Data at ASCO Evaluates KEYTRUDA As Single
Agent and in Novel Combinations in More Than 15 Different Cancers,
Including Several New Tumors
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced that new and updated data investigating
KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in more
than 15 types of cancer will be presented at the 52nd Annual
Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago, June 3 – 7, 2016.
At this year’s meeting, researchers will present data from
studies of KEYTRUDA as a single agent, and in combination with
other therapies, in melanoma and non-small cell lung cancer
(NSCLC), as well as bladder, colorectal, esophageal, gastric, head
and neck, renal cancers, lymphoma and multiple myeloma. First-time
presentation of findings for KEYTRUDA will be presented in new
tumor types including cervical, endometrial, leiomyosarcoma,
pancreatic, salivary, and thyroid. Several abstracts were chosen to
be presented as oral presentations – one of which includes
three-year survival data for patients with advanced melanoma
(abstract #9503); this abstract will be featured in the official
ASCO press program on Wednesday, May 18 at 12:00 p.m. EDT.
“This year’s ASCO annual meeting represents a significant
milestone for the KEYTRUDA clinical development program, which now
includes more than 270 ongoing or planned studies across more than
30 tumor types, both as a single agent and in combination with
other therapies,” said Dr. Roy Baynes, senior vice president and
head of global clinical development, Merck Research Laboratories.
“We look forward to sharing new data with the cancer community from
our industry-leading immuno-oncology program as we seek to advance
our shared goal of transforming outcomes for patients across a
broad range of tumors.”
KEYTRUDA (pembrolizumab) Data at the 2016 ASCO Annual
Meeting
A select list of abstracts and sessions featuring KEYTRUDA data
– including oral presentations, clinical science symposia, posters,
and poster discussions – are provided below:
Advanced Melanoma: Merck has established a broad data set
for KEYTRUDA in the treatment of advanced melanoma. At ASCO, oral
presentations supporting the use of KEYTRUDA in the currently
approved indication will include three-year overall survival (OS)
data from the KEYNOTE-001 trial and a final OS analysis from the
KEYNOTE-006 trial. Additionally, new and updated findings building
on the growing body of research evaluating KEYTRUDA in combination
with other therapies will be presented.
- (Abstract #9503) Oral
Abstract Session: Three-year overall survival for patients
with advanced melanoma treated with pembrolizumab in
KEYNOTE-001. C. Robert. Monday, June 6. 2:15 p.m. – 2:27 p.m.
CDT. Location: Arie Crown Theater.
- (Abstract #9504) Oral Abstract
Session: Pembrolizumab versus ipilimumab for advanced
melanoma: Final overall survival analysis of KEYNOTE-006. J.
Schachter. Monday, June 6. 2:27 p.m. – 2:39 p.m. CDT. Location:
Arie Crown Theater.
- (Abstract #9506) Oral
Abstract Session: Pembrolizumab (pembro) plus ipilimumab
(ipi) for advanced melanoma: Results of the KEYNOTE-029 expansion
cohort. G. Long. Monday, June 6. 2:51 p.m. – 3:03 p.m. CDT.
Location: Arie Crown Theater.
- (Abstract #9568) Poster Session:
Efficacy analysis of MASTERKEY-265 phase 1b study of talimogene
laherparepvec (T-VEC) and pembrolizumab (pembro) for unresectable
stage IIIB-IV melanoma. G. Long. Saturday, June 4. 1:00 p.m. –
4:30 p.m. CDT. Location: Hall A.
- (Abstract #3014) Poster
Session/Discussion: Pembrolizumab (pembro) in combination with
dabrafenib (D) and trametinib (T) for BRAF-mutant advanced
melanoma: Phase 1 KEYNOTE-022 study. A. Ribas. Sunday, June 5.
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 B1.
Advanced Lung Cancer: Merck is continuing to advance the
understanding of KEYTRUDA in lung cancer as a single agent and in
combination with other therapies. Research to be presented at ASCO
includes data from the KEYNOTE-010 trial in advanced NSCLC, as well
as studies exploring PD-L1 expression, long-term survival, and
combination with chemotherapy as a first-line therapy.
