Only PARP Inhibitor to Improve Overall
Survival vs. Enzalutamide or Abiraterone for Metastatic
Castration-Resistant Prostate Cancer Patients with BRCA or ATM
Mutations, A Key Secondary Endpoint in the Phase 3 PROfound
Trial
Approximately 20-30% of Men with Metastatic
Castration-Resistant Prostate Cancer Have an HRR Gene
Mutation
AstraZeneca and Merck (NYSE:
MRK), known as MSD outside the United States and Canada, today
announced that the U.S. Food and Drug Administration (FDA) has
approved LYNPARZA for the treatment of adult patients with
deleterious or suspected deleterious germline or somatic homologous
recombination repair (HRR) gene-mutated metastatic
castration-resistant prostate cancer (mCRPC) who have progressed
following prior treatment with enzalutamide or abiraterone.
Patients will be selected for therapy based on an FDA-approved
companion diagnostic for LYNPARZA.
The approval was based on
positive results from Phase 3 PROfound trial and published in The
New England Journal of Medicine on April 28, 2020.
Prostate cancer is the
second-most common cancer in men, and despite an increase in the
number of available therapies for men with mCRPC, five-year
survival remains low. HRR gene mutations occur in approximately
20-30% of patients with mCRPC.
Dr. Maha Hussain, one of the
principal investigators of the PROfound trial and deputy director
of the Robert H. Lurie Comprehensive Cancer Center of Northwestern
University, said, “Prostate cancer has lagged behind other solid
tumors in the era of precision medicine. I am thrilled by the
approval of LYNPARZA, which now brings a molecularly targeted
treatment for this patient population in the U.S. The PROfound
trial was an international effort and I want to thank the patients,
their families, the investigators and their teams involved in
making it possible.”
Results from the PROfound
trial showed LYNPARZA reduced the risk of disease progression or
death by 66% (HR 0.34 [95% CI, 0.25-0.47], p<0.0001) and
improved radiographic progression-free survival (rPFS) to a median
of 7.4 months vs. 3.6 months with enzalutamide or abiraterone in
men with mCRPC selected for BRCA1/2 or ATM gene mutations,
the primary endpoint and a
subpopulation of HRR gene mutations. Results also showed LYNPARZA
reduced the risk of radiographic disease progression or death by
51% (HR 0.49 [95% CI, 0.38-0.63], p<0.0001) and improved rPFS to
a median of 5.8 months vs. 3.5 months with enzalutamide or
abiraterone in the overall trial population of men with HRR
gene-mutated mCRPC, a key secondary endpoint.
Additional results announced
in April 2020 showed a statistically significant improvement in the
key secondary endpoint of overall survival (OS) with LYNPARZA vs.
enzalutamide or abiraterone in men with mCRPC and BRCA1/2 or ATM
gene mutations. Results showed LYNPARZA reduced the risk of death
by 31% (HR 0.69 [95% CI, 0.50-0.97], p=0.0175) and improved OS to a
median of 19.1 months vs. 14.7 months for those treated with
enzalutamide or abiraterone.
Venous thromboembolic events,
including pulmonary embolism, occurred in 7% of patients with
metastatic castration-resistant prostate cancer who received
LYNPARZA plus androgen deprivation therapy (ADT) compared to 3.1%
of patients receiving enzalutamide or abiraterone plus ADT in the
PROfound study. Patients receiving LYNPARZA and ADT had a 6%
incidence of pulmonary embolism compared to 0.8% of patients
treated with ADT plus either enzalutamide or
abiraterone.
Dave Fredrickson, executive
vice president, head of the oncology business unit, AstraZeneca,
said, “Today marks the first approval for LYNPARZA in prostate
cancer. In the PROfound trial, LYNPARZA more than doubled the
median radiographic progression-free survival and is the only PARP
inhibitor to improve overall survival versus enzalutamide or
abiraterone for men with BRCA or ATM mutations. These results
further establish that genomic testing for HRR mutations should be
considered a critical step for the diagnosis and determination of
treatment options for men with advanced prostate
cancer.”
Dr. Roy Baynes, senior vice
president and head of global clinical development, chief medical
officer, Merck Research Laboratories, said, “LYNPARZA is the only
PARP inhibitor approved with Phase 3 data for men with HRR
gene-mutated metastatic castration-resistant prostate cancer. This
approval highlights the importance of genomic testing to identify
treatment options for men in this patient population. We are proud
to work in collaboration with AstraZeneca toward our overall goal
of improving outcomes for patients.”
