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June 3, 2017 7:30 am ET

First-Time Findings from KEYNOTE-164 and KEYNOTE-158, to Be Presented at ASCO, Further Support the Utility of MSI-H and dMMR as Predictive Biomarkers for Tumor-Agnostic Treatment Approach with KEYTRUDA

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced the first presentation of findings from KEYNOTE-164 and
KEYNOTE-158, two phase 2 studies evaluating KEYTRUDA^® (pembrolizumab),
the company’s anti-PD-1 therapy, in patients with advanced
microsatellite instability-high (MSI-H) or mismatch repair deficient
(dMMR) solid tumors. The studies showed overall response rates (ORR),
regardless of histology, with ORR between 28 percent (95% CI, 17-41) and
38 percent (95% CI, 27-49) across patients with MSI-H/dMMR colorectal
cancer (CRC) and other advanced MSI-H/dMMR solid tumors, respectively.
These findings will be presented on Monday, June 5 at the 2017 American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract
#3071).

“These important data build on the research to date showing clinically
meaningful responses with pembrolizumab (KEYTRUDA) monotherapy across a
wide range of tumors with MSI-H or dMMR status in patients whose disease
is locally advanced or metastatic,” said Dr. Luis A. Diaz, Jr., head of
the division of solid tumor oncology, Memorial Sloan Kettering Cancer
Center. “Moreover, these data confirm the initial findings we made
demonstrating the value of MSI-H or dMMR tumor status as a predictive
biomarker for KEYTRUDA for these difficult-to-treat cancers.”

“These data exemplify our commitment to advancing the use of biomarkers
to help identify patients most likely to benefit from KEYTRUDA,” said
Dr. Roger Dansey, senior vice president and therapeutic area head,
oncology late-stage development, Merck Research Laboratories.

The KEYTRUDA (pembrolizumab) clinical development program includes more
than 30 tumor types in more than 500 clinical trials, including more
than 300 trials that combine KEYTRUDA with other cancer treatments.
Merck’s immuno-oncology clinical development program includes multiple
registration-enabling studies investigating KEYTRUDA as a monotherapy in
MSI-H and dMMR cancers.

Key Findings from KEYNOTE-164 and KEYNOTE-158 Studies

KEYNOTE-164 and KEYNOTE-158 are ongoing global, open-label,
non-randomized, multi-cohort, multi-center phase 2 studies evaluating
KEYTRUDA (200 mg every three weeks) in patients with advanced MSI-H or
dMMR solid tumors. KEYNOTE-164 is enrolling patients with previously
treated, unresectable locally advanced or metastatic MSI-H or dMMR CRC
who received two or more prior therapies that included fluoropyrimidine,
irinotecan, and oxaliplatin. KEYNOTE-158 is enrolling patients with any
advanced MSI-H solid tumor, with the exception of CRC, who had received
one or more prior therapies. MSI-H or dMMR tumor status is determined
using local laboratory-developed, polymerase chain reaction (PCR) tests
for MSI-H status or immunohistochemistry (IHC) tests for dMMR. Tumor
response is assessed every nine weeks per Response Evaluation Criteria
in Solid Tumors (RECIST) v1.1 by independent, central, blinded
radiographic review. The primary endpoint of the studies is ORR;
secondary endpoints include duration of response, progression-free
survival (PFS), overall survival (OS) and safety.

Of the 61 patients with advanced CRC who were enrolled in KEYNOTE-164
(as of Feb. 10, 2017), the ORR was 28 percent (n=17/61) (95% CI, 17-41)
– with zero complete responses and 17 partial responses; fourteen had
stable disease and 28 had progressive disease – for an overall disease
control rate of 51 percent (n=31/61) (95% CI, 38-64). Median time to
response was four months (range: 2-10).

Of the 77 patients with any advanced solid tumor, excluding CRC and with
≥27 weeks of follow-up, who were enrolled in KEYNOTE-158 (as of Jan. 27,
2017), the ORR was 38 percent (n=29/77) (95% CI, 27-49) – with two
complete responses and 27 partial responses; sixteen had stable disease
and 24 had progressive disease – for an overall disease control rate of
58 percent (n=45/77) (95% CI, 47-70). Median time to response was 2
months (range: 1-4).

For the PFS analysis, in patients with CRC the estimated 6-month rate
was 43 percent and the 12-month rate was 34 percent – with a median PFS
of 2.3 months (95% CI, 2.1-8.1); in patients with any advanced solid
tumor, excluding CRC, the estimated 6-month rate was 45 percent – with a
median PFS of 4.3 months (95% CI, 3.1-not reached). For the OS analysis,
in patients with CRC the estimated 6-month rate was 87 percent and the
12-month rate was 72 percent – with a median OS not yet reached; in
patients with any advanced solid tumor, excluding CRC, the estimated
6-month rate was 73 percent – with a median OS not yet reached (95% CI,
9.2-not reached). Median follow-up was 13.2 months (range: 0-17) and 6.1
months (range: 1-12), respectively. At the time of analysis, median
duration of response had not been reached in either study (range:
2.9+-12.5+ and range: 2.4+-9.2+, respectively).

The safety profile of KEYTRUDA (pembrolizumab) was consistent with that
observed in previously reported studies. In patients with CRC, the
treatment-related adverse events observed to date (any grade occurring
in 10% or more of patients) were arthralgia (n=10), nausea (n=9),
diarrhea (n=8), asthenia (n=7), pruritus (n=7) and fatigue (n=6); these
included Grade 3-4 treatment-related fatigue (n=2) and asthenia (n=1).
Immune-mediated adverse events of Grade 3-4 were pancreatitis (n=3),
hepatitis (n=1) and severe skin toxicity (n=1). There were no
treatment-related deaths.

