Updated Data to be Presented at ESMO 2017
Congress
Incyte Corporation (Nasdaq:INCY) and Merck (NYSE:MRK), known as
MSD outside the United States and Canada, today announced updated
data from the ongoing Phase 1/2 ECHO-202 trial (KEYNOTE-037)
evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor,
in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1
therapy, in patients with advanced melanoma. Among all patients
with advanced melanoma, including treatment-naïve and
treatment-experienced, data showed an overall response rate (ORR)
of 56 percent (n=35/63) in patients treated with the combination of
epacadostat and KEYTRUDA; median progression-free survival (PFS)
was 12.4 months, with PFS rates of 65 percent at six months, 52
percent at 12 months, and 49 percent at 18 months. Results were
generally consistent across dosing schedules of epacadostat
combined with KEYTRUDA, including epacadostat 100 mg BID, the
epacadostat dose being studied in the Phase 3 ECHO-301 trial.
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These results will be presented at the European Society for
Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, in an oral
presentation on Saturday, September 9 from 3-3:15 pm CEST
(Location: Madrid Auditorium) (Abstract #1214O).
“The updated results of the ECHO-202 trial support earlier
published findings, and continue to suggest that the novel
immunotherapy combination of epacadostat plus KEYTRUDA has the
potential to offer a favorable efficacy and safety profile for the
treatment of patients with advanced melanoma,” said Omid Hamid,
M.D., Chief of Translational Research and Immuno-Oncology and
Director of Melanoma Therapeutics, The Angeles Clinic and Research
Institute, Los Angeles, California. “Data have shown that
combination immunotherapy can offer higher response rates and
improved progression-free survival. These results show that this
combination has demonstrated increased and durable response rates
and improved progression-free survival, compared to what we would
expect from KEYTRUDA alone, without sacrificing safety.”
Key Findings from the ECHO-202 (KEYNOTE-037) Melanoma
Cohort
Data at ESMO (as of June 9, 2017) show an ORR of 56 percent
among all patients with advanced melanoma treated with the
combination of epacadostat and KEYTRUDA, with a complete response
(CR) in nine patients (14%); partial response (PR) in 26 patients
(41%); and stable disease (SD) in 10 patients (16%). Data also show
a disease control rate (DCR) of 71 percent (n=45/63). Of the 35
responses to treatment, 30 were ongoing at the time of analysis;
the median duration of response was 45 weeks (range: 1+ to
121+).
ECHO-202 Overall Response Rates (ORR),
Disease Control Rates (DCR), Durability of Response (DoR),
and Progression-Free Survival (PFS) in Advanced Melanoma
Cohort
All
Patients
(N=65)
Treatment-Naïve
(all epacadostat doses)
(N=54)
Treatment-Naïve
(epacadostat 100 mg BID)
(N=39)
Per-protocol evaluable n
(%)1
n=63 n=53 n=38
ORR 35 (56)
29 (55) 22 (58) 9 CR (14)
26 PR (41)
10 SD (16)
7 CR (13)
22 PR (42)
9 SD (17)
3 CR (8)
19 PR (50)
6 SD (16)
DCR 45 (71) 38 (72) 28 (74) 18
PD or death (29)
2 not evaluable2
15 PD or death (28)
1 not evaluable2
10 PD or death (26)
1 not evaluable2
DoR
30/35 responsesongoing
Duration of response:<1+ to 121+
weeks
4/5 patientscompleting studytreatment
maintainedongoing response at lastfollow-up
25/29 responsesongoing
Duration of response:<1+ to 121+
weeks
3/4 patients completingstudy
treatmentmaintained ongoingresponse at last follow-up
20/22 responsesongoing
Duration of response:
<1+ to 81+ weeks
1/1 patient completing studytreatment
maintainedongoing response at lastfollow-up
Median PFS,
months
(90% CI)
12.4
(6.2, 23.8)
22.8
(6.2, 23.8)
Not yet reached
(4.2, NR)
PFS rate,
% (90% CI)
6-month:
65 (54, 74)
12-month:
52 (40, 63)
18-month:
49 (37, 60)
6-month:
65 (53, 75)
12-month:
52 (38, 64)
18-month:
52 (38, 64)
6-month:
64 (49, 76)
12-month:
55 (39, 69)
18-month:
55 (39, 69)
1. ≥1 post-baseline scan, or
discontinuation or death before first post-baseline scan
2. Scan data not documented in the
clinical trial database at time of data cutoff
The most common (≥10 percent) all grade treatment-related
adverse events (TRAEs) were rash (46 percent), fatigue (43
percent), pruritus (29 percent), and arthralgia (17 percent). Grade
≥3 TRAEs were observed in 20 percent of patients; the most common
were increased lipase (6 percent) and rash (5 percent). Four
patients (6 percent) discontinued for TRAEs. No treatment-related
deaths occurred. The safety profile was consistent with previously
reported Phase 1 findings, as well as the Phase 1/2 safety results
in other tumor cohorts and pooled safety data from this study. In
general, the safety profile of the combination was also consistent
with KEYTRUDA (pembrolizumab) monotherapy.
