Data for KEYTRUDA® (pembrolizumab) Across 16 Types of Cancer from Merck’s Industry-Leading Immuno-Oncology Program to Be Presented at the 2017 ASCO Annual Meeting
May 17, 2017 4:00 pm ET
Research with KEYTRUDA in Monotherapy and in Combination Includes Findings in Non-Small Cell Lung Cancer (NSCLC), Melanoma, Urothelial Carcinoma, Microsatellite-Instability High (MSI-H) Cancers, Gastric Cancer and Breast Cancer
New Overall Survival Data to be Presented in NSCLC, Melanoma and Urothelial Carcinoma
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that new and updated data from studies of KEYTRUDA®
(pembrolizumab), the company’s anti-PD-1 therapy, will be presented at
the 53rd Annual Meeting of the American Society of Clinical
Oncology (ASCO) in Chicago, June 2 – 6, 2017. At this year’s meeting,
researchers will present data from more than 50 abstracts investigating
the use of KEYTRUDA as monotherapy and in novel combinations across 16
cancers, including non-small cell lung cancer (NSCLC), melanoma,
urothelial carcinoma, microsatellite instability-high (MSI-H) cancers,
gastric cancer and breast cancer. Additional longer-term
progression-free survival (PFS) and overall survival (OS) data for
KEYTRUDA in monotherapy and as a combination therapy in first-line NSCLC
from KEYNOTE-024 and KEYNOTE-021G will be presented. As noted in the
abstracts, in KEYNOTE-024 significant improvement in OS was maintained
with KEYTRUDA compared to chemotherapy with a longer follow-up of
approximately six months; and in KEYNOTE-021G with more than five months
of additional follow-up, a trend for improved OS with KEYTRUDA in
combination with pemetrexed and carboplatin (pem/carbo) was observed
when compared to pem/carbo alone, despite high rates of patient
cross-over. Additional data on these findings will be presented at the
“Our data at ASCO bring to life the potential of KEYTRUDA across many
different cancer types as both monotherapy and in combination, and
underscore the remarkable progress that is being made in the fight
against cancer,” said Dr. Roy Baynes, senior vice president and head of
global clinical development, Chief Medical Officer, Merck Research
Laboratories. “In particular, we continue to show improved survival
outcomes in the first-line treatment of both melanoma and non-small cell
lung cancer, and we highlight clinical collaboration data that explore
the potential of novel immunotherapy combinations as a treatment for
patients with cancer.”
In monotherapy, data for KEYTRUDA (pembrolizumab) will be presented in
NSCLC, melanoma, urothelial carcinoma, gastric cancer and
triple-negative breast cancer (TNBC), among others. In the combination
setting, data for KEYTRUDA in NSCLC, TNBC and endometrial cancer, among
others, will be presented. Additionally, studies providing insight into
the role of biomarkers – such as PD-L1 and microsatellite-instability –
across a variety of tumors and treatment settings will be presented.
Merck continues to advance the study of genomic markers and signals that
can help physicians to identify the treatment regimen that may be best
for each patient.
Merck Data at the 2017 ASCO Annual Meeting
A select listing of the more than 50 Merck-sponsored and collaboration
abstracts featuring KEYTRUDA is provided below. Data from studies of
other oncology medicines in Merck’s portfolio and pipeline will also be
presented at the meeting. For more information, including a complete
list of abstract titles and presentation days and times, please visit
the ASCO website at https://iplanner.asco.org/am2017/#/.
Advanced Bladder Cancers: Merck has the largest immuno-oncology
development program in bladder cancer. In monotherapy, OS results from
KEYNOTE-045, the phase 3 trial of KEYTRUDA compared to chemotherapy for
patients with locally advanced or metastatic advanced urothelial
carcinoma (a type of bladder cancer) in the second-line setting
(Abstract #4501), will be presented. In addition, a biomarker analysis
from KEYNOTE-052, the phase 2 trial of patients with advanced urothelial
carcinoma in the first-line setting who are not eligible for
cisplatin-based chemotherapy (Abstract #4502), will also be presented;
data from both studies served as the basis for supplemental Biologics
License Applications (sBLAs) for KEYTRUDA that are currently under
review with the U.S. Food and Drug Administration (FDA). In the
combination setting, new data will be presented from the phase 1/2
ECHO-202/KEYNOTE-037 study of KEYTRUDA (pembrolizumab) and Incyte’s
investigational oral selective IDO1 enzyme inhibitor, epacadostat, in
patients with advanced urothelial carcinoma (Abstract #4503).
