Agreement to Combine Merck’s Investigational
Anti-PD-1 Antibody Pembrolizumab and Pfizer’s Crizotinib
(XALKORI®) in Clinical Trial
Pfizer Inc. (NYSE:PFE) and Merck & Co. Inc. (NYSE:MRK),
known as MSD outside the United States and Canada, through a
subsidiary, announced today that they have entered into an
agreement to explore the therapeutic potential of the combination
of Pfizer’s crizotinib (XALKORI®) with Merck’s investigational
anti-PD-1 antibody pembrolizumab, in a Phase 1b clinical study
evaluating the safety and tolerability of the combination in
patients with ALK-positive advanced or metastatic non-small cell
lung cancer (NSCLC). The financial terms of the agreement were not
disclosed.
“This collaboration between Pfizer and Merck is just one example
of the willingness of sponsors to work together in an effort to
accelerate progress against some of the most difficult-to-treat
cancers,” said Dr. Mace Rothenberg, senior vice president of
Clinical Development and Medical Affairs and chief medical officer
for Pfizer Oncology. “Understanding the effects of combining one
drug, XALKORI, which inhibits an abnormally activated enzyme in
patients with ALK-positive metastatic lung cancer, with the
investigational drug, pembrolizumab, which harnesses the body’s
immune system to fight cancer, is vital if we are to continue to
advance the care of lung cancer patients.”
This multi-center, open-label clinical study is expected to
begin in 2015. Pfizer will conduct the study.
“We are pleased to build upon our ongoing collaboration with
Pfizer to evaluate potential combination regimens incorporating
Merck’s investigational immunotherapy pembrolizumab,” said Dr. Eric
Rubin, vice president, Oncology, Merck Research Laboratories.
“Evidence from early studies of pembrolizumab monotherapy together
with XALKORI’s proven targeted therapeutic approach provides the
scientific rationale for evaluating this combination for the
treatment of lung cancer.”
Both companies previously announced plans to evaluate the safety
and efficacy of pembrolizumab in combination with Pfizer’s small
molecule kinase inhibitor axitinib (INLYTA®) in patients with renal
cell carcinoma. Separately, pembrolizumab plus Pfizer’s PF-05082566
(PF-2566), an investigational immuno-oncology agent that targets
the human 4-1BB receptor, will be evaluated in multiple cancer
types. These studies are expected to begin enrollment later this
year.
About Pembrolizumab
Pembrolizumab (MK-3475) is an investigational, humanized,
monoclonal antibody against PD-1 designed to reactivate anti-tumor
immunity. Pembrolizumab exerts dual ligand blockade of the PD-1
pathway by inhibiting the interaction of PD-1 on T cells with its
ligands PD-L1 and PD-L2.
Pembrolizumab is currently being evaluated across more than 30
types of cancers, as monotherapy and in combination. It is
anticipated that by the end of 2014, the pembrolizumab development
program will grow to more than 24 clinical trials, enrolling an
estimated 6,000 patients at nearly 300 clinical trial sites
worldwide. For information about Merck’s oncology clinical studies,
please
visit http://www.merck.com/clinical-trials/index.html.
XALKORI® (crizotinib) Indication and Important
Safety Information
XALKORI is a kinase inhibitor indicated for the treatment of
patients with metastatic non-small cell lung cancer (NSCLC) whose
tumors are anaplastic lymphoma kinase (ALK)-positive as detected by
an FDA-approved test.
Hepatotoxicity: Across three main clinical trials fatal
hepatotoxicity occurred in 0.2% of patients. Monitor with periodic
liver testing. Temporarily suspend, dose reduce, or permanently
discontinue XALKORI.
Pneumonitis: Across three main clinical trials interstitial lung
disease (ILD)/pneumonitis occurred in 2% of patients. Permanently
discontinue in patients with ILD/pneumonitis.
QT Interval Prolongation: Across three main clinical trials QT
interval prolongation occurred in 2.7% of patients. Monitor with
electrocardiograms and electrolytes in patients who have a history
of or predisposition for QTc prolongation, or who are taking
medications that prolong QT. Temporarily suspend, dose reduce, or
permanently discontinue XALKORI.
Bradycardia: Xalkori can cause bradycardia. Across three main
clinical trials 11% of patients experienced a heart rate of less
than 50 beats per minute. Monitor heart rate and blood pressure
regularly. Temporarily suspend, dose reduce, or permanently
discontinue XALKORI.
Embryofetal Toxicity: XALKORI can cause fetal harm when
administered to a pregnant woman. Women of childbearing potential
should be advised to avoid becoming pregnant while receiving
XALKORI.
Adverse Reactions: Across three main clinical trials the most
common adverse reactions (≥25%) were vision disorders, nausea,
diarrhea, vomiting, constipation, edema, elevated transaminases,
and fatigue.
