INDIANAPOLIS and KENILWORTH, N.J., Nov.
19, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE:
LLY) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the extension of an
existing collaboration to evaluate the safety and efficacy of the
combination of Lilly's ALIMTA® (pemetrexed for injection) and
Merck's KEYTRUDA® (pembrolizumab) in a pivotal Phase III study in
first-line nonsquamous non-small cell lung cancer (NSCLC). The
study will be sponsored by Merck and will be open to patients with
NSCLC in the first-line setting, regardless of PD-L1 status.
Financial details of the collaboration were not disclosed.
The expansion of this oncology clinical trial collaboration
comes following the release of encouraging data from a Phase I
study, presented earlier this year at the 16th World
Congress on Lung Cancer, which evaluated pemetrexed, carboplatin
and pembrolizumab in first-line nonsquamous NSCLC.
Pemetrexed is a leading therapeutic option used in combination
with platinum-based therapies in this setting, making it an ideal
candidate for combination studies with immunotherapy treatments.
Pembrolizumab is a humanized monoclonal antibody that works
by increasing the ability of the body's immune system to help
detect and fight tumor cells. Pembrolizumab 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 –
and is currently approved as a single-agent therapy for certain
types of NSCLC.
"The extension of our immuno-oncology collaboration with Merck
reinforces our combination-focused strategy, which we believe has
the potential to help this patient population where there is a
significant unmet need," said Richard
Gaynor, M.D., senior vice president, product development and
medical affairs for Lilly Oncology. "Building upon this scientific
partnership represents our shared, strong commitment to improve the
lives of those living with cancer."
"Based on the data for ALIMTA, we believe this collaboration
with Lilly has great potential to help even more patients," said
Roger Dansey, M.D.,
therapeutic area head and senior vice president, oncology late
stage development, Merck Research Laboratories. "We look forward to
continuing our collaboration with Lilly across all of these trials
– including the registrational Phase III all-comers trial for
NSCLC."
In addition to the studies of pemetrexed and pembrolizumab in
first-line nonsquamous NSCLC, other ongoing trials from the
original agreement between Lilly and Merck, through a subsidiary,
include:
- A Phase I/II study examining the combination of ramucirumab
with pembrolizumab in multiple tumors.
- A Phase I/II study examining the combination of necitumumab
with pembrolizumab in NSCLC.
NOTES TO EDITORS
About KEYTRUDA® (pembrolizumab) Injection 100
mg
KEYTRUDA is indicated in the United States at a dose of 2 mg/kg
administered as an intravenous infusion over 30 minutes every three
weeks for the treatment of patients with metastatic non-small cell
lung cancer (NSCLC) whose tumors express PD-L1 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
is also indicated at the same dosing for the treatment of patients
with unresectable or metastatic melanoma and disease progression
following ipilimumab and, if BRAF V600 mutation positive, a BRAF
inhibitor. These indications are approved under accelerated
approval based on tumor response rate and durability of response.
An improvement in survival or disease-related symptoms has not yet
been established. Continued approval for these indications may be
contingent upon verification and description of clinical benefit in
the confirmatory trials.
Selected Important Safety Information for
KEYTRUDA® (pembrolizumab)
Pneumonitis, including fatal cases, occurred in patients receiving
KEYTRUDA. Pneumonitis occurred in 12 (2.9%) of 411 melanoma
patients, including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%)
patients, respectively, receiving KEYTRUDA. Pneumonitis occurred in
19 (3.5%) of 550 patients with NSCLC, including Grade 2 (1.1%), 3
(1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis in patients, receiving
KEYTRUDA. 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.
Colitis (including microscopic colitis) occurred in 4 (1%) of
411 patients with melanoma, including Grade 2 or 3 cases in 1
(0.2%) and 2 (0.5%) patients, respectively, receiving KEYTRUDA.
Colitis occurred in 4 (0.7 %) of 550 patients with NSCLC,
including Grade 2 (0.2%) or 3 (0.4%) colitis in patients receiving
KEYTRUDA. 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.
Hepatitis occurred in patients receiving KEYTRUDA. Hepatitis
(including autoimmune hepatitis) occurred in 2 (0.5%) of 411
patients with melanoma, including a Grade 4 case in 1 (0.2%)
patient, receiving KEYTRUDA. 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.
