Data in Nine Difficult-to-Treat Cancers from Merck’s KEYTRUDA® (pembrolizumab) Development Program to be Presented at European Cancer Congress 2015, Including Data in Four New Cancer Types: …
September 21, 2015 7:00 am ET
…Nasopharyngeal Carcinoma, Anal Cancer, Merkel Cell Carcinoma and Biliary Tract Cancer
Data to Include First-Time Findings on the Potential Importance of PD-L2 Expression in Predicting Patient Responsiveness to Anti-PD-1 Therapy
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today that new data investigating the anti-tumor activity of
KEYTRUDA® (pembrolizumab) across a broad range of advanced
cancers will be presented at this year’s European Cancer Congress (ECC)
in Vienna, Austria, Sept. 25-29. In total, 15 KEYTRUDA-related abstracts
across nine difficult-to-treat cancers will be presented at this year’s
ECC – including four late-breaking oral presentations. First-time data
looking at PD-L2 expression in multiple tumors to assess the potential
value of this biomarker in patient responsiveness to anti PD-1 therapies
will also be presented. With these and other presentations, data on the
potential role of KEYTRUDA will have been presented in more than 17
Studies accepted into this year’s ECC program also include the
investigation of KEYTRUDA monotherapy in anal cancer, biliary tract
cancer, colorectal cancer, Merkel cell carcinoma (a type of skin
cancer), nasopharyngeal carcinoma (a type of head and neck cancer), and
non-small cell lung cancer (NSCLC), as well as a study evaluating
KEYTRUDA in combination with another immunotherapy treatment in melanoma.
“As we continue to build our growing body of clinical data expanding our
understanding of the potential for KEYTRUDA, we are also committed to
identifying factors that may help us determine which patients are most
likely to respond best to an individual medicine or approach,” said Dr.
Roger Dansey, senior vice president and therapeutic area head, oncology
late-stage development, Merck Research Laboratories. “The initial data
we are seeing with regard to PD-L2 expression now point to the potential
relevance of dual PD-L1 and PD-L2 blockade in anti-PD-1 therapy for
KEYTRUDA, Merck’s anti-PD-1 therapy, is a humanized monoclonal antibody
that blocks the interaction between PD-1 and its ligands, PD-L1 and
PD-L2. By binding to the PD-1 receptor and blocking the interaction with
the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated
inhibition of the immune response, including the anti-tumor immune
response. The KEYTRUDA clinical development program has rapidly expanded
to encompass more than 30 tumor types in more than 130 clinical trials,
of which more than 70 trials combine KEYTRUDA with other cancer
treatments. Registration-enabling trials of KEYTRUDA monotherapy are
currently enrolling patients in melanoma, NSCLC, head and neck cancer,
bladder cancer, gastric cancer, colorectal cancer, and Hodgkin Lymphoma,
with further trials in planning for other cancers.
“At Merck, we are rapidly expanding our clinical studies for KEYTRUDA in
a wide range of cancers with the goal of potentially providing cancer
patients with promising new options, and helping physicians identify
which approaches may be best for an individual patient,” said Dr. Roy
Baynes, senior vice president and head of global clinical development,
Merck Research Laboratories. “We look forward to sharing these new data
at the European Cancer Congress as we continue to focus on bringing the
breakthrough science of immuno-oncology to as many patients as possible.”
Merck’s Immuno-Oncology Data at European Cancer Congress 2015
A listing of the KEYTRUDA late-breaker, oral and poster sessions are
Late-Breaker Oral Presentations
(Abstract #18LBA) PD-L2 expression in human tumors: relevance to
anti-PD-1 therapy in cancer. J. Yearley. Sunday, Sept. 27, 10:05 AM
CEST. Location: Hall A1.
(Abstract #24LBA) Safety data from the phase 1b part of the
MASTERKEY-265 study combining talimogene laherparepvec (T-VEC) and
pembrolizumab for unresectable stage IIIB-IV melanoma. G. Long.
Sunday, Sept. 27, 12:00 PM CEST. Location: Hall A2.