- (Abstract #9026) Poster Session:
Long-term OS for patients with advanced NSCLC enrolled in the
KEYNOTE-001 study of pembrolizumab (pembro). R Hui. Saturday,
June 4. 8:00 a.m. – 11:30 a.m. CDT. Location: Hall A.
- (Abstract #9024) Poster Session:
Pembrolizumab vs docetaxel for previously treated advanced NSCLC
with a PD-L1 tumor proportion score (TPS) 1%-49%: Results from
KEYNOTE-010. E. Garon. Saturday, June 4. 8:00 a.m. – 11:30 a.m.
CDT. Location: Hall A.
- (Abstract #9015) Poster
Session/Discussion: Relationship between level of PD-L1 expression
and outcomes in the KEYNOTE-010 study of pembrolizumab vs docetaxel
for previously treated, PD-L1-Positive NSCLC. P. Baas.
Saturday, June 4. Poster: 8:00 a.m. – 11:30 a.m. CDT. Location:
Hall A. Discussion: 3:00 p.m. – 4:15 p.m. CDT. Location:
E354b.
- (Abstract #9016) Poster
Session/Discussion: Pembrolizumab (pembro) plus chemotherapy as
front-line therapy for advanced NSCLC: KEYNOTE-021 cohorts A-C.
S. Gadgeel. Saturday, June 4. Poster: 8:00 a.m. – 11:30 a.m. CDT.
Location: Hall A. Discussion: 3:00 p.m. – 4:15 p.m. CDT. Location:
E354b.
Advanced Head and Neck Cancer: With multiple
registration-enabling studies, Merck currently has the largest
immuno-oncology clinical development program in head and neck
cancer and is advancing research investigating OS and
progression-free survival (PFS) endpoints with single agent
KEYTRUDA (pembrolizumab), as well as in combination with
chemotherapy compared to standard of care. At ASCO, presentations
in this tumor type will include first-time findings from the
KEYNOTE-055 trial in head and neck squamous cell carcinoma (HNSCC)
and updated findings from the KEYNOTE-012 trial, which was the
first clinical study investigating the role of a PD-1 inhibitor in
recurrent or metastatic head and neck cancer and served as the
basis for the KEYTRUDA supplemental Biologics License Application
(sBLA) filing.
- (Abstract #6012) Clinical Science
Symposium: Efficacy and safety of pembrolizumab in
recurrent/metastatic head and neck squamous cell carcinoma (R/M
HNSCC): Pooled analyses after long-term follow-up in
KEYNOTE-012. R. Mehra. Monday, June 6. 12:18 p.m. – 12:30 p.m.
CDT. Location: S100bc.
- (Abstract #6011) Clinical Science
Symposium: Preliminary results from KEYNOTE-055: Pembrolizumab
after platinum and cetuximab failure in head and neck squamous cell
carcinoma (HNSCC). J. Bauml. Monday, June 6. 12:06 p.m. – 12:18
p.m. CDT. Location: S100bc.
- (Abstract #6017) Poster
Session/Poster Discussion Session: Preliminary results for the
advanced salivary gland carcinoma cohort of the phase 1b
KEYNOTE-028 study of pembrolizumab. R. Cohen. Saturday, June 4.
Poster: 1:00 p.m. – 4:30 p.m. CDT. Location: Hall A. Discussion:
4:45 p.m. – 6:00 p.m. CDT. Location: S406.
- (Abstract #6010) Clinical Science
Symposium: Biomarkers and response to pembrolizumab (pembro) in
recurrent/metastatic head and neck squamous cell carcinoma (R/M
HNSCC). L. Chow. Monday, June 6. 11:42 a.m. – 11:54 a.m. CDT.
Location: S100bc.