Abstract #4501 Oral Session: Planned survival analysis from
KEYNOTE-045: Phase 3, open-label study of pembrolizumab (pembro)
versus paclitaxel, docetaxel, or vinflunine in recurrent, advanced
urothelial cancer (UC). D. Bajorin. Monday, June 5. 8:12 a.m. – 8:24
a.m. CDT. Location: Arie Crown Theater.
Abstract #4502 Oral Session: Biomarker findings and mature clinical
results from KEYNOTE-052: First-line pembrolizumab (pembro) in
cisplatin-ineligible advanced urothelial cancer (UC). P. O’Donnell.
Monday, June 5. 8:24 a.m. – 8:36 a.m. CDT. Location: Arie Crown
Abstract #4503 Oral Session: Epacadostat plus pembrolizumab in
patients with advanced urothelial carcinoma: Preliminary phase I/II
results of ECHO-202/KEYNOTE-037. D. Smith. Monday, June 5. 8:36 a.m. –
8:48 a.m. CDT. Location: Arie Crown Theater.
Advanced Breast Cancer and Other Women’s Cancers: Merck is
currently conducting several studies investigating the potential for
KEYTRUDA as a monotherapy and as a combination therapy in breast cancer,
and in endometrial, ovarian and cervical cancers. Monotherapy data to be
presented include two of the phase 2 KEYNOTE-086 study cohorts (A & B)
of KEYTRUDA in patients with metastatic TNBC with varying levels of
PD-L1 expression (Abstract #1008 and Abstract #1088, respectively). In
the combination setting, findings will be presented investigating
KEYTRUDA with chemotherapy in the neoadjuvant treatment setting for
high-risk breast cancer (or TNBC) (Abstract #556 and Abstract #506,
respectively), including results from the phase 2 I-SPY 2 TRIAL.
Abstract #1008 Oral Session: Phase 2 study of pembrolizumab
(pembro) monotherapy for previously treated metastatic triple-negative
breast cancer (mTNBC): KEYNOTE-086 cohort A. S. Adams. Saturday, June
3. 3:39 p.m. – 3:51 p.m. CDT. Location: Hall D1.
Abstract #1088 Poster Session: Phase 2 study of pembrolizumab as
first-line therapy for PD-L1–positive metastatic triple-negative
breast cancer (mTNBC): Preliminary data from KEYNOTE-086 cohort B. S.
Adams. Sunday, June 4. 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A.
Abstract #506 Oral Session: Pembrolizumab plus standard neoadjuvant
therapy for high-risk breast cancer (BC): Results from I-SPY 2. R.
Nanda. Monday, June 5. 11:45 a.m. – 11:57 a.m. CDT. Location: Hall D2.
Abstract #556 Poster Session: Pembrolizumab (pembro) + chemotherapy
(chemo) as neoadjuvant treatment for triple negative breast cancer
(TNBC): Preliminary results from KEYNOTE-173. P. Schmid. Sunday, June
4. 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A.
Advanced Gastrointestinal (GI) Cancers: Data will be
presented from the phase 2 registrational KEYNOTE-059 study of KEYTRUDA
(pembrolizumab) in patients with advanced gastric cancer – the
monotherapy cohort (Abstract #4003) and the combination cohort (Abstract
#4012). Additionally, combination data from the clinical collaboration
with Eli Lilly and Company investigating KEYTRUDA with ramucirumab will
be presented (Abstract #4046).
Abstract #4003 Oral Session: KEYNOTE-059 cohort 1: Efficacy and
safety of pembrolizumab (pembro) monotherapy in patients with
previously treated advanced gastric cancer. C. Fuchs. Sunday, June 4.
9:00 a.m. – 9:12 a.m. CDT. Location: Hall D2.
Abstract #4012 Poster Session/Discussion: KEYNOTE-059 cohort 2:
Safety and efficacy of pembrolizumab (pembro) plus 5-fluorouracil
(5-FU) and cisplatin for first-line (1L) treatment of advanced gastric
cancer. YJ. Bang. Saturday, June 3. Poster: 8:00 a.m. – 11:30 a.m.
CDT. Location: Hall A. Discussion: 4:45 p.m. – 6:00 p.m. CDT.
Location: Hall D2.
Abstract #4046 Poster Session: Ramucirumab (R) plus pembrolizumab
(P) in treatment naive and previously treated advanced gastric or
gastroesophageal junction (G/GEJ) adenocarcinoma: A multi-disease
phase I study. I. Chau. Saturday, June 3. 8:00 a.m. – 11:30 a.m. CDT.