(Abstract #33LBA) Efficacy and safety of pembrolizumab (pembro;
MK-3475) for patients (pts) with previously treated advanced non-small
cell lung cancer (NSCLC) Enrolled in KEYNOTE-001. J.C. Soria. Monday,
Sept. 28, 10:50 AM CEST. Location: Strauss.
(Abstract #22LBA) Activity of PD-1 blockade with pembrolizumab as
first systemic therapy in patients with advanced Merkel cell
carcinoma. P. Nghiem. Sunday, Sept. 27, 11:30 AM CEST. Location: Hall
(Abstract #2801) Antitumor activity and safety of pembrolizumab in
patients with PD-L1–positive nasopharyngeal carcinoma: Interim results
from a phase 1b study. C. Hsu. Saturday, Sept. 26, 10:45 CEST.
Location: Hall C1.
(Abstract #500) Pembrolizumab (MK-3475) for PD-L1–positive squamous
cell carcinoma (SCC) of the anal canal: Preliminary safety and
efficacy results from KEYNOTE-028. P. Ott. Sunday, Sept. 27, 5:05 PM
CEST. Location: Hall D1.
(Abstract #502) Pembrolizumab (MK-3475) for patients (pts) with
advanced colorectal carcinoma (CRC): Preliminary results from
KEYNOTE-028. B. O’Neil. Sunday, Sept. 27, 5:35 PM CEST. Location: Hall
(Abstract #507) Evaluation of patients with progressive metastatic
head and neck cancer treated with PD-1 inhibition with pembrolizumab
and radiation therapy: Assessment of local and systemic effects. T.Y.
Seiwert. Saturday, Sept. 26, 4:45 PM-6:45 PM CEST. Location: Hall C.
(Abstract #523) Initial clinical experience with pembrolizumab in
metastatic heavily pre-treated patients with solid cancers in a single
institution. R. Leibowitz-Amit. Saturday, Sept. 26, 4:45 PM-6:45 PM
CEST. Location: Hall C.
(Abstract #525) Safety and efficacy of pembrolizumab (MK-3475) in
patients (pts) with advanced biliary tract cancer: Interim results of
KEYNOTE-028. Y.J. Bang. Saturday, Sept. 26, 4:45 PM-6:45 PM CEST (5:15
PM-6:15 PM CEST spotlight session). Location: Hall C.
(Abstract #2860) Correlation between plasma Epstein-Barr virus DNA and
clinical response to pembrolizumab in patients with advanced or
metastatic nasopharyngeal carcinoma. H.F. Kao. Sunday, Sept. 27, 9:15
AM-11:15 AM CEST. Location: Hall C.
(Abstract #2866) Antitumor activity of the anti-PD-1 antibody
pembrolizumab in subgroups of patients with recurrent/metastatic head
and neck squamous cell carcinoma (R/M HNSCC): Exploratory analyses
from KEYNOTE-012. L. Chow. Sunday, Sept. 27, 9:15 AM-11:15 AM CEST.
Location: Hall C.
(Abstract #3325) Safety and efficacy of pembrolizumab (MK-3475) for
Japanese patients (pts) with advanced melanoma: Preliminary results
from KEYNOTE-041 Phase 1b study. K. Yokota. Sunday, Sept. 27, 4:45
PM-6:45 PM CEST. Location: Hall C.
(Abstract #3344) Relationship between pembrolizumab exposure and
efficacy/safety in 1016 patients (pts) with advanced or metastatic
melanoma. S.P. Kang. Sunday, Sept. 27, 4:45 PM-6:45 PM CEST. Location:
(Abstract #2622) A Phase I/II study to assess the safety and efficacy
of pazopanib (paz) and pembrolizumab (pembro) in patients (pts) with
advanced renal cell carcinoma (aRCC). D.F. McDermott. Monday, Sept.
28, 4:45 PM-6:45 PM CEST. Location: Hall C.
For more information, including a complete list of abstract titles,
please visit the European Cancer Congress website at http://www.europeancancercongress.org/Scientific-Programme/Searchable-Programme#anchorScpr.
