Findings Across a Range of Hematological Cancers Add to The Growing Breadth of KEYTRUDA® (pembrolizumab) Data
December 8, 2015 8:00 am ET
New Findings Presented at 57th American Society of Hematology Annual Meeting in Difficult-to-Treat Blood Cancers Including Multiple Myeloma and Three Types of Lymphoma
Broad KEYTRUDA Development Program in Hematology Includes Four Registrational Studies
Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today that new study findings investigating the use of KEYTRUDA®
(pembrolizumab), the company’s anti-PD-1 therapy, across a range of
hematological cancers were presented at the 57th American
Society of Hematology (ASH) Annual Meeting. New and updated data were
presented that demonstrate a potential role for KEYTRUDA in multiple
myeloma, Hodgkin lymphoma, B-cell lymphoma, and Richter’s transformation
in chronic lymphocytic leukemia.
“As part of our commitment to helping people with cancer, Merck is
leading a broad immuno-oncology clinical program to evaluate the role of
KEYTRUDA across several types of blood cancer,” said Roger Dansey, M.D.,
senior vice president and therapeutic area head, oncology late-stage
development, Merck Research Laboratories. “Despite the numerous advances
in the treatment of blood cancers, there remains a significant unmet
medical need. The findings presented at ASH are encouraging, and
reinforce the potential for KEYTRUDA in the treatment of these types of
KEYTRUDA data presented at ASH included five presentations, with
first-time findings in multiple myeloma and updated findings in
classical Hodgkin lymphoma.
(Abstract #505) Oral Presentation: Pembrolizumab in
Combination with Lenalidomide and Low-Dose Dexamethasone for
Relapsed/Refractory Multiple Myeloma (RRMM): Keynote-023. J. San
Miguel. Monday, Dec. 7, 7:00 AM EST. Location: Hall E1 (Orange County
(Abstract #584) Oral Presentation: PD-1 Blockade With
Pembrolizumab in Patients With Classical Hodgkin Lymphoma After
Brentuximab Vedotin Failure: Safety, Efficacy, and Biomarker
Assessment. P. Armand. Monday, Dec. 7, 10:45 AM EST. Location:
Hall E2 (Orange County Convention Center).
(Abstract #506) Oral Presentation: A Phase II Study
of Anti PD-1 Antibody Pembrolizumab, Pomalidomide and Dexamethasone in
Patients with Relapsed/Refractory Multiple Myeloma (RRMM). A.
Badros. Monday, Dec. 7, 7:15 AM EST. Location: Hall E1 (Orange County
(Abstract #834) Oral Presentation: PD-1 Blockade with
Pembrolizumab (MK-3475) in Relapsed/Refractory CLL including Richter
Transformation: an early efficacy report from a phase 2 trial (MC1485).
W. Ding. Monday, Dec. 7, 5:45 PM EST. Location: Valencia BC (Orange
County Convention Center).
(Abstract #3986) Poster Presentation: Phase 1b Study
of PD-1 Blockade with Pembrolizumab in Patients with
Relapsed/Refractory Primary Mediastinal Large B-Cell Lymphoma (PMBCL).
P. Zinzani. Monday, Dec. 7, 6:00 PM – 8:00 PM EST. Location: Hall A
(Orange County Convention Center).
The KEYTRUDA program currently addresses more than 30 tumor types in
more than 160 clinical trials, including more than 80 trials that
combine KEYTRUDA with other cancer treatments. Within this program,
there is a strong focus on hematological malignancies, with
approximately 20 trials evaluating KEYTRUDA in blood cancers. This
includes four registration-enabling studies in Hodgkin lymphoma and
multiple myeloma, as well as more than 15 combinations of KEYTRUDA with
other treatments for specific hematologic malignancies.
Registration-enabling trials of KEYTRUDA are also currently enrolling
patients suffering from melanoma, NSCLC, head and neck cancer, bladder
cancer, gastric cancer, colorectal cancer, esophageal cancer, and breast
cancer, with further trials in planning for other malignancies.