In patients with any advanced solid tumor, excluding CRC, the
treatment-related adverse events observed to date (any grade occurring
in 10% or more of patients) were fatigue (n=8), pruritus (n=7), asthenia
(n=7), diarrhea (n=7), nausea (n=6) and arthralgia (n=2); these include
Grade 3-4 asthenia (n=1) and diarrhea (n=1). Immune-mediated adverse
events of Grade 3-4 toxicity were severe skin toxicity (n=2),
hyperthyroidism (n=1), pneumonitis (n=1), fulminant type 1 diabetes
mellitus (n=1) and Guillain-Barre Syndrome (n=1). There was one death
attributed to treatment-related pneumonia by investigator.

About Microsatellite Instability and DNA Mismatch Repair

Microsatellites are short repetitive sequences of DNA found throughout
the genome. Microsatellite instability – or MSI – is caused by a
deficiency in the cell’s ability to repair errors in the DNA sequence
(DNA mismatch repair) that occur during cell division, leading to a
characteristic change in microsatellite repeats. MSI is detected
indirectly by demonstrating absence of expression of mismatch repair
proteins by IHC, or more directly by PCR-based amplification of specific
microsatellite repeats. MSI-H (microsatellite instability-high) is
already an established biomarker in certain types of cancer. Patients
determined to have mismatch repair deficiency (dMMR) are biologically
the same population as those with MSI-H status. MSI-H/dMMR occurs in a
variety of cancers across all stages.

About KEYTRUDA

^®

(pembrolizumab) Injection

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 benefiting
from treatment with KEYTRUDA, including the exploration of several
different biomarkers across a broad range of tumors.

KEYTRUDA is administered as an intravenous infusion over 30 minutes
every three weeks for the approved indications. KEYTRUDA for injection
is supplied in a 100 mg single-dose vial.

KEYTRUDA (pembrolizumab) Indications and Dosing

Melanoma

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.

Lung Cancer

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
aberrations.

KEYTRUDA, 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 (pembrolizumab), 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.

Urothelial Carcinoma

KEYTRUDA (pembrolizumab) is indicated for the treatment of patients with
locally advanced or metastatic urothelial carcinoma who are not eligible
for cisplatin-containing chemotherapy. This indication is approved under
accelerated approval based on tumor response rate and duration of
response. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the confirmatory
trials.

KEYTRUDA is also indicated for the treatment of patients with locally
advanced or metastatic urothelial carcinoma who have disease progression
during or following platinum-containing chemotherapy or within 12 months
of neoadjuvant or adjuvant treatment with platinum-containing
chemotherapy.

In locally advanced or metastatic urothelial carcinoma, 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.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients
with unresectable or metastatic microsatellite instability-high (MSI-H)
or mismatch repair deficient (dMMR)

• solid tumors that have progressed following prior treatment and who
  have no satisfactory alternative treatment options, or
• colorectal cancer that has progressed following treatment with
  fluoropyrimidine, oxaliplatin, and irinotecan.

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. The safety and
effectiveness of KEYTRUDA in pediatric patients with MSI-H central
nervous system cancers have not been established.

In adult patients with MSI-H cancer, 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. In
pediatric patients with MSI-H cancer, 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

^®
 (pembrolizumab)

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
(pembrolizumab) 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
discontinue KEYTRUDA.

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 for Grade 3 or 4 hyperthyroidism.

KEYTRUDA (pembrolizumab) 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. These immune-mediated reactions may occur in any organ
system. 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 the benefit of treatment
with KEYTRUDA vs the risk of possible organ rejection in these patients.

KEYTRUDA can cause severe or life-threatening infusion-related
reactions, including hypersensitivity and anaphylaxis, 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 (pembrolizumab).

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.

The most common adverse reactions (reported in ≥20% of patients) were
fatigue, pruritis, diarrhea, decreased appetite, rash, pyrexia, cough,
dyspnea, musculoskeletal pain, constipation, and nausea.

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.

There is limited experience in pediatric patients. In a study, 40
pediatric patients (16 children aged 2 years to younger than 12 years
and 24 adolescents ages 12 years to 18 years) with advanced melanoma,
lymphoma, or PD-L1–positive advanced, relapsed, or refractory solid
tumors, were administered KEYTRUDA 2 mg/kg every 3 weeks. Patients
received KEYTRUDA for a median of 3 doses (range 1-17 doses), with 34
patients (85%) receiving KEYTRUDA for 2 doses or more. The safety
profile in these pediatric patients was similar to that seen in adults
treated with KEYTRUDA. Toxicities that occurred at a higher rate (≥15%
difference) in these patients when compared to adults under 65 years of
age were fatigue (45%), vomiting (38%), abdominal pain (28%),
hypertransaminasemia (28%), and hyponatremia (18%).

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.

About Merck

For more than a century, Merck, a leading global biopharmaceutical
company known as MSD outside of the United States and Canada, has been
inventing for life, bringing forward medicines and vaccines for many of
the world’s most challenging diseases. 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. 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,
visit www.merck.com
and connect with us on Twitter, Facebook, Instagram,
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and LinkedIn.

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“company”) includes “forward-looking statements” within the meaning of
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Reform Act of 1995. These statements are based upon the current beliefs
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respect to pipeline products that the products will receive the
necessary regulatory approvals or that they will prove to be
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The company undertakes no obligation to publicly update any
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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

.

Merck
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