Hypophysitis occurred in 2 (0.5%) of 411 patients with melanoma,
including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each)
patient, receiving KEYTRUDA. Hypophysitis occurred in 1 (0.2 %) of
550 patients with NSCLC, which was Grade 3 in severity. Monitor
patients for signs and symptoms of hypophysitis (including
hypopituitarism and adrenal insufficiency). Administer
corticosteroids and hormone replacement as indicated. Withhold
KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or
Grade 4 hypophysitis.
Hyperthyroidism occurred in 5 (1.2%) of 411 patients with
melanoma, including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%)
patients, respectively, receiving KEYTRUDA. Hypothyroidism occurred
in 34 (8.3%) of 411 patients with melanoma, including a Grade 3
case in 1 (0.2%) patient, receiving KEYTRUDA. Hyperthyroidism
occurred in 10 (1.8%) of 550 patients with NSCLC, including Grade 2
(0.7%) or 3 (0.3%). Hypothyroidism occurred in 38 (6.9%) of 550
patients with NSCLC, including Grade 2 (5.5%) or 3 (0.2%). Thyroid
disorders can occur at any time during treatment. 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 Grade
4 hyperthyroidism.
Type 1 diabetes mellitus, including diabetic ketoacidosis, has
occurred in patients receiving KEYTRUDA. Monitor patients for
hyperglycemia or other signs and symptoms of diabetes. Administer
insulin for type 1 diabetes, and withhold KEYTRUDA and administer
anti-hyperglycemics in patients with severe hyperglycemia.
Nephritis occurred in patients receiving KEYTRUDA. Nephritis
occurred in 3 (0.7%) patients with melanoma, consisting of one case
of Grade 2 autoimmune nephritis (0.2%) and two cases of
interstitial nephritis with renal failure (0.5%), one Grade 3 and
one Grade 4. 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.
Other clinically important immune-mediated adverse reactions can
occur. 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 of the adverse
reaction to Grade 1 or less, initiate corticosteroid taper and
continue to taper over at least 1 month. Resume KEYTRUDA when the
adverse reaction remains at Grade 1 or less following steroid
taper. Permanently discontinue KEYTRUDA for any severe or Grade 3
immune-mediated adverse reaction that recurs and for any
life-threatening immune-mediated adverse reaction.
Across clinical studies with KEYTRUDA, the following clinically
significant, immune-mediated adverse reactions have occurred:
bullous pemphigoid and Guillain-Barré syndrome. The following
clinically significant, immune-mediated adverse reactions occurred
in less than 1% of patients with melanoma treated with KEYTRUDA:
exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis,
hemolytic anemia, and partial seizures arising in a patient with
inflammatory foci in brain parenchyma. The following clinically
significant, immune-mediated adverse reactions occurred in less
than 1% of 550 patients with NSCLC treated with KEYTRUDA: rash,
vasculitis, hemolytic anemia, serum sickness, and myasthenia
gravis.
Infusion-related reactions, including severe and
life-threatening reactions, have occurred in patients receiving
KEYTRUDA. Monitor patients for signs and symptoms of infusion
related reactions including rigors, chills, wheezing, pruritus,
flushing, rash, hypotension, hypoxemia, and fever. For severe or
life-threatening 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.
Among the 411 patients with metastatic melanoma, KEYTRUDA was
discontinued for adverse reactions in 9% of 411 patients. Adverse
reactions, reported in at least two patients, that led to
discontinuation of KEYTRUDA were: pneumonitis, renal failure, and
pain. Serious adverse reactions occurred in 36% of patients. The
most frequent serious adverse reactions, reported in 2% or more of
patients, were renal failure, dyspnea, pneumonia, and cellulitis.
The most common adverse reactions (reported in at least 20% of
patients) were fatigue (47%), cough (30%), nausea (30%), pruritus
(30%), rash (29%), decreased appetite (26%), constipation (21%),
arthralgia (20%), and diarrhea (20%).
Among the 550 patients with metastatic NSCLC, KEYTRUDA was
discontinued due to adverse reactions in 14% of patients. Serious
adverse reactions occurred in 38% of patients. The most frequent
serious adverse reactions reported in 2% or more of patients were
pleural effusion, pneumonia, dyspnea, pulmonary embolism, and
pneumonitis. The most common adverse reactions (reported in at
least 20% of patients) were fatigue (44%), decreased appetite
(25%), dyspnea (23%), and cough (29%).