About ECHO-202 (KEYNOTE-037)
The ECHO-202 study (NCT02178722) is evaluating the safety and
efficacy of epacadostat, Incyte’s selective IDO1 enzyme inhibitor,
in combination with KEYTRUDA. Patients previously treated with
anti-PD-1 or anti-CTLA-4 therapies were excluded from this trial.
Enrollment is complete for the Phase 1 dose escalation (epacadostat
25, 50, 100 mg BID + KEYTRUDA 2 mg/kg IV Q3W and epacadostat 300 mg
BID + KEYTRUDA 200 mg IV Q3W) and Phase 1 dose expansion
(epacadostat 50, 100, and 300 mg BID + KEYTRUDA 200 mg IV Q3W)
portions of the trial. For more information about ECHO-202, visit
https://clinicaltrials.gov/ct2/show/NCT02178722.
About ECHO
The ECHO clinical trial program was established to investigate
the efficacy and safety of epacadostat as a core component of
combination therapy in oncology. Ongoing Phase 1 and Phase 2
studies are evaluating epacadostat in combination with PD-1 and
PD-L1 inhibitors in a broad range of solid tumor types as well as
hematological malignancies. ECHO-301 (NCT02752074), a Phase 3
randomized, double-blind, placebo-controlled study investigating
KEYTRUDA in combination with epacadostat or placebo for the
treatment of patients with unresectable or metastatic melanoma, is
also ongoing and fully recruited. For more information about the
ECHO clinical trial program, visit www.ECHOClinicalTrials.com.
About Epacadostat (INCB024360)
The immunosuppressive effects of indoleamine 2,3-dioxygenase 1
(IDO1) enzyme activity on the tumor microenvironment help cancer
cells evade immunosurveillance. Epacadostat is an investigational,
highly potent and selective oral inhibitor of the IDO1 enzyme. In
single-arm studies, the combination of epacadostat and immune
checkpoint inhibitors has shown proof-of-concept in patients with
unresectable or metastatic melanoma, non-small cell lung cancer,
renal cell carcinoma, squamous cell carcinoma of the head and neck
and bladder cancer. In these studies, epacadostat combined with the
CTLA-4 inhibitor ipilimumab or the PD-1 inhibitors KEYTRUDA or
nivolumab improved response rates compared with studies of the
immune checkpoint inhibitors alone.
Incyte Conference Call Information
Incyte will host an investor conference call and webcast at
17:00 CET (11:00 a.m. ET) on 9 September 2017—the call and webcast
can be accessed via the Events and Presentations tab of the
Investor section of www.incyte.com.
To access the conference call on Saturday 9 September 2017,
please dial 877-407-3042 for domestic callers or +1-201-389-0864
for international callers. When prompted, provide the conference
identification number, 13667084.
If you are unable to participate, a replay of the conference
call will be available for 30 days. The replay dial-in number for
the United States is 877-660-6853 and the dial-in number for
international callers is +1-201-612-7415. To access the replay you
will need the conference identification number, 13667084.
About KEYTRUDA® (pembrolizumab) Injection
100mg
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 (pembrolizumab) – from the largest
immuno-oncology program in the industry with more than 550 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 benefitting from treatment with KEYTRUDA,
including the exploration of several different biomarkers across a
broad range of tumors.
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, 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 (pembrolizumab) 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 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 for Grade 2; permanently discontinue
KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.
KEYTRUDA (pembrolizumab) 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. 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 (pembrolizumab) for Grade
2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.
Immune-mediated rashes, including Stevens-Johnson syndrome
(SJS), toxic epidermal necrolysis (TEN) (some cases with fatal
outcome), exfoliative dermatitis, and bullous pemphigoid can occur.
Monitor patients for suspected severe skin reactions and based on
the severity of the adverse reaction, withhold or permanently
discontinue KEYTRUDA and administer corticosteroids. For signs and
symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for
specialized care for assessment and treatment. If SJS or TEN is
confirmed, permanently discontinue KEYTRUDA.
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 (pembrolizumab) 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%), 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.
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.
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 (pembrolizumab)), 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.
KEYTRUDA monotherapy 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
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%).
When KEYTRUDA was administered in combination with carboplatin
and pemetrexed (carbo/pem), KEYTRUDA was discontinued in 10% of 59
patients. The most common adverse reaction resulting in
discontinuation of KEYTRUDA (≥2%) was acute kidney injury (3.4%).
Adverse reactions leading to interruption of KEYTRUDA occurred in
39% of patients; the most common (≥2%) were fatigue (8%),
neutrophil count decreased (8%), anemia (5%), dyspnea (3.4%), and
pneumonitis (3.4%).The most common adverse reactions (≥20%) with
KEYTRUDA compared to carbo/pem alone were fatigue (71% vs 50%),
nausea (68% vs 56%), constipation (51% vs 37%), rash (42% vs 21%),
vomiting (39% vs 27%), dyspnea (39% vs 21%), diarrhea (37% vs 23%),
decreased appetite (31% vs 23%), headache (31% vs 16%), cough (24%
vs 18%), dizziness (24% vs 16%), insomnia (24% vs 15%), pruritus
(24% vs 4.8%), peripheral edema (22% vs 18%), dysgeusia (20% vs
11%), alopecia (20% vs 3.2%), upper respiratory tract infection
(20% vs 3.2%), and arthralgia (15% vs 24%). This study was not
designed to demonstrate a statistically significant difference in
adverse reaction rates for KEYTRUDA as compared to carbo/pem alone
for any specified adverse reaction.