About Blood Cancers
In most blood cancers, also called hematological malignancies, the
normal blood cell development process is interrupted by uncontrolled
growth of an abnormal type of cancerous blood cell. These cancerous
cells prevent blood from performing many of its functions, like fighting
off infections or preventing serious bleeding. There are three main
types of blood cancer: leukemia, lymphoma and myeloma. In 2012, an
estimated 916,000 people worldwide were diagnosed and 570,000 people
died from one of the three main types of blood cancer.
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 in the United States at a dose of 2 mg/kg
administered as an intravenous infusion over 30 minutes every three
weeks 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. KEYTRUDA is
also indicated at the same dosing for the treatment of patients with
unresectable or metastatic melanoma and disease progression following
ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. These
indications are 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 these indications may be contingent upon verification and
description of clinical benefit in the confirmatory trials.
Selected Important Safety Information for KEYTRUDA®
Pneumonitis, including fatal cases, occurred in patients receiving
KEYTRUDA. Pneumonitis occurred in 12 (2.9%) of 411 melanoma patients,
including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients,
respectively, receiving KEYTRUDA. 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 in patients, 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 or recurrent Grade 2
Colitis (including microscopic colitis) occurred in 4 (1%) of 411
patients with melanoma, including Grade 2 or 3 cases in 1 (0.2%) and 2
(0.5%) patients, respectively, receiving KEYTRUDA. Colitis occurred in 4
(0.7 %) of 550 patients with NSCLC, including Grade 2 (0.2%) or 3 (0.4%)
colitis in patients 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 occurred in patients receiving KEYTRUDA. Hepatitis (including
autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients with
melanoma, 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 with melanoma,
including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each)
patient, receiving KEYTRUDA. 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 indicated. Withhold KEYTRUDA for Grade 2 and withhold or
discontinue for Grade 3 or Grade 4 hypophysitis.
Hyperthyroidism occurred in 5 (1.2%) of 411 patients with melanoma,
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 with melanoma, including a Grade 3 case in 1 (0.2%)
patient, receiving KEYTRUDA. Hyperthyroidism occurred in 10 (1.8%) of
550 patients with NSCLC, including Grade 2 (0.7%) or 3 (0.3%).
Hypothyroidism occurred in 38 (6.9%) of 550 patients with NSCLC,
including Grade 2 (5.5%) or 3 (0.2%). 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 Grade 4 hyperthyroidism.
Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred
in patients receiving KEYTRUDA. 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.
Nephritis occurred in patients receiving KEYTRUDA. Nephritis occurred in
3 (0.7%) patients with melanoma, 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.
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. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or
less following steroid taper. Permanently discontinue KEYTRUDA for any
severe or Grade 3 immune-mediated adverse reaction that recurs and for
any life-threatening immune-mediated adverse reaction.
Across clinical studies with KEYTRUDA, the following clinically
significant, immune-mediated adverse reactions have occurred: bullous
pemphigoid and Guillain-Barré syndrome. The following clinically
significant, immune-mediated adverse reactions occurred in less than 1%
of patients with melanoma treated with KEYTRUDA: exfoliative dermatitis,
uveitis, arthritis, myositis, 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
treated with KEYTRUDA: rash, vasculitis, hemolytic anemia, serum
sickness, and myasthenia gravis.
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 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.
Among the 411 patients with metastatic melanoma, 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%).
Among the 550 patients with metastatic NSCLC, KEYTRUDA was discontinued
due to adverse reactions in 14% of patients. Serious adverse reactions
occurred in 38% of patients. The most frequent serious adverse reactions
reported in 2% or more 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%),
decreased appetite (25%), dyspnea (23%), and cough (29%).
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
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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.
Pamela Eisele, 267-305-3558
Kim Hamilton, 908-391-0131
Teri Loxam, 908-740-1986
Justin Holko, 908-740-1879