No formal pharmacokinetic drug interaction studies have been
conducted with KEYTRUDA.
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.
About ALIMTA® (pemetrexed)
In 2004, ALIMTA
received consecutive approvals: it was the first agent to be
approved in combination with cisplatin as a treatment for patients
with malignant pleural mesothelioma, whose disease is unresectable
or who are otherwise not candidates for curative surgery, and then
as a single agent for the second-line treatment of patients with
locally advanced or metastatic NSCLC after prior chemotherapy
treatment.
In 2008, ALIMTA, in combination with cisplatin, was approved as
a first-line treatment for locally advanced or metastatic NSCLC for
patients with nonsquamous histology. At the time of the first-line
approval, the FDA also approved a change to the
second-line indication. ALIMTA is now indicated as a single agent
for the treatment of patients with locally advanced or metastatic,
nonsquamous NSCLC after prior chemotherapy.
In 2009, ALIMTA was approved as a maintenance therapy for
locally advanced or metastatic NSCLC, specifically for patients
with a nonsquamous histology whose disease has not progressed after
four cycles of platinum-based first-line chemotherapy.
In 2012, ALIMTA was approved by the FDA as a
continuation maintenance therapy for locally-advanced or metastatic
NSCLC, following first-line ALIMTA plus cisplatin for locally
advanced or metastatic nonsquamous NSCLC.
ALIMTA is not indicated for treatment of patients with squamous
cell NSCLC. Myelosuppression is usually the dose-limiting toxicity
with ALIMTA therapy.
Important Safety Information for ALIMTA® (pemetrexed for
injection)
What is the most important information that I should know
about ALIMTA?
ALIMTA can suppress bone marrow
function, which may cause low blood cell counts.
ALIMTA may not be appropriate for some patients.
If you are allergic to ALIMTA, tell your doctor because you
should not receive it.
If you have liver or kidney problems, be sure to tell your
doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may
not be right for you.
It is very important to take the following medications prior to
and during your treatment with ALIMTA to lower your chances of
harmful side effects:
- You must take folic acid every day by mouth beginning 7 days
before your first dose of ALIMTA. You must keep taking folic acid
every day during the time you are being treated with ALIMTA, and
every day for 21 days after you receive your last dose of
ALIMTA.
- Your doctor will give you vitamin B12 injections
while you are getting treatment with ALIMTA. You will get your
first vitamin B12 injection one week before your first
dose of ALIMTA, and then about every 9 weeks during treatment.
- Your doctor will prescribe a medicine called a "corticosteroid"
which you must take the day before, the day of, and the day after
each treatment with ALIMTA to reduce rash.
You will have regular blood tests before and during your
treatment with ALIMTA. Your doctor may adjust your dose of ALIMTA
or delay your treatment based on the results of your blood test and
on your general condition.
What should I tell my doctor before receiving
ALIMTA?
If you think you are pregnant, are planning
to become pregnant, or are nursing, please tell your healthcare
team. ALIMTA may harm your unborn or nursing baby. Your physician
may advise you to use effective contraception (birth control) to
prevent pregnancy while you are being treated with ALIMTA.
Tell your doctor if you are taking other medicines,
including prescription and nonprescription medicines, vitamins, and
herbal supplements. ALIMTA and other medicines may affect each
other, causing serious side effects. Especially, tell your doctor
if you are taking medicines called "nonsteroidal anti-inflammatory
drugs" (NSAIDs) for pain or swelling.
What are the possible side effects of ALIMTA?
Most patients taking ALIMTA will have side effects. Sometimes it is
not always possible to tell whether ALIMTA, another medicine, or
the cancer itself is causing these side effects.
Call your doctor right away if you have a fever, chills,
diarrhea, or mouth sores. These symptoms could mean you have an
infection, which may be severe and could lead to death.
The most common side effects of ALIMTA when given alone or in
combination with cisplatin are:
- Stomach upset, including nausea, vomiting, diarrhea, or
constipation. You can obtain medicines to help control some of
these symptoms. Call your doctor if you get any of these
symptoms.
- Low blood cell counts:
- Low red blood cells. Low red blood cells may make you
feel tired, get tired easily, appear pale, and become short of
breath.
