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December 5, 2016 7:30 pm ET

Data from Pivotal KEYNOTE-087 Trial Show Overall Response Rate (ORR) of 69.0 Percent and Complete Remission Rate (CRR) of 22.4 Percent

With More than Two Years of Follow-up, Findings from KEYNOTE-013 Show ORR of 58 Percent and CRR of 19 Percent with Responses of 12 Months or Greater in 70 Percent of Responding Patients

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today updated findings evaluating KEYTRUDA^®
(pembrolizumab), the company’s anti-PD-1 therapy, in two trials of
patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
In the KEYNOTE-087 and KEYNOTE-013 trials, KEYTRUDA demonstrated overall
response rates (ORR) of 69.0 percent and 58 percent, respectively.
KEYNOTE-013, which had a median follow up of 29 months, showed responses
of 12 months or greater in 70 percent of patients who responded to
therapy. These findings will be presented today at the 58^th
Annual Meeting of the American Society of Hematology (ASH).
Additionally, data from these trials supported the recently announced
regulatory filing with the U.S. Food and Drug Administration.

“As the data mature from these two studies, we continue to be encouraged
by the response rates, including complete remission and durable
responses, in patients with relapsed or refractory classical Hodgkin
lymphoma,” said Dr. Roger Dansey, senior vice president and therapeutic
area head, oncology late-stage development, Merck Research Laboratories.

The KEYTRUDA clinical development program includes more than 30 tumor
types in nearly 400 clinical trials, including more than 200 trials that
combine KEYTRUDA with other cancer treatments. For hematologic
malignancies specifically, Merck is conducting broad immuno-oncology
research assessing the role of monotherapy and combination regimens with
KEYTRUDA (pembrolizumab). The hematology program includes nearly 40
ongoing studies – including company sponsored, investigator sponsored
and collaborative studies; several of these are registration-enabling
trials.

“When patients with classical Hodgkin lymphoma do not respond to
standard of care chemotherapy or autologous stem cell transplantation,
the cancer is difficult to successfully treat. For these patients, who
are often in their 20s and 30s, the need to identify new treatment
options is urgent,” said Dr. Craig Moskowitz, clinical director,
division of hematologic oncology, Memorial Sloan Kettering Cancer
Center. “These data are promising and show that pembrolizumab may
provide meaningful clinical benefit to patients with this disease.”

Results from KEYNOTE-087

Results from the KEYNOTE-087 trial will be presented in an oral
presentation by Dr. Moskowitz at 5 p.m. PST (Location: San Diego
Convention Center, Room 6B) (Abstract #1107).

KEYNOTE-087 is a multicenter, open-label, multi-cohort,
activity-estimating phase 2 trial evaluating KEYTRUDA (200 mg fixed dose
every three weeks) monotherapy in patients with relapsed or refractory
cHL across three cohorts. The primary endpoints include overall safety,
tolerability, and ORR (per blinded independent central review, BICR);
secondary endpoints include ORR (per investigator review), duration of
response (DOR), progression-free survival (PFS) and overall survival
(OS). The patient cohorts are intended to assess the outcome measures
in: patients whose disease progressed following an autologous stem cell
transplantation and subsequent treatment with brentuximab vedotin, an
antibody drug conjugate (Cohort 1); patients who failed salvage
chemotherapy and were ineligible for a transplant and whose disease
progressed following treatment with brentuximab vedotin (Cohort 2); and
patients whose disease progressed after transplant and who did not
receive brentuximab vedotin after transplant (Cohort 3).

Across all 210 enrolled patients, the ORR was 69.0 percent
(n=145; 95% CI, 62.3-75.2) by BICR, and the complete remission rate was
22.4 percent (n=47; 95% CI, 16.9-28.6). Across all cohorts, 93 percent
of patients experienced a decrease in tumor burden (n=192).

