
practioners are gaining valuable insights into the longer-term
clinical benefit of KEYTRUDA,” said Prof. Martin Reck, head of the
department of thoracic oncology, LungenClinic Grosshansdorf,
Germany. “The significant overall survival findings observed in
KEYNOTE-024, which includes patients who have a poor prognosis,
reinforce the use of KEYTRUDA in appropriate patients in the
first-line treatment of this disease.”
Merck has an extensive research program in NSCLC and is
currently advancing multiple registration-enabling studies with
KEYTRUDA (pembrolizumab) as monotherapy and in combination with
other treatments.
“The focus of our clinical program has always been to improve
survival for people with cancer,” said Dr. Roger Dansey, senior
vice president and therapeutic area head, oncology late-stage
development, Merck Research Laboratories. “With these findings
from KEYNOTE-024, we continue to demonstrate the potential for
KEYTRUDA to have a positive impact on survival outcomes in
non-small cell lung cancer.”
Data from KEYNOTE-024 Study (Abstract OA
17.06)KEYNOTE-024 studied 305 patients with metastatic NSCLC
who were assigned either KEYTRUDA as monotherapy (n=154) or
standard of care platinum-based chemotherapy (n=151). Enrollment
criteria included: having no prior systemic chemotherapy treatment
for their advanced disease, tumors without an EGFR sensitizing
mutation or ALK translocation, and tumors expressing high levels of
PD-L1 (TPS of 50 percent or more) as determined by a central
laboratory FDA-approved test. The primary endpoint was
progression-free survival (PFS) and the key secondary endpoint was
OS. Other secondary endpoints include overall response rate (ORR)
and safety. Exploratory endpoints include duration of response.
Data presented at WCLC are based on a median follow-up of 25.2
months in 305 patients and include findings from 82 patients who
crossed over from the chemotherapy group to receive KEYTRUDA, per
study protocol, and 12 patients who received anti-PD-1 therapy
outside of study crossover, totaling a 62.3 percent effective
crossover rate.
With an additional six months of follow-up, an analysis of OS
demonstrated that the median OS for the KEYTRUDA group was 30.0
months (95% CI, 18.3–not reached) and the median OS for the
chemotherapy group was 14.2 months (95% CI, 9.8–19.0). Consistent
with previously reported findings, KEYTRUDA was also associated
with a 37 percent reduction in the risk of death compared to
chemotherapy (HR, 0.63 [95% CI, 0.47-0.86]; nominal p=0.002). The
24-month OS rate was 51.5 percent in the KEYTRUDA group compared to
34.5 percent in the chemotherapy group; at 12 months, the OS rate
was 70.3 percent in the KEYTRUDA (pembrolizumab) group compared to
54.8 percent in the chemotherapy group.
ORR was 45.5 percent (95% CI, 37.4-53.7) in the KEYTRUDA group
compared to 29.8 percent (95% CI, 22.6-37.8) in the chemotherapy
group. Median duration of response was not reached in the KEYTRUDA
group (range: 1.8+ to 20.6+ months) compared to 7.1 months (range:
2.1+ to 18.1+) in the chemotherapy group.
The safety of KEYTRUDA was consistent with what has been seen in
previous trials among patients with metastatic NSCLC. In the
KEYTRUDA group, 31.2 percent of patients experienced Grade 3-5
treatment-related adverse events (TRAEs). The most common TRAEs for
KEYTRUDA were diarrhea, fatigue, pyrexia, pruritus, nausea,
decreased appetite and rash. The most common immune-mediated
adverse events in patients receiving KEYTRUDA were hypothyroidism,
pneumonitis, hyperthyroidism, severe skin toxicity and infusion
reactions. There was one treatment-related death in the KEYTRUDA
group.
About Lung CancerLung cancer, which forms in the tissues
of the lungs, usually within cells lining the air passages, is the
leading cause of cancer death worldwide. Each year, more people die
of lung cancer than colon, breast and prostate cancers combined.
The two main types of lung cancer are non-small cell and small
cell. NSCLC is the most common type of lung cancer, accounting for
about 85 percent of all cases. The five-year survival rate for
patients suffering from highly advanced, metastatic (Stage IV) lung
cancers is estimated to be two percent.