The most common adverse
reactions (ARs) in the PROfound trial ≥10% for LYNPARZA compared to
enzalutamide or abiraterone were anemia (46% vs. 15%), nausea (41%
vs. 19%), fatigue (including asthenia) (41% vs. 32%), decreased
appetite (30% vs. 18%), diarrhea (21% vs. 7%), vomiting (18% vs.
12%), thrombocytopenia (12% vs. 3%), cough (11% vs. 2%), and
dyspnea (10% vs. 3%). Dose interruptions due to an AR occurred in
45% of patients receiving LYNPARZA and dose reductions due to an AR
occurred in 22% of LYNPARZA patients. Discontinuation due to ARs
occurred in 18% of LYNPARZA patients.
Fatal ARs occurred in 4% of
patients treated with LYNPARZA. These included pneumonia (1.2%),
cardiopulmonary failure (0.4%), aspiration pneumonia (0.4%),
intestinal diverticulum (0.4%), septic shock (0.4%), Budd-Chiari
Syndrome (0.4%), sudden death (0.4%), and acute cardiac failure
(0.4%). Serious ARs occurred in 36% of patients receiving LYNPARZA.
The most frequent serious ARs (≥2%) were anemia (9%), pneumonia
(4%), pulmonary embolism (2%), fatigue/asthenia (2%) and urinary
tract infection (2%).
LYNPARZA is currently under
regulatory review in the European Union and other jurisdictions as
a treatment for men with HRR gene-mutated mCRPC.
AstraZeneca and Merck are
exploring additional trials in metastatic prostate cancer,
including the ongoing Phase 3 PROpel trial evaluating LYNPARZA as a
first-line therapy in combination with abiraterone acetate for
patients with mCRPC vs. abiraterone acetate alone.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
There are no contraindications for LYNPARZA.
WARNINGS AND PRECAUTIONS
Myelodysplastic Syndrome/Acute Myeloid Leukemia
(MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA
monotherapy, and the majority of events had a fatal outcome. The
duration of therapy in patients who developed secondary MDS/AML
varied from <6 months to >2 years. All of these patients had
previous chemotherapy with platinum agents and/or other
DNA-damaging agents, including radiotherapy, and some also had a
history of more than one primary malignancy or of bone marrow
dysplasia.
Do not start LYNPARZA until patients have recovered from
hematological toxicity caused by previous chemotherapy (≤Grade 1).
Monitor complete blood count for cytopenia at baseline and monthly
thereafter for clinically significant changes during treatment. For
prolonged hematological toxicities, interrupt LYNPARZA and monitor
blood count weekly until recovery.
If the levels have not recovered to Grade 1 or less after 4
weeks, refer the patient to a hematologist for further
investigations, including bone marrow analysis and blood sample for
cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.
Pneumonitis: Occurred in <1% of patients exposed to
LYNPARZA, and some cases were fatal. If patients present with new
or worsening respiratory symptoms such as dyspnea, cough, and
fever, or a radiological abnormality occurs, interrupt LYNPARZA
treatment and initiate prompt investigation. Discontinue LYNPARZA
if pneumonitis is confirmed and treat patient appropriately.
Embryo-Fetal Toxicity: Based on its mechanism of action
and findings in animals, LYNPARZA can cause fetal harm. A pregnancy
test is recommended for females of reproductive potential prior to
initiating treatment.
Females
Advise females of reproductive potential of the potential risk
to a fetus and to use effective contraception during treatment and
for 6 months following the last dose.
Males
Advise male patients with female partners of reproductive
potential or who are pregnant to use effective contraception during
treatment and for 3 months following the last dose of LYNPARZA and
to not donate sperm during this time.
Venous Thromboembolic Events: Including pulmonary
embolism, occurred in 7% of patients with metastatic
castration-resistant prostate cancer who received LYNPARZA plus
androgen deprivation therapy (ADT) compared to 3.1% of patients
receiving enzalutamide or abiraterone plus ADT in the PROfound
study. Patients receiving LYNPARZA and ADT had a 6% incidence of
pulmonary embolism compared to 0.8% of patients treated with ADT
plus either enzalutamide or abiraterone. Monitor patients for signs
and symptoms of venous thrombosis and pulmonary embolism, and treat
as medically appropriate, which may include long-term
anticoagulation as clinically indicated.