By cohort, the data showed:

• In Cohort 1, (n=69), ORR was 73.9 percent (n=51; 95% CI, 61.9-83.7) –
  with complete remissions in 21.7 percent (n=15; 95% CI, 12.7-33.3) and
  partial remissions in 52.2 percent (n=36; 95% CI, 39.8-64.4) of
  patients. An additional 15.9 percent of patients had stable disease
  (n=11; 95% CI, 8.2-26.7) and 7.2 percent of patients had progressive
  disease (n=5; 95% CI, 2.4-16.1). Additionally, 82.2 percent of
  responding patients had a response of six months or greater.
• In Cohort 2 (n=81), ORR was 64.2 percent (n=52; 95% CI, 52.8-74.6) –
  with complete remissions in 24.7 percent (n=20; 95% CI, 15.8-35.5) and
  partial remissions in 39.5 percent (n=32; 95% CI, 28.8-51.0) of
  patients. An additional 12.3 percent of patients had stable disease
  (n=10; 95% CI, 6.1-21.5) and 21.0 percent of patients had progressive
  disease (n=17; 95% CI, 12.7-31.5). Additionally, 70 percent of
  responding patients had a response of six months or greater.
• In Cohort 3 (n=60), ORR was 70.0 percent (n=42; 95% CI, 56.8-81.2) –
  with complete remissions in 20.0 percent (n=12; 95% CI, 10.8-32.3) and
  partial remissions in 50.0 percent (n=30; 95% CI, 36.8-63.2) of
  patients. An additional 16.7 percent of patients had stable disease
  (n=10; 95% CI, 8.3-28.5) and 13.3 percent of patients had progressive
  disease (n=8; 95% CI, 5.9-24.6). Additionally, 75.6 percent of
  responding patients had a response of six months or greater.

Results also included an analysis of patients with primary refractory
disease (n=73), defined as failure to achieve complete or partial
response to first-line treatment. In this patient population, the ORR
(per BICR) was 79.5 percent (n=58; 95% CI, 68.4-88.0). Additionally, an
ORR of 67.8 percent (95% CI, 59.6-75.3) was reported in patients who
relapsed after three or more lines of prior therapy (n=99/146).

The safety profile of KEYTRUDA (pembrolizumab) was consistent with that
observed in previously reported studies. The most common
treatment-related adverse events were hypothyroidism (12.4%), pyrexia
(10.5%), fatigue (9.0%), rash (7.6%), diarrhea (7.1%), headache (6.2%),
nausea (5.7%), cough (5.7%) and neutropenia (5.2%). The most common
grade 3 or 4 treatment-related adverse events were neutropenia (2.4%),
diarrhea (1.0%) and dyspnea (1.0%). Immune-mediated adverse events
included pneumonitis (2.9%), hyperthyroidism (2.9%), colitis (1.0%) and
myositis (1.0%). There were nine discontinuations because of
treatment-related adverse events and no treatment-related deaths.

Results from KEYNOTE-013

Results from the KEYNOTE-013 trial will be presented in an oral
presentation by Dr. Philippe Armand, medical oncologist, Dana-Farber
Cancer Institute at 5:15 p.m. PST (Location: San Diego Convention
Center, Room 6B) (Abstract #1108).

KEYNOTE-013 is an ongoing, multicenter, non-randomized, phase 1b trial
of approximately 200 patients evaluating the safety, tolerability, and
efficacy of KEYTRUDA (pembrolizumab) monotherapy in patients with blood
cancers, including myelodysplastic syndromes, multiple myeloma,
classical Hodgkin lymphoma, mediastinal large B cell lymphoma and
certain other non-Hodgkin’s lymphoma (or lymphomata). The primary
endpoints of the study include overall safety, tolerability, and
complete remission rate (as measured by International Harmonization
Project Response Criteria); secondary endpoints include ORR, DOR, PFS,
and OS.

Data from a cohort of the study evaluated KEYTRUDA monotherapy at 10
mg/kg every two weeks in patients with relapsed or refractory cHL who
had progressed on or after treatment with brentuximab vedotin after
failure of autologous stem cell transplant, or who were
transplant-ineligible. Response was assessed at week 12 and every 8
weeks thereafter according to the International Harmonization Project
2007 criteria.

