New KEYTRUDA® (pembrolizumab) Data at 2016 ASCO Annual Meeting Includes Three-Year Overall Survival Data in Melanoma and Updated Overall Survival Data in Non-Small Cell Lung Cancer As Well As Updated Findings in Head and Neck Cancer
May 16, 2016 7:00 am ET
Data at ASCO Evaluates KEYTRUDA As Single Agent and in Novel Combinations in More Than 15 Different Cancers, Including Several New Tumors
KENILWORTH, N.J.–(BUSINESS WIRE)–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,
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
(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.
(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.
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
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
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
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
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 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.
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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
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solutions. We also demonstrate our commitment to increasing access to
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For more information, visit www.merck.com
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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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