In a phase 3 study in patients with ALK-positive metastatic
NSCLC randomized to XALKORI (n=172) or chemotherapy (n=171),
serious adverse reactions were reported in 37.2% of patients
treated with XALKORI. The most frequent serious adverse reactions
reported in patients treated with XALKORI were pneumonia (4.1%),
pulmonary embolism (3.5%), dyspnea (2.3%), and ILD (2.9%). Fatal
adverse reactions in XALKORI-treated patients occurred in 9 (5%)
patients, consisting of: acute respiratory distress syndrome,
arrhythmia, dyspnea, ILD, pneumonia, pneumonitis, pulmonary
embolism, respiratory failure, and sepsis. Grade 3 or 4 events
occurring at a higher incidence with XALKORI than with chemotherapy
and at greater than 2%, were syncope (3%), QT prolongation (3%),
and pulmonary embolism (5%). Elevation of ALT of any grade occurred
in 76% of patients and grade 3 or 4 in 17% of patients. Neutropenia
of any grade occurred in 49% of patients and grade 3 or 4 in 12% of
patients. Lymphopenia of any grade occurred in 51% of patients and
grade 3 or 4 in 9% of patients. Renal cysts occurred in 4% and
neuropathy occurred in 19% of patients treated with XALKORI.
Drug Interactions: Exercise caution with concomitant use of
moderate CYP3A inhibitors. Avoid grapefruit or grapefruit juice
which may increase plasma concentrations of crizotinib. Avoid
concomitant use of strong CYP3A inducers and inhibitors. Dose
reduction may be needed for co-administered drugs that are
predominantly metabolized by CYP3A.
Nursing Mothers: Given the potential for serious adverse
reactions in nursing infants, consider whether to discontinue
nursing or discontinue XALKORI.
Hepatic Impairment: XALKORI has not been studied in patients
with hepatic impairment. As crizotinib is extensively metabolized
in the liver, hepatic impairment is likely to increase plasma
crizotinib concentrations. Use caution in patients with hepatic
impairment.
Renal Impairment: Administer XALKORI at a starting dose of 250
mg taken orally once daily in patients with severe renal impairment
(CLcr<30 mL/min) not requiring dialysis. No starting dose
adjustment is needed for patients with mild and moderate renal
impairment.
For more information and full prescribing information, please
visit www.XALKORI.com.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and
development of innovative treatment options to improve the outlook
for cancer patients worldwide. Our strong pipeline of biologics and
small molecules, one of the most robust in the industry, is studied
with precise focus on identifying and translating the best
scientific breakthroughs into clinical application for patients
across a wide range of cancers. By working collaboratively with
academic institutions, individual researchers, cooperative research
groups, governments, and licensing partners, Pfizer Oncology
strives to cure or control cancer with breakthrough medicines, to
deliver the right drug for each patient at the right time. For more
information, please visit www.Pfizer.com.
About Merck Oncology
At Merck Oncology, our goal is to translate breakthrough science
into biomedical innovations to help people with cancer worldwide.
Harnessing immune mechanisms to fight cancer is the priority focus
of our oncology research and development program. The Company is
advancing a pipeline of immunotherapy candidates and combination
regimens. Cancer is one of the world's most urgent unmet medical
needs. Helping to empower people to fight cancer is our passion.
For information about Merck’s commitment to Oncology visit the
Oncology Information Center at
http://www.mercknewsroom.com/oncology-infocenter.
About Merck
Today's Merck is a global healthcare 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 consumer care 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 healthcare through far-reaching policies,
programs and partnerships. For more information,
visit www.merck.com and connect with us
on Twitter, Facebook and YouTube.
PFIZER DISCLOSURE NOTICE
The information contained in this release is as of August 26,
2014. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new
information or future events or developments.
This release contains forward-looking information about an
agreement between Pfizer and Merck to study the anti-cancer
therapeutic potential of Pfizer’s XALKORI in combination with
Merck’s investigational anti-PD-1 antibody pembrolizumab (MK-3475),
as well as agreements entered into earlier this year between Pfizer
and Merck to study the anti-cancer therapeutic potential of
Pfizer’s INLYTA (axitinib) and PF-2566 in combination with Merck’s
pembrolizumab, that involves substantial risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied by such statements. Risks and uncertainties
include, among other things, the uncertainties inherent in research
and development, including the ability to meet anticipated clinical
study commencement and completion dates as well as the possibility
of unfavorable study results; whether and when drug applications
may be filed in any jurisdictions for any of the combination
therapies; whether and when any such applications may be approved
by regulatory authorities, as well as their decisions regarding
labeling and other matters that could affect the availability or
commercial potential of any of the combination therapies; and
competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2013 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information That May Affect Future Results”, as
well as in its subsequent reports on Form 8-K, all of which are
filed with the SEC and available at www.sec.gov and
www.pfizer.com.
Merck Forward-Looking Statement
This news release includes “forward-looking statements” within
the meaning of the safe harbor provisions of the United States
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of Merck’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 healthcare
legislation in the United States and internationally; global trends
toward healthcare cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; Merck’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 Merck’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
Merck 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 Merck’s 2013 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).
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