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.
KEYTRUDA was discontinued due to adverse reactions in 5% of 210
patients with cHL, and treatment was interrupted due to adverse
reactions in 26% of patients. Fifteen percent (15%) of patients had
an adverse reaction requiring systemic corticosteroid therapy.
Serious adverse reactions occurred in 16% of patients. The most
frequent serious adverse reactions (≥1%) included pneumonia,
pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two
patients died from causes other than disease progression; one from
GVHD after subsequent allogeneic HSCT and one from septic shock.
The most common adverse reactions (occurring in ≥20% of patients)
were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal
pain (21%), diarrhea (20%), and rash (20%).
In KEYNOTE-052, KEYTRUDA was discontinued due to adverse
reactions in 11% of 370 patients with locally advanced or
metastatic urothelial carcinoma. The most common adverse reactions
(in≥20% of patients) were fatigue (38%), musculoskeletal pain
(24%), decreased appetite (22%), constipation (21%), rash (21%),
and diarrhea (20%). Eighteen patients (5%) died from causes other
than disease progression. Five patients (1.4%) who were treated
with KEYTRUDA experienced sepsis which led to death, and 3 patients
(0.8%) experienced pneumonia which led to death. Adverse reactions
leading to interruption of KEYTRUDA (pembrolizumab) occurred in 22%
of patients; the most common (≥1%) were liver enzyme increase,
diarrhea, urinary tract infection, acute kidney injury, fatigue,
joint pain, and pneumonia. Serious adverse reactions occurred in
42% of patients, the most frequent (≥2%) of which were urinary
tract infection, hematuria, acute kidney injury, pneumonia, and
urosepsis.
In KEYNOTE-045, KEYTRUDA was discontinued due to adverse
reactions in 8% of 266 patients with locally advanced or metastatic
urothelial carcinoma. The most common adverse reaction resulting in
permanent discontinuation of KEYTRUDA was pneumonitis (1.9%).
Adverse reactions leading to interruption of KEYTRUDA occurred in
20% of patients; the most common (≥1%) were urinary tract infection
(1.5%), diarrhea (1.5%), and colitis (1.1%). The most common
adverse reactions (20%) in patients who received KEYTRUDA vs those
who received chemotherapy were fatigue (38% vs 56%),
musculoskeletal pain (32% vs 27%), pruritus (23% vs 6%), decreased
appetite (21% vs 21%), nausea (21% vs 29%), and rash (20% vs 13%).
Serious adverse reactions occurred in 39% of KEYTRUDA-treated
patients, the most frequent (≥2%) of which were urinary tract
infection, pneumonia, anemia, and pneumonitis.
There is limited experience in pediatric patients. Efficacy for
pediatric patients was extrapolated from the results in the adult
cHL population. In a study of 40 pediatric patients with advanced
melanoma, PD-L1–positive advanced, relapsed, or refractory solid
tumors or lymphoma, patients were treated with KEYTRUDA for a
median of 43 days (range 1-414 days), with 24 patients (60%)
receiving treatment for 42 days or more. The safety profile in
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%).
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.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based
biopharmaceutical company focused on the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit the Company’s website at
www.incyte.com.
Follow @Incyte on Twitter at https://twitter.com/Incyte.
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, YouTube
and LinkedIn.
Forward-Looking Statement of Incyte Corporation
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding whether the combination of epacadostat plus KEYTRUDA will
offer a safe and effective treatment for patients with advanced
melanoma and the phase 3 trial of epacadostat in combination with
KEYTRUDA for the treatment of melanoma, contain predictions,
estimates and other forward-looking statements. These
forward-looking statements are based on the Company’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, including unanticipated
developments and the risks related to the efficacy or safety of the
Company’s development pipeline, the results of further research and
development, the high degree of risk and uncertainty associated
with drug development, clinical trials and regulatory approval
processes, other market or economic factors and competitive and
technological advances; and other risks detailed from time to time
in the Company’s reports filed with the Securities and Exchange
Commission, including its Form 10-Q for the quarter ended June 30,
2017. Incyte disclaims any intent or obligation to update these
forward-looking statements.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
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 and expectations of the company’s
management and are subject to 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 from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2016
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170909005016/en/
Incyte
ContactsMediaCatalina Loveman, +1
302-498-6171orInvestorsMichael Booth, DPhil, +1
302-498-5914orMerck
ContactsMediaPamela Eisele, +1
267-305-3558Elizabeth Sell, +1 267-305-3877orInvestorsTeri
Loxam, +1 908-740-1986Amy Klug, +1 908-740-1898
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