About KEYTRUDA ® (pembrolizumab)
Injection 100 mgKEYTRUDA is an anti-PD-1 therapy that
works by increasing the ability of the body’s immune system to help
detect and fight tumor cells. KEYTRUDA is a humanized monoclonal
antibody that 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.
Merck has the industry’s largest immuno-oncology clinical
research program, which currently involves more than 600 trials
studying KEYTRUDA across a wide variety of cancers and treatment
settings. The KEYTRUDA clinical program seeks to understand the
role of KEYTRUDA across cancers and the factors that may predict a
patient’s likelihood of benefitting from treatment with KEYTRUDA,
including exploring several different biomarkers.
KEYTRUDA (pembrolizumab) Indications and Dosing
MelanomaKEYTRUDA is indicated for the treatment of patients with
unresectable or metastatic melanoma at a fixed dose of 200 mg every
three weeks until disease progression or unacceptable toxicity.
Lung CancerKEYTRUDA, as a single agent, 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, as a single agent, 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.
KEYTRUDA, in combination with pemetrexed and carboplatin, is
indicated for the first-line treatment of patients with metastatic
nonsquamous NSCLC. This indication is approved under accelerated
approval based on tumor response rate and progression-free
survival. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in the
confirmatory trials.
In metastatic NSCLC, 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.
When administering KEYTRUDA in combination with chemotherapy,
KEYTRUDA should be administered prior to chemotherapy when given on
the same day. See also the Prescribing Information for pemetrexed
and carboplatin.
Head and Neck CancerKEYTRUDA 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 (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.
Classical Hodgkin LymphomaKEYTRUDA is indicated for the
treatment of adult and pediatric patients with refractory classical
Hodgkin lymphoma (cHL), or who have relapsed after three or more
prior lines of therapy. 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 adults with cHL, KEYTRUDA is administered
at a fixed dose of 200 mg every three weeks until disease
progression or unacceptable toxicity, or up to 24 months in
patients without disease progression. In pediatric patients with
cHL, KEYTRUDA is administered at a dose of 2 mg/kg (up to a maximum
of 200 mg) every three weeks until disease progression or
unacceptable toxicity, or up to 24 months in patients without
disease progression.
Urothelial CarcinomaKEYTRUDA is indicated for the treatment of
patients with locally advanced or metastatic urothelial carcinoma
who are not eligible for cisplatin-containing chemotherapy. This
indication is approved under accelerated approval based on tumor
response rate and duration of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials.
KEYTRUDA is also indicated for the treatment of patients with
locally advanced or metastatic urothelial carcinoma who have
disease progression during or following platinum-containing
chemotherapy or within 12 months of neoadjuvant or adjuvant
treatment with platinum-containing chemotherapy.
In locally advanced or metastatic urothelial carcinoma, KEYTRUDA
is administered at a fixed dose of 200 mg every three weeks until
disease progression or unacceptable toxicity, or up to 24 months in
patients without disease progression.
Microsatellite Instability-High (MSI-H) CancerKEYTRUDA is
indicated for the treatment of adult and pediatric patients with
unresectable or metastatic microsatellite instability-high (MSI-H)
or mismatch repair deficient (dMMR)
- solid tumors that have progressed
following prior treatment and who have no satisfactory alternative
treatment options, or
- colorectal cancer that has progressed
following treatment with fluoropyrimidine, oxaliplatin, and
irinotecan.
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. The
safety and effectiveness of KEYTRUDA (pembrolizumab) in pediatric
patients with MSI-H central nervous system cancers have not been
established.
In adult patients with MSI-H cancer, 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. In children with MSI-H cancer, KEYTRUDA is
administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every
three weeks until disease progression or unacceptable toxicity, or
up to 24 months in patients without disease progression.
Gastric CancerKEYTRUDA is indicated for the treatment of
patients with recurrent locally advanced or metastatic gastric or
gastroesophageal junction (GEJ) adenocarcinoma whose tumors express
PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an
FDA-approved test, with disease progression on or after two or more
prior lines of therapy including fluoropyrimidine- and
platinum-containing chemotherapy and if appropriate,
HER2/neu-targeted therapy. 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. The recommended dose of KEYTRUDA is 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 (pembrolizumab) 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 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. The incidence of new or
worsening hypothyroidism was higher in patients with HNSCC,
occurring in 28 (15%) of 192 patients with HNSCC, including Grade 3
(0.5%) 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 (pembrolizumab) 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.