Advanced Hematological Cancers: Data in several
hematological cancers will be presented at ASCO, including new
findings from the KEYNOTE-087 trial evaluating single agent
KEYTRUDA (pembrolizumab) in patients with classical Hodgkin
lymphoma (cHL), which supported the recent Breakthrough Therapy
Designation granted to KEYTRUDA by the U.S. Food and Drug
Administration (FDA). A final analysis of the KEYNOTE-023 trial,
investigating KEYTRUDA in combination with two commonly used
treatments for multiple myeloma, will also be presented.
- (Abstract #7555) Poster
Session/Discussion: Pembrolizumab for relapsed/refractory classical
Hodgkin lymphoma (R/R cHL): phase 2 KEYNOTE-087 study. R. Chen.
Monday June 6. Poster: 8:00 a.m. – 11:30 a.m. CDT. Location: Hall
A. Discussion: 1:15 p.m. – 2:45 p.m. CDT. Location: E345b.
- (Abstract #8010) Clinical Science
Symposium: Pembrolizumab in combination with lenalidomide and
low-dose dexamethasone for relapsed/refractory multiple myeloma
(RRMM): Final efficacy and safety analysis. M. Mateos. Tuesday,
June 7. 10:09 a.m. – 10:21 a.m. CDT. Location: E354b.
Additional Data from Merck’s Oncology Portfolio
Data from studies of other medicines in Merck’s portfolio and
pipeline will also be presented at the meeting. For more
information, including a complete list of abstract titles, please
visit the ASCO website at https://iplanner.asco.org/AM2016/#/.
About KEYTRUDA® (pembrolizumab) Injection 100
mg
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 indicated for the treatment of patients with
unresectable or metastatic melanoma.
KEYTRUDA is also 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. Patients
with EGFR or ALK genomic tumor aberrations should have disease
progression on FDA-approved therapy for these aberrations prior to
receiving KEYTRUDA. This indication is approved under accelerated
approval based on tumor response rate and durability of response.
An improvement in survival or disease-related symptoms has not yet
been established. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
the confirmatory trials.
KEYTRUDA is administered at a dose of 2 mg/kg as an intravenous
infusion over 30 minutes every three weeks for the approved
indications.
Selected Important Safety Information for
KEYTRUDA® (pembrolizumab)
Immune-mediated pneumonitis, including fatal cases, occurred in
patients receiving KEYTRUDA. Pneumonitis occurred in 32 (2.0%) of
1567 patients with melanoma, including Grade 1 (0.8%), 2 (0.8%),
and 3 (0.4%) pneumonitis. Pneumonitis occurred in 19 (3.5%) of 550
patients with NSCLC, including Grade 2 (1.1%), 3 (1.3%), 4 (0.4%),
or 5 (0.2%) pneumonitis and more frequently in patients with a
history of asthma/chronic obstructive pulmonary disease (5.4%) or
prior thoracic radiation (6.0%). Monitor patients for signs and
symptoms of pneumonitis. Evaluate suspected pneumonitis with
radiographic imaging. Administer corticosteroids for Grade 2 or
greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently
discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2
pneumonitis.
Immune-mediated colitis occurred in 31 (2%) of 1567 patients
with melanoma, including Grade 2 (0.5%), 3 (1.1%), and 4 (0.1%)
colitis. Immune-mediated colitis occurred in 4 (0.7%) of 550
patients with NSCLC, including Grade 2 (0.2%) or 3 (0.4%) colitis.
Monitor patients for signs and symptoms of colitis. Administer
corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA
(pembrolizumab) for Grade 2 or 3; permanently discontinue KEYTRUDA
for Grade 4 colitis.
Immune-mediated hepatitis occurred in patients receiving
KEYTRUDA. Hepatitis occurred in 16 (1%) of 1567 patients with
melanoma, including Grade 2 (0.1%), 3 (0.7%), and 4 (0.1%)
hepatitis. Monitor patients for changes in liver function.
Administer corticosteroids for Grade 2 or greater hepatitis and,
based on severity of liver enzyme elevations, withhold or
discontinue KEYTRUDA .