- Low white blood cells. Low white blood cells may give
you a greater chance for infection. If you have a fever
(temperature above 100.4°F) or other signs of infection, call your
doctor right away.
- Low platelets. Low platelets give you a greater chance
for bleeding. Your doctor will do blood tests to check your blood
counts before and during treatment with ALIMTA.
- Tiredness. You may feel tired or weak for a few days
after your ALIMTA treatments. If you have severe weakness or
tiredness, call your doctor.
- Redness or sores in your mouth, throat, on your lips or in
the tube that connects your throat and stomach (esophagus). You
may get redness or sores in your mouth, throat, on your lips, or in
your esophagus (stomatitis, pharyngitis, esophagitis) or you may
feel pain or have difficulty when drinking or swallowing food.
These symptoms may happen a few days after ALIMTA treatment. Talk
with your doctor if you get any of these symptoms.
- Loss of appetite. You may lose your appetite and lose
weight during your treatment. Talk to your doctor if this is a
problem for you.
- Rash. You may get a rash or itching during treatment.
These reactions usually appear between treatments with ALIMTA and
usually go away before the next treatment. Skin reactions or rashes
that include blistering or peeling may be severe and could lead to
death. Call your doctor if you have any of these symptoms.
Talk with your doctor, nurse, or pharmacist about any side
effect that bothers you or that doesn't go away.
These are not all the side effects of ALIMTA. For more
information, ask your doctor, nurse, or pharmacist.
How is ALIMTA given?
ALIMTA is slowly infused (injected) into a vein. The injection
or infusion will last about 10 minutes. You will usually receive
ALIMTA once every 21 days (3 weeks).
For more information about all of the side effects of ALIMTA,
please talk with your healthcare team, see the Patient Prescribing
Information and full Prescribing Information accompanying this
booklet, visit www.ALIMTA.com, or call 1-800-545-5979.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
PM_CON_ISI_All_17OCT2012
About Lilly Oncology
For more than fifty years,
Lilly has been dedicated to delivering life-changing medicines and
support to people living with cancer and those who care for them.
Lilly is determined to build on this heritage and continue making
life better for all those affected by cancer around the world. To
learn more about Lilly's commitment to people with cancer, please
visit www.LillyOncology.com.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to make life
better for people around the world. We were founded more than a
century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
newsroom.lilly.com/social-channels. (P-LLY)
Merck's Focus on Cancer
Our goal is to
translate breakthrough science into innovative oncology medicines
to help people with cancer worldwide. At Merck Oncology, 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. For more information about our oncology
clinical trials, visit www.merck.com/clinicaltrials.
About Merck
Today's Merck is 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 and connect with us on Twitter, Facebook, YouTube and
LinkedIn.
Lilly Forward-Looking Statement
This press
release contains "forward-looking statements" (as that term is
defined in the United States Private Securities
Litigation Reform Act of 1995) regarding the research collaboration
between Lilly and Merck evaluating pemetrexed and pembrolizumab.
This press release reflects Lilly's current beliefs. However, there
are substantial risks and uncertainties in the process of drug
research, development and commercialization. Among other risks,
there can be no guarantee that these investigational combination
regimens will receive regulatory approval, or, if approved, will
achieve intended benefits or become commercially successful. For
further discussion of these and other risks and uncertainties that
could cause actual results to differ materially from Lilly's
expectations, please see the company's latest Forms 10-K and 10-Q
filed with the U.S. Securities and Exchange Commission. Except
as required by law, Lilly undertakes no duty to update
forward-looking statements for events occurring after the date of
this release.
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 2014
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 the Medication Guide for KEYTRUDA at
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf
CONTACTS:
Merck
Pamela
Eisele: (267) 305-3558 (media)
Teri Loxam: (908) 740-1986
(investors)
Justin Holko: (908) 740-1879
(investors)
Lilly
Karen
Glowacki: (317) 370-1177 (Lilly)
Neil Hochman: (212) 453-2067
(TogoRun)
Logo -
http://photos.prnewswire.com/prnh/20031219/LLYLOGO
Logo - http://photos.prnewswire.com/prnh/20151118/289197LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/lilly-and-merck-expand-immuno-oncology-collaboration-with-phase-iii-nonsquamous-non-small-cell-lung-cancer-trial-300181622.html
SOURCE Eli Lilly and Company