ADVERSE REACTIONS—First-Line Maintenance BRCAm Advanced
Ovarian Cancer
Most common adverse reactions (Grades 1-4) in ≥10% of patients
in clinical trials of LYNPARZA in the first-line maintenance
setting for SOLO-1 were: nausea (77%), fatigue (67%),
abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%),
constipation (28%), upper respiratory tract infection/influenza/
nasopharyngitis/bronchitis (28%), dysgeusia (26%), decreased
appetite (20%), dizziness (20%), neutropenia (17%), dyspepsia
(17%), dyspnea (15%), leukopenia (13%), UTI (13%), thrombocytopenia
(11%), and stomatitis (11%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients in clinical trials of LYNPARZA in the first-line
maintenance setting for SOLO-1 were: decrease in hemoglobin
(87%), increase in mean corpuscular volume (87%), decrease in
leukocytes (70%), decrease in lymphocytes (67%), decrease in
absolute neutrophil count (51%), decrease in platelets (35%), and
increase in serum creatinine (34%).
ADVERSE REACTIONS—First-Line Maintenance Advanced Ovarian
Cancer in Combination with Bevacizumab
Most common adverse reactions (Grades 1-4) in ≥10% of patients
treated with LYNPARZA/bevacizumab compared to a ≥5% frequency for
placebo/bevacizumab in the first-line maintenance setting
for PAOLA-1 were: nausea (53%), fatigue (including asthenia)
(53%), anemia (41%), lymphopenia (24%), vomiting (22%) and
leukopenia (18%). In addition, the most common adverse reactions
(≥10%) for patients receiving LYNPARZA/bevacizumab irrespective of
the frequency compared with the placebo/bevacizumab arm were:
diarrhea (18%), neutropenia (18%), urinary tract infection (15%),
and headache (14%).
In addition, venous thromboembolic events occurred more commonly
in patients receiving LYNPARZA/bevacizumab (5%) than in those
receiving placebo/bevacizumab (1.9%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients for LYNPARZA in combination with bevacizumab in the
first-line maintenance setting for PAOLA-1 were:
decrease in hemoglobin (79%), decrease in lymphocytes (63%),
increase in serum creatinine (61%), decrease in leukocytes (59%),
decrease in absolute neutrophil count (35%), and decrease in
platelets (35%).
ADVERSE REACTIONS—Maintenance Recurrent Ovarian
Cancer
Most common adverse reactions (Grades 1-4) in ≥20% of patients
in clinical trials of LYNPARZA in the maintenance setting
for SOLO-2 were: nausea (76%), fatigue (including asthenia)
(66%), anemia (44%), vomiting (37%), nasopharyngitis/upper
respiratory tract infection (URI)/influenza (36%), diarrhea (33%),
arthralgia/myalgia (30%), dysgeusia (27%), headache (26%),
decreased appetite (22%), and stomatitis (20%).
Study 19: nausea (71%), fatigue (including asthenia)
(63%), vomiting (35%), diarrhea (28%), anemia (23%), respiratory
tract infection (22%), constipation (22%), headache (21%),
decreased appetite (21%), and dyspepsia (20%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients in clinical trials of LYNPARZA in the maintenance
setting (SOLO-2/Study 19) were: increase in mean corpuscular
volume (89%/82%), decrease in hemoglobin (83%/82%), decrease in
leukocytes (69%/58%), decrease in lymphocytes (67%/52%), decrease
in absolute neutrophil count (51%/47%), increase in serum
creatinine (44%/45%), and decrease in platelets (42%/36%).
ADVERSE REACTIONS—Advanced gBRCAm Ovarian Cancer
Most common adverse reactions (Grades 1-4) in ≥20% of patients
in clinical trials of LYNPARZA for advanced gBRCAm ovarian
cancer after 3 or more lines of chemotherapy (pooled from 6
studies) were: fatigue/asthenia (66%), nausea (64%), vomiting
(43%), anemia (34%), diarrhea (31%), nasopharyngitis/upper
respiratory tract infection (URI) (26%), dyspepsia (25%), myalgia
(22%), decreased appetite (22%), and arthralgia/musculoskeletal
pain (21%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients in clinical trials of LYNPARZA for advanced gBRCAm
ovarian cancer (pooled from 6 studies) were: decrease in
hemoglobin (90%), mean corpuscular volume elevation (57%), decrease
in lymphocytes (56%), increase in serum creatinine (30%), decrease
in platelets (30%), and decrease in absolute neutrophil count
(25%).