Immune-mediated rashes, including Stevens-Johnson syndrome
(SJS), toxic epidermal necrolysis (TEN) (some cases with fatal
outcome), exfoliative dermatitis, and bullous pemphigoid, can
occur. Monitor patients for suspected severe skin reactions and
based on the severity of the adverse reaction, withhold or
permanently discontinue KEYTRUDA and administer corticosteroids.
For signs and symptoms of SJS or TEN, withhold KEYTRUDA and refer
the patient for specialized care for assessment and treatment. If
SJS or TEN is confirmed, permanently discontinue KEYTRUDA.
KEYTRUDA can cause other clinically important immune-mediated
adverse reactions. These immune-mediated reactions may occur in any
organ system. 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 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%), uveitis, myositis, Guillain-Barré
syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic
anemia, and partial seizures arising in a patient with inflammatory
foci in brain parenchyma. In addition, myelitis and myocarditis
were reported in other clinical trials, including classical Hodgkin
lymphoma, and post-marketing use.
Solid organ transplant rejection has been reported in
postmarketing use of KEYTRUDA. Treatment with KEYTRUDA may increase
the risk of rejection in solid organ transplant recipients.
Consider the benefit of treatment with KEYTRUDA (pembrolizumab) vs
the risk of possible organ rejection in these patients.
KEYTRUDA can cause severe or life-threatening infusion-related
reactions, including hypersensitivity and anaphylaxis, 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.
Immune-mediated complications, including fatal events, occurred
in patients who underwent allogeneic hematopoietic stem cell
transplantation (HSCT) after being treated with KEYTRUDA. Of 23
patients with cHL who proceeded to allogeneic HSCT after treatment
with KEYTRUDA on any trial, 6 patients (26%) developed
graft-versus-host disease (GVHD), one of which was fatal, and 2
patients (9%) developed severe hepatic veno-occlusive disease (VOD)
after reduced-intensity conditioning, one of which was fatal. Cases
of fatal hyperacute GVHD after allogeneic HSCT have also been
reported in patients with lymphoma who received a PD-1
receptor–blocking antibody before transplantation. These
complications may occur despite intervening therapy between PD-1
blockade and allogeneic HSCT. Follow patients closely for early
evidence of transplant-related complications such as hyperacute
GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile
syndrome, hepatic VOD, and other immune-mediated adverse reactions,
and intervene promptly.
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.
In KEYNOTE-010, KEYTRUDA (pembrolizumab) monotherapy 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%).
In KEYNOTE-021G(1), when KEYTRUDA was administered in
combination with carboplatin and pemetrexed (carbo/pem) in advanced
nonsquamous NSCLC, KEYTRUDA was discontinued in 10% of 59 patients.
The most common adverse reaction resulting in discontinuation of
KEYTRUDA (≥2%) was acute kidney injury (3.4%). Adverse reactions
leading to interruption of KEYTRUDA occurred in 39% of patients;
the most common (≥2%) were fatigue (8%), neutrophil count decreased
(8%), anemia (5%), dyspnea (3.4%), and pneumonitis (3.4%).The most
common adverse reactions (≥20%) with KEYTRUDA compared to carbo/pem
alone were fatigue (71% vs 50%), nausea (68% vs 56%), constipation
(51% vs 37%), rash (42% vs 21%), vomiting (39% vs 27%), dyspnea
(39% vs 21%), diarrhea (37% vs 23%), decreased appetite (31% vs
23%), headache (31% vs 16%), cough (24% vs 18%), dizziness (24% vs
16%), insomnia (24% vs 15%), pruritus (24% vs 4.8%), peripheral
edema (22% vs 18%), dysgeusia (20% vs 11%), alopecia (20% vs 3.2%),
upper respiratory tract infection (20% vs 3.2%), and arthralgia
(15% vs 24%). This study was not designed to demonstrate a
statistically significant difference in adverse reaction rates for
KEYTRUDA as compared to carbo/pem alone for any specified adverse
reaction.
