Two New Trials of Merck’s KEYTRUDA® (pembrolizumab) as Monotherapy and in Combination with Chemotherapy for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer to be Presented During Presidential Session at ESMO 2016
September 28, 2016 5:45 am ET
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
KENILWORTH, N.J.–(BUSINESS WIRE)–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
(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.
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.
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
KEYTRUDA is indicated for the treatment of patients with unresectable or
metastatic melanoma at a dose of 2 mg/kg every three weeks.
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
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
Selected Important Safety Information for KEYTRUDA
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
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
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
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.
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
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Please see Prescribing Information for KEYTRUDA (pembrolizumab) at
Patient Information/Medication Guide for KEYTRUDA at
Pamela Eisele, 267-305-3558
Kim Hamilton, 908-740-1863
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898