Across all 31 patients enrolled in the KEYNOTE-013 classical Hodgkin
lymphoma cohort, the ORR was 58 percent (n=18; 95% CI, 39-76) by BICR,
and the complete remission rate was 19 percent (n=6; 95% CI, 8-38).
Thirty-nine percent of patients achieved partial remission (n=12; 95%
CI, 22-58) and 23 percent had stable disease (n=7; 95% CI, 10-41). The
median duration of response was not yet reached (range 0.0+ to 26.1+
months) and 70 percent of responding patients had a response of 12
months or greater. The median duration of follow-up was 29 months.

Measured by BICR, median PFS was 11.4 months (4.9-27.8). The six-month
PFS rate was 66 percent and the 12-month rate was 48 percent. Median OS
was not reached. Six-month and 12-month OS rates were 100 percent and 87
percent, respectively.

The safety profile of KEYTRUDA was consistent with that observed in
previously reported studies. The most common treatment-related adverse
events were diarrhea (19%), hypothyroidism (13%), pneumonitis (13%),
nausea (13%), fatigue (10%) and dyspnea (10%). The most common grade 3
or 4 treatment-related adverse events were colitis (3%), axillary pain
(3%), AST increased (3%), joint swelling (3%), nephrotic syndrome back
pain (3%) and dyspnea (3%). Adverse events leading to discontinuation
were nephrotic syndrome (grade 3), interstitial lung disease (grade 2)
and pneumonitis (grade 2). There were no treatment-related deaths.

About Hodgkin Lymphoma

Hodgkin lymphoma is a type of lymphoma that develops in the white blood
cells, called lymphocytes, which are part of the immune system. Hodgkin
lymphoma can start almost anywhere – most often in lymph nodes in the
upper part of the body, with the most common sites being in the chest,
neck or under the arms. In 2016, it is estimated that more than 8,500
people will be diagnosed with Hodgkin lymphoma in the U.S.; cHL accounts
for about 95 percent of all cases of Hodgkin lymphoma in developed
countries.

About KEYTRUDA

^®

(pembrolizumab)

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 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 use vial.

KEYTRUDA Indications and Dosing

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or
metastatic melanoma at a dose of 2 mg/kg every three weeks until disease
progression or unacceptable toxicity.

Lung Cancer

KEYTRUDA 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 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.

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.

Head and Neck Cancer

KEYTRUDA (pembrolizumab) 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.

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
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 (pembrolizumab) 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. The incidence of new or worsening
hypothyroidism was higher in patients with HNSCC occurring in 28 (15%)
of 192 patients with HNSCC, including Grade 3 (0.5%) 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 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. 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.

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

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 KEYNOTE-006, 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 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 KEYNOTE-002, 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 maculopapular 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 8% of 682 patients
with metastatic NSCLC. The most common adverse event resulting in
permanent discontinuation of KEYTRUDA (pembrolizumab) was pneumonitis
(1.8%). Adverse reactions leading to interruption of KEYTRUDA occurred
in 23% of patients; the most common (≥1%) were diarrhea (1%), fatigue
(1.3%), pneumonia (1%), liver enzyme elevation (1.2%), decreased
appetite (1.3%), and pneumonitis (1%). The most common adverse reactions
(occurring in at least 20% of patients and at a higher incidence than
with docetaxel) were decreased appetite (25% vs 23%), dyspnea (23% vs
20%), and nausea (20% vs 18%).

KEYTRUDA was discontinued due to adverse reactions in 17% of 192
patients with HNSCC. Serious adverse reactions occurred in 45% of
patients. The most frequent serious adverse reactions reported in at
least 2% of patients were pneumonia, dyspnea, confusional state,
vomiting, pleural effusion, and respiratory failure. The most common
adverse reactions (reported in at least 20% of patients) were fatigue,
decreased appetite, and dyspnea. Adverse reactions occurring in patients
with HNSCC were generally similar to those occurring in patients with
melanoma or NSCLC, with the exception of increased incidences of facial
edema (10% all Grades; 2.1% Grades 3 or 4) and new or worsening
hypothyroidism.

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, 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 nearly 400 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
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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
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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
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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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