In KEYNOTE-012, 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, decreased
appetite, and dyspnea. Adverse reactions occurring in patients with
HNSCC were generally similar to those occurring in patients with
melanoma or NSCLC, with the exception of increased incidences of
facial edema (10% all Grades; 2.1% Grades 3 or 4) and new or
worsening hypothyroidism.
In KEYNOTE-087, KEYTRUDA was discontinued due to adverse
reactions in 5% of 210 patients with cHL, and treatment was
interrupted due to adverse reactions in 26% of patients. Fifteen
percent (15%) of patients had an adverse reaction requiring
systemic corticosteroid therapy. Serious adverse reactions occurred
in 16% of patients. The most frequent serious adverse reactions
(≥1%) included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and
herpes zoster. Two patients died from causes other than disease
progression; one from GVHD after subsequent allogeneic HSCT and one
from septic shock. The most common adverse reactions (occurring in
≥20% of patients) were fatigue (26%), pyrexia (24%), cough (24%),
musculoskeletal pain (21%), diarrhea (20%), and rash (20%).
In KEYNOTE-052, KEYTRUDA (pembrolizumab) was discontinued due to
adverse reactions in 11% of 370 patients with locally advanced or
metastatic urothelial carcinoma. The most common adverse reactions
(in≥20% of patients) were fatigue (38%), musculoskeletal pain
(24%), decreased appetite (22%), constipation (21%), rash (21%),
and diarrhea (20%). Eighteen patients (5%) died from causes other
than disease progression. Five patients (1.4%) who were treated
with KEYTRUDA experienced sepsis which led to death, and 3 patients
(0.8%) experienced pneumonia which led to death. Adverse reactions
leading to interruption of KEYTRUDA occurred in 22% of patients;
the most common (≥1%) were liver enzyme increase, diarrhea, urinary
tract infection, acute kidney injury, fatigue, joint pain, and
pneumonia. Serious adverse reactions occurred in 42% of patients,
the most frequent (≥2%) of which were urinary tract infection,
hematuria, acute kidney injury, pneumonia, and urosepsis.
In KEYNOTE-045, KEYTRUDA was discontinued due to adverse
reactions in 8% of 266 patients with locally advanced or metastatic
urothelial carcinoma. The most common adverse reaction resulting in
permanent discontinuation of KEYTRUDA was pneumonitis (1.9%).
Adverse reactions leading to interruption of KEYTRUDA occurred in
20% of patients; the most common (≥1%) were urinary tract infection
(1.5%), diarrhea (1.5%), and colitis (1.1%). The most common
adverse reactions (20%) in patients who received KEYTRUDA vs those
who received chemotherapy were fatigue (38% vs 56%),
musculoskeletal pain (32% vs 27%), pruritus (23% vs 6%), decreased
appetite (21% vs 21%), nausea (21% vs 29%), and rash (20% vs 13%).
Serious adverse reactions occurred in 39% of KEYTRUDA-treated
patients, the most frequent (≥2%) of which were urinary tract
infection, pneumonia, anemia, and pneumonitis.
There is limited experience in pediatric patients. Efficacy for
pediatric patients was extrapolated from the results in the adult
cHL population. In a study of 40 pediatric patients with advanced
melanoma, PD-L1–positive advanced, relapsed, or refractory solid
tumors or lymphoma, patients were treated with KEYTRUDA for a
median of 43 days (range 1-414 days), with 24 patients (60%)
receiving treatment for 42 days or more. The safety profile in
pediatric patients was similar to that seen in adults treated with
KEYTRUDA. Toxicities that occurred at a higher rate (≥15%
difference) in these patients when compared to adults under 65
years of age were fatigue (45%), vomiting (38%), abdominal pain
(28%), hypertransaminasemia (28%), and hyponatremia (18%).
It is not known whether KEYTRUDA (pembrolizumab) 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.
Our Focus on CancerOur 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 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 MerckFor more than a century, Merck, a leading
global biopharmaceutical company known as MSD outside of the United
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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 2016
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
version on businesswire.com: http://www.businesswire.com/news/home/20171018005418/en/
Merck & Co., Inc.Media:Pamela Eisele, 267-305-3558orTeresa
Mueller, 908-740-1884orInvestors:Teri Loxam, 908-740-1986orAmy
Klug, 908-740-1898
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