Hypophysitis occurred in 13 (0.8%) of 1567 patients with
melanoma, including Grade 2 (0.3%), 3 (0.3%), and 4 (0.1%)
hypophysitis. Hypophysitis occurred in 1 (0.2 %) of 550 patients
with NSCLC, which was Grade 3 in severity. Monitor patients for
signs and symptoms of hypophysitis (including hypopituitarism and
adrenal insufficiency). Administer corticosteroids and hormone
replacement as clinically indicated. Withhold KEYTRUDA for Grade 2;
withhold or discontinue for Grade 3 or 4 hypophysitis.
Hyperthyroidism occurred in 51 (3.3%) of 1567 patients with
melanoma, including Grade 2 (0.6%) and 3 (0.1%) hyperthyroidism.
Hypothyroidism occurred in 127 (8.1%) of 1567 patients with
melanoma, including Grade 3 (0.1%) hypothyroidism. Hyperthyroidism
occurred in 10 (1.8%) of 550 patients with NSCLC, including Grade 2
(0.7%) or 3 (0.3%) hyperthyroidism. Hypothyroidism occurred in 38
(6.9%) of 550 patients with NSCLC, including Grade 2 (5.5%) or 3
(0.2%) hypothyroidism. 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
(pembrolizumab) 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
and administer corticosteroids. Upon improvement to Grade 1 or
less, initiate corticosteroid taper and continue to taper over at
least 1 month. Based on limited data from clinical studies in
patients whose immune-related adverse reactions could not be
controlled with corticosteroid use, administration of other
systemic immunosuppressants can be considered. Resume KEYTRUDA when
the adverse reaction remains at Grade 1 or less following
corticosteroid taper. Permanently discontinue KEYTRUDA for any
Grade 3 immune-mediated adverse reaction that recurs and for any
life-threatening immune-mediated adverse reaction.
The following clinically significant, immune-mediated adverse
reactions occurred in less than 1% (unless otherwise indicated) of
1567 patients with melanoma: arthritis (1.6%), exfoliative
dermatitis, bullous pemphigoid, uveitis, myositis, Guillain-Barré
syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic
anemia, and partial seizures arising in a patient with inflammatory
foci in brain parenchyma. The following clinically significant,
immune-mediated adverse reactions occurred in less than 1% of 550
patients with NSCLC: rash, vasculitis, hemolytic anemia, serum
sickness, and myasthenia gravis.
Severe and life-threatening infusion-related reactions have been
reported in 3 (0.1%) of 2117 patients. Monitor patients for signs
and symptoms of infusion related reactions including rigors,
chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia,
and fever. For Grade 3 or 4 reactions, stop infusion and
permanently discontinue KEYTRUDA .
Based on its mechanism of action, KEYTRUDA can cause fetal harm
when administered to a pregnant woman. If used during pregnancy, or
if the patient becomes pregnant during treatment, apprise the
patient of the potential hazard to a fetus. Advise females of
reproductive potential to use highly effective contraception during
treatment and for 4 months after the last dose of KEYTRUDA.
In Trial 6, 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 (pembrolizumab) 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 Trial 2, 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 maculo-papular 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 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%).
No formal pharmacokinetic drug interaction studies have been
conducted with KEYTRUDA.
It is not known whether KEYTRUDA is excreted in human milk.
Because many drugs are excreted in human milk, instruct women to
discontinue nursing during treatment with KEYTRUDA and for 4 months
after the final dose.
Safety and effectiveness of KEYTRUDA have not been established
in pediatric patients.
Our Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck
Oncology, helping people fight cancer is our passion and supporting
accessibility to our cancer medicines is our commitment. Our focus
is on pursuing research in immuno-oncology and we are accelerating
every step in the journey – from lab to clinic – to potentially
bring new hope to people with cancer.
As part of our focus on cancer, Merck is committed to exploring
the potential of immuno-oncology with one of the fastest-growing
development programs in the industry. We are currently executing an
expansive research program that includes more than 270 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
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in new product development, including obtaining regulatory
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dependence on the effectiveness of the company’s patents and other
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The company undertakes no obligation to publicly update any
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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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