Location: Hall A.
Advanced Head and Neck Cancer: In advanced head and neck squamous
cell carcinoma (HNSCC), a study evaluating the role of genomic
determinants of response to KEYTRUDA monotherapy (Abstract #6009) will
be presented. In the combination setting, researchers will present data
from the ECHO-202/KEYNOTE-037 trial, which is studying KEYTRUDA in
combination with Incyte’s epacadostat (Abstract #6010).
Abstract #6009 Clinical Science Symposium: Genomic determinants of
response to pembrolizumab in head and neck squamous cell carcinoma
(HNSCC). R. Haddad. Tuesday, June 6. 8:00 a.m. – 8:12 a.m. CDT.
Abstract #6010 Clinical Science Symposium: Epacadostat plus
pembrolizumab in patients with SCCHN: Preliminary phase I/II results
from ECHO-202/KEYNOTE-037. O. Hamid. Tuesday, June 6. 8:12 a.m. – 8:24
a.m. CDT. Location: S100a.
Advanced Lung Cancer: Merck is continuing to advance
understanding of the important role of KEYTRUDA (pembrolizumab) in
metastatic lung cancer both as monotherapy and in combination with other
therapies. In monotherapy, PFS and updated OS data from the phase 3
KEYNOTE-024 trial of patients with advanced NSCLC whose tumors have high
PD-L1 expression [tumor proportion score (TPS) ≥50%] (Abstract #9000)
will be presented. In the combination setting, additional follow-up will
be presented from the phase 1/2 KEYNOTE-021G study (Abstract #9094),
including OS. KEYNOTE-021G was the basis of the recent approval of
KEYTRUDA in combination with pemetrexed and carboplatin for the
first-line treatment of metastatic nonsquamous NSCLC, irrespective of
PD-L1 expression. In addition, data will be presented from
ECHO-202/KEYNOTE-037 investigating KEYTRUDA with epacadostat in patients
with NSCLC (Abstract #9014).
Abstract #9000 Oral Session: Progression after the next line of
therapy (PFS2) and updated OS among patients (pts) with advanced NSCLC
and PD-L1 tumor proportion score (TPS) ≥50% enrolled in KEYNOTE-024.
J. Brahmer. Tuesday, June 6. 9:45 a.m. – 9:57 a.m. CDT. Location: Hall
Abstract #9094 Poster Session: First-line carboplatin and
pemetrexed (CP) with or without pembrolizumab (pembro) for advanced
nonsquamous NSCLC: Updated results of KEYNOTE-021 cohort G. V.
Papadimitrakopoulou. Saturday, June 3. 8:00 a.m. – 11:30 a.m. CDT.
Location: Hall A.
Abstract #9014 Poster Session/Discussion: Efficacy and safety of
epacadostat plus pembrolizumab treatment of NSCLC: Preliminary phase
I/II results of ECHO-202/KEYNOTE-037. T. Gangadhar. Saturday, June 3.
Poster: 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A. Discussion: 3:00
p.m. – 4:15 p.m. CDT. Location: Hall D2.
Advanced Melanoma: In monotherapy, longer-term OS data from the
phase 3 KEYNOTE-006 trial (Abstract #9504) of KEYTRUDA will be
presented. In combination studies, early findings from the phase 1b/2
KEYNOTE-184 study of Dynavax’s intratumoral SD-101 in combination with
KEYTRUDA in anti-PD-1 naïve and experienced metastatic melanoma patients
(Abstract #9550) will be presented, as will updated data from the
KEYNOTE-029 study of KEYTRUDA with ipilimumab (Abstract #9545). In
addition, data from the phase 2 KEYNOTE-142 study of Syndax’s entinostat
in combination with KEYTRUDA (pembrolizumab) in patients with advanced
melanoma (Abstract #9529) will be presented for the first time.
Abstract #9504 Oral Session: Long-term outcomes in patients (pts)
with ipilimumab (ipi)-naive advanced melanoma in the phase 3
KEYNOTE-006 study who completed pembrolizumab (pembro) treatment. C.
Robert. Sunday, June 4. 9:12 a.m. – 9:24 a.m. CDT. Location: Arie
Abstract #9550 Poster Session: Phase 1b/2, open label, multicenter,
study of intratumoral SD-101 in combination with pembrolizumab in
anti-PD1 naïve & experienced metastatic melanoma patients. A. Leung.
Saturday, June 3. 1:15 p.m. – 4:45 p.m. CDT. Location: Hall A.