About KEYTRUDA® (pembrolizumab)
KEYTRUDA is a humanized monoclonal antibody that blocks the interaction
between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1
receptor and blocking the interaction with the receptor ligands,
KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune
response, including the anti-tumor immune response. KEYTRUDA is
indicated for the treatment of patients with unresectable or metastatic
melanoma and disease progression following ipilimumab and, if BRAF V600
mutation positive, a BRAF inhibitor. 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
Selected Important Safety Information for KEYTRUDA
Pneumonitis occurred in 12 (2.9%) of 411 patients, including Grade 2 or
3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively, receiving
KEYTRUDA. 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
Colitis (including microscopic colitis) occurred in 4 (1%) of 411
patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%)
patients, respectively, receiving KEYTRUDA. 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.
Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411
patients, including a Grade 4 case in 1 (0.2%) patient, receiving
KEYTRUDA. 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 2 (0.5%) of 411 patients, including a Grade 2
case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving
KEYTRUDA. Monitor patients for signs and symptoms of hypophysitis
(including hypopituitarism and adrenal insufficiency). Administer
corticosteroids for Grade 2 or greater hypophysitis. Withhold KEYTRUDA
for Grade 2; withhold or discontinue for Grade 3; and permanently
discontinue KEYTRUDA for Grade 4 hypophysitis.
Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including Grade 2
or 3 cases in 2 (0.5%) and 1 (0.2%) patients, respectively, receiving
KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients,
including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA.
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 corticosteroids for Grade 3 or greater hyperthyroidism.
Withhold KEYTRUDA for Grade 3; permanently discontinue KEYTRUDA for
Grade 4 hyperthyroidism. Isolated hypothyroidism may be managed with
replacement therapy without treatment interruption and without
Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred
in patients receiving KEYTRUDA. Monitor patients for hyperglycemia and
other signs and symptoms of diabetes. Administer insulin for type 1
diabetes, and withhold KEYTRUDA in cases of severe hyperglycemia until
metabolic control is achieved.
Nephritis occurred in 3 (0.7%) patients, consisting of one case of Grade
2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis
with renal failure (0.5%), one Grade 3 and one Grade 4. 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.
The following clinically significant immune-mediated adverse reactions
occurred in patients treated with KEYTRUDA: exfoliative dermatitis,
uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, partial
seizures arising in a patient with inflammatory foci in brain
parenchyma, severe dermatitis including bullous pemphigoid, myasthenic
syndrome, optic neuritis, and rhabdomyolysis.
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 of the adverse reaction to Grade 1 or
less, initiate corticosteroid taper and continue to taper over at least
1 month. Restart KEYTRUDA if the adverse reaction remains at Grade 1 or
less. Permanently discontinue KEYTRUDA for any severe or Grade 3
immune-mediated adverse reaction that recurs and for any
life-threatening immune-mediated adverse reaction. [W&P, 5.6, p.6]
Infusion-related reactions, including severe and life-threatening
reactions, have occurred in patients receiving KEYTRUDA. Monitor
patients for signs and symptoms of infusion-related reactions including
rigors, chills, wheezing, pruritus, flushing, rash, hypotension,
hypoxemia, and fever. For severe or life-threatening reactions, stop
infusion and permanently discontinue KEYTRUDA.
Based on its mechanism of action, KEYTRUDA may 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 was discontinued for adverse reactions in 9% of 411 patients.
Adverse reactions, reported in at least two patients, that led to
discontinuation of KEYTRUDA were: pneumonitis, renal failure, and pain.
Serious adverse reactions occurred in 36% of patients. The most frequent
serious adverse reactions, reported in 2% or more of patients, were
renal failure, dyspnea, pneumonia, and cellulitis.
The most common adverse reactions (reported in at least 20% of patients)
were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash
(29%), decreased appetite (26%), constipation (21%), arthralgia (20%),
and diarrhea (20%).
The recommended dose of KEYTRUDA is 2 mg/kg administered as an
intravenous infusion over 30 minutes every three weeks until disease
progression or unacceptable toxicity. 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. Safety and effectiveness of KEYTRUDA have not
been established in pediatric patients.
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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 the Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf
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