ADVERSE REACTIONS—gBRCAm, HER2-negative Metastatic Breast
Cancer
Most common adverse reactions (Grades 1-4) in ≥20% of patients
in OlympiAD were: nausea (58%), anemia (40%), fatigue
(including asthenia) (37%), vomiting (30%), neutropenia (27%),
respiratory tract infection (27%), leukopenia (25%), diarrhea
(21%), and headache (20%).
Most common laboratory abnormalities (Grades 1-4) in
>25% of patients in OlympiAD
were: decrease in hemoglobin (82%), decrease in lymphocytes (73%),
decrease in leukocytes (71%), increase in mean corpuscular volume
(71%), decrease in absolute neutrophil count (46%), and decrease in
platelets (33%).
ADVERSE REACTIONS—First-Line Maintenance gBRCAm Metastatic
Pancreatic Adenocarcinoma
Most common adverse reactions (Grades 1-4) in ≥10% of patients
in clinical trials of LYNPARZA in the first-line maintenance
setting for POLO were: fatigue (60%), nausea (45%),
abdominal pain (34%), diarrhea (29%), anemia (27%), decreased
appetite (25%), constipation (23%), vomiting (20%), back pain
(19%), arthralgia (15%), rash (15%), thrombocytopenia (14%),
dyspnea (13%), neutropenia (12%), nasopharyngitis (12%), dysgeusia
(11%), and stomatitis (10%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients in clinical trials of LYNPARZA in the first-line
maintenance setting for POLO were: increase in serum creatinine
(99%), decrease in hemoglobin (86%), increase in mean corpuscular
volume (71%), decrease in lymphocytes (61%), decrease in platelets
(56%), decrease in leukocytes (50%), and decrease in absolute
neutrophil count (25%).
ADVERSE REACTIONS—HRR Gene-mutated Metastatic Castration
Resistant Prostate Cancer
Most common adverse reactions (Grades 1-4) in ≥10% of patients
in clinical trials of LYNPARZA for PROfound were: anemia
(46%), fatigue (including asthenia) (41%), nausea (41%), decreased
appetite (30%), diarrhea (21%), vomiting (18%), thrombocytopenia
(12%), cough (11%), and dyspnea (10%).
Most common laboratory abnormalities (Grades 1-4) in ≥25% of
patients in clinical trials of LYNPARZA for PROfound were:
decrease in hemoglobin (98%), decrease in lymphocytes (62%),
decrease in leukocytes (53%), and decrease in absolute neutrophil
count (34%).
DRUG INTERACTIONS
Anticancer Agents: Clinical studies of LYNPARZA with
other myelosuppressive anticancer agents, including DNA-damaging
agents, indicate a potentiation and prolongation of
myelosuppressive toxicity.
CYP3A Inhibitors: Avoid coadministration of strong or
moderate CYP3A inhibitors when using LYNPARZA. If a strong or
moderate CYP3A inhibitor must be coadministered, reduce the dose of
LYNPARZA. Advise patients to avoid grapefruit, grapefruit juice,
Seville oranges, and Seville orange juice during LYNPARZA
treatment.
CYP3A Inducers: Avoid coadministration of strong or
moderate CYP3A inducers when using LYNPARZA.
USE IN SPECIFIC POPULATIONS
Lactation: No data are available regarding the presence
of olaparib in human milk, its effects on the breastfed infant or
on milk production. Because of the potential for serious adverse
reactions in the breastfed infant, advise a lactating woman not to
breastfeed during treatment with LYNPARZA and for 1 month after
receiving the final dose.
Pediatric Use: The safety and efficacy of LYNPARZA have
not been established in pediatric patients.
Hepatic Impairment: No adjustment to the starting dose is
required in patients with mild or moderate hepatic impairment
(Child-Pugh classification A and B). There are no data in patients
with severe hepatic impairment (Child-Pugh classification C).