Abstract #9545 Poster Session: KEYNOTE-029: Efficacy and safety of
pembrolizumab (pembro) plus ipilimumab (ipi) for advanced melanoma. M.
Carlino. Saturday, June 3. 1:15 p.m. – 4:45 p.m. CDT. Location: Hall A.
Abstract #9529 Poster Session: Melanoma/Skin Cancers, ENCORE 601: A
phase II study of entinostat (ENT) in combination with pembrolizumab
(PEMBRO) in patients with melanoma. M. Johnson. Saturday, June 3. 1:15
p.m. – 4:45 p.m. CDT. Location: Hall A.
Advanced Microsatellite-Instability (MSI) High Cancers: Merck is
advancing the use of biomarkers to guide clinical decision making,
including for patients with MSI-High advanced malignancies. At ASCO,
monotherapy data from KEYNOTE-164 and KEYNOTE-158 will be presented in
patients with high levels of MSI (Abstract #3071).
Abstract #3071 Poster Session: Pembrolizumab therapy for
microsatellite instability high (MSI-H) colorectal cancer (CRC) and
non-CRC. L. Diaz. Monday, June 5. 8:00 a.m. – 11:30 a.m. CDT.
Location: Hall A.
Advanced Renal Cell Carcinoma (RCC): New data from studies of
KEYTRUDA in combination in patients with advanced RCC will also be
presented, including preliminary data for KEYTRUDA combined with
epacadostat from the ECHO-202/KEYNOTE-037 trial (Abstract #4515) and for
KEYTRUDA combined with Novartis’ pazopanib (Abstract #4506).
Abstract #4515 Poster Session/Discussion: Epacadostat plus
pembrolizumab in patients with advanced RCC: Preliminary phase I/II
results from ECHO-202/KEYNOTE-037. P. Lara. Sunday, June 4. Poster:
8:00 a.m. – 11:30 a.m. CDT. Location: Hall A. Discussion: 11:30 a.m. –
12:45 a.m. CDT. Location: Arie Crown Theater.
Abstract #4506 Oral Session: A phase I/II study to assess the
safety and efficacy of pazopanib (PAZ) and pembrolizumab (PEM) in
patients (pts) with advanced renal cell carcinoma (aRCC). S.
Chowdhury. Monday, June 5. 9:36 a.m. – 9:48 a.m. CDT. Location: Arie
Merck Investor Event: Merck will hold an investor event in
conjunction with the 2017 ASCO Annual Meeting on Monday, June 5 at 5:45
p.m. CDT (6:45 p.m. EDT). Investors, analysts, members of the media and
the general public are invited to listen to a live audio webcast of the
presentation at http://investors.merck.com/events-and-presentations/default.aspx
or by dialing (866) 486-2604 – and using ID code number 3314336.
KEYTRUDA 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.
Studies of KEYTRUDA – from the largest immuno-oncology program in the
industry with more than 500 trials – include a wide variety of cancers
and treatment settings. The KEYTRUDA clinical program seeks to
understand factors that predict a patient’s likelihood of benefitting
from treatment with KEYTRUDA, including the exploration of several
different biomarkers across a broad range of tumors.
KEYTRUDA 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.
KEYTRUDA, 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
KEYTRUDA (pembrolizumab), 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 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.
Classical Hodgkin Lymphoma
KEYTRUDA 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.
Selected Important Safety Information for KEYTRUDA
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
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. 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 (pembrolizumab) for Grade 3 or 4
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 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. In addition,
myelitis and myocarditis were reported in other clinical trials,
including classical Hodgkin lymphoma, and postmarketing 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 benefit of treatment with
KEYTRUDA vs the risk of possible organ rejection in these patients.
KEYTRUDA (pembrolizumab) 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.
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.
KEYTRUDA 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%).
When KEYTRUDA was administered in combination with pemetrexed and
carboplatin, 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 (pembrolizumab) 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%). The study was not designed to
demonstrate a statistically significant difference in adverse reaction
rates for KEYTRUDA plus chemotherapy, as compared to chemotherapy alone,
for any specified adverse reaction.
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.
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 more than 500 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.
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and partnerships. Today, Merck continues to be at the forefront of
research to advance the prevention and treatment of diseases that
threaten people and communities around the world – including cancer,
cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease
and infectious diseases including HIV and Ebola. For more information,
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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 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
Patient Information/Medication Guide for KEYTRUDA at
Pamela Eisele, 267-305-3558
Courtney Ronaldo, 908-740-6132
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898