Renal Impairment: No dosage modification is recommended
in patients with mild renal impairment (CLcr 51-80 mL/min estimated
by Cockcroft-Gault). In patients with moderate renal impairment
(CLcr 31-50 mL/min), reduce the dose of LYNPARZA to 200 mg twice
daily. There are no data in patients with severe renal impairment
or end-stage renal disease (CLcr ≤30 mL/min).
INDICATIONS
LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor
indicated:
First-Line Maintenance BRCAm Advanced Ovarian Cancer
For the maintenance treatment of adult patients with deleterious
or suspected deleterious germline or somatic BRCA-mutated (gBRCAm
or sBRCAm) advanced epithelial ovarian, fallopian tube or primary
peritoneal cancer who are in complete or partial response to
first-line platinum-based chemotherapy. Select patients for therapy
based on an FDA-approved companion diagnostic for LYNPARZA.
First-Line Maintenance HRD Positive Advanced Ovarian Cancer
in Combination with Bevacizumab
In combination with bevacizumab for the maintenance treatment of
adult patients with advanced epithelial ovarian, fallopian tube or
primary peritoneal cancer who are in complete or partial response
to first-line platinum-based chemotherapy and whose cancer is
associated with homologous recombination deficiency (HRD) positive
status defined by either:
- a deleterious or suspected deleterious BRCA mutation
and/or
- genomic instability
Select patients for therapy based on an FDA-approved companion
diagnostic for LYNPARZA.
Maintenance Recurrent Ovarian Cancer
For the maintenance treatment of adult patients with recurrent
epithelial ovarian, fallopian tube or primary peritoneal cancer,
who are in complete or partial response to platinum-based
chemotherapy.
Advanced gBRCAm Ovarian Cancer
For the treatment of adult patients with deleterious or
suspected deleterious germline BRCA-mutated (gBRCAm) advanced
ovarian cancer who have been treated with 3 or more prior lines of
chemotherapy. Select patients for therapy based on an FDA-approved
companion diagnostic for LYNPARZA.
gBRCAm HER2-negative Metastatic Breast Cancer
For the treatment of adult patients with deleterious or
suspected deleterious gBRCAm, human epidermal growth factor
receptor 2 (HER2)-negative metastatic breast cancer, who have been
treated with chemotherapy in the neoadjuvant, adjuvant or
metastatic setting. Patients with hormone receptor (HR)-positive
breast cancer should have been treated with a prior endocrine
therapy or be considered inappropriate for endocrine therapy.
Select patients for therapy based on an FDA-approved companion
diagnostic for LYNPARZA.
First-Line Maintenance gBRCAm Metastatic Pancreatic
Cancer
For the maintenance treatment of adult patients with deleterious
or suspected deleterious gBRCAm metastatic pancreatic
adenocarcinoma whose disease has not progressed on at least 16
weeks of a first-line platinum-based chemotherapy regimen. Select
patients for therapy based on an FDA-approved companion diagnostic
for LYNPARZA.
HRR Gene-mutated Metastatic Castration Resistant Prostate
Cancer
For the treatment of adult patients with deleterious or
suspected deleterious germline or somatic homologous recombination
repair (HRR) gene-mutated metastatic castration-resistant prostate
cancer (mCRPC) who have progressed following prior treatment with
enzalutamide or abiraterone. Select patients for therapy based on
an FDA-approved companion diagnostic for LYNPARZA.
Please click here for complete Prescribing Information,
including Patient Information (Medication Guide).
Financial Considerations
Under the oncology collaboration with AstraZeneca and following
this new approval for LYNPARZA, AstraZeneca will receive a $35
million payment from Merck.
About PROfound
PROfound is a prospective, multi-center, randomized, open-label,
Phase 3 trial evaluating the efficacy and safety of LYNPARZA vs.
enzalutamide or abiraterone in patients with mCRPC who have
progressed on prior treatment with a new hormonal anticancer
treatment and have a qualifying tumor mutation in one of 15 genes
involved in the homologous recombination repair (HRR) pathway,
among them BRCA1/2, ATM and CDK12.
The trial was designed to analyze patients with HRR mutated
genes in two cohorts: the primary endpoint was in those with
mutations in BRCA1/2 or ATM genes and then, if LYNPARZA showed
clinical benefit, a formal analysis was performed of the overall
trial population of patients with HRR mutated genes (BRCA1/2, ATM,
CDK12 and 11 other HRR mutated genes; key secondary endpoint).
In the U.S., patients are
selected for treatment with LYNPARZA based on the following
FDA-approved companion diagnostics:
- FoundationOne CDX: to identify patients with HRR gene
alterations in prostate tumor tissue. FoundationOne is a registered
trademark of Foundation Medicine, Inc.
- BRACAnalysis CDX: a germline test to identify patients with
BRCA1 and BRCA2 gene mutations. Myriad Genetics, Inc. owns and
commercializes BRACAnalysis CDX.
About LYNPARZA® (olaparib)
LYNPARZA is a first-in-class PARP inhibitor and the first
targeted treatment to potentially exploit DNA damage response (DDR)
pathway deficiencies, such as BRCA mutations, to preferentially
kill cancer cells. Inhibition of PARP with LYNPARZA leads to the
trapping of PARP bound to DNA single-strand breaks, stalling of
replication forks, their collapse and the generation of DNA
double-strand breaks and cancer cell death. LYNPARZA is being
tested in a range of tumor types with defects and dependencies in
the DDR.
LYNPARZA, which is being jointly developed and commercialized by
AstraZeneca and Merck, has a broad and advanced clinical trial
development program, and AstraZeneca and Merck are working together
to understand how it may affect multiple PARP-dependent tumors as a
monotherapy and in combination across multiple cancer types.
About Metastatic Castration-Resistant Prostate Cancer
(mCRPC)
Prostate cancer is the second most common cancer in men and is
associated with a significant mortality rate. In the U.S. this
year, it is estimated that more than 191,900 people will be
diagnosed with prostate cancer and more than 33,300 people will die
of this disease. HRR gene mutations occur in approximately 20-30%
of patients with mCRPC.
Development of prostate cancer is often driven by male sex
hormones called androgens, including testosterone. mCRPC occurs
when prostate cancer grows and spreads to other parts of the body
despite the use of androgen-deprivation therapy to block the action
of male sex hormones. Approximately 10-20% of men with advanced
prostate cancer will develop CRPC within five years, and at least
84% of these will have metastases at the time of CRPC diagnosis. Of
men with no metastases at CRPC diagnosis, 33% are likely to develop
metastases within two years. Despite an increase in the number of
available therapies, five-year survival for men with mCRPC remains
low.
About Homologous Recombination Repair (HRR) Mutations
Homologous recombination repair (HRR) plays a significant role
in maintaining the genetic stability of cells and suppressing tumor
growth by repairing damaged DNA. Mutations, or defects, in
homologous recombination (HR) pathway genes – which include ataxia
telangiectasia mutated (ATM) and BRCA1/2 genes – increase the risk
for breast, ovarian, pancreatic, prostate and other cancers.
About the AstraZeneca and Merck Strategic Oncology
Collaboration
In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth,
NJ, US, known as MSD outside the United States and Canada,
announced a global strategic oncology collaboration to co-develop
and co-commercialize certain oncology products including LYNPARZA,
the world’s first PARP inhibitor. Working together, the companies
will develop these products in combination with other potential new
medicines and as monotherapies. Independently, the companies will
develop these oncology products in combination with their
respective PD-L1 and PD-1 medicines.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck,
the potential to bring new hope to people with cancer drives our
purpose and supporting accessibility to our cancer medicines is our
commitment. As part of our focus on cancer, Merck is committed to
exploring the potential of immuno-oncology with one of the largest
development programs in the industry across more than 30 tumor
types. We also continue to strengthen our portfolio through
strategic acquisitions and are prioritizing the development of
several promising oncology 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 125 years, Merck, 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 in pursuit of our mission to save and improve
lives. We demonstrate our commitment to patients and population
health by increasing access to health care through far-reaching
policies, programs and partnerships. Today, Merck continues to be
at the forefront of research to prevent and treat diseases that
threaten people and animals – including cancer, infectious diseases
such as HIV and Ebola, and emerging animal diseases – as we aspire
to be the premier research-intensive biopharmaceutical company in
the world. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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 the recent global outbreak of novel coronavirus
disease (COVID-19); 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 2019
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).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200520005216/en/
Media Contacts: Pamela Eisele (267) 305-3558
Steve Wanczyk (267) 305-5563
Investor Contacts: Peter Dannenbaum (908) 740-1037
Courtney Ronaldo (908) 740-6132
Merck (NYSE:MRK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2023 to Apr 2024