Date: October 17, 2012
For Immediate Release
Contact: Carla Cox, Lilly Neil Hochman, TogoRun
317-651-4017 (office) 212-453-2067 (office)
317-473-4368 (mobile) 516-784-9089 (mobile)
Email: cox_carla_l@lilly.com Email: n.hochman@togorun.com
ALIMTA® EXTENDS SURVIVAL IN CONTINUATION MAINTENANCE SETTING FOR
SPECIFIC LUNG
CANCER PATIENTS
FDA Approves New Use of ALIMTA (pemetrexed for injection) in the
Continuation
Maintenance Setting for Advanced Nonsquamous Non-Small Cell Lung
Cancer
INDIANAPOLIS, October 17, 2012 - Eli Lilly and Company (NYSE:
LLY) announced today that patients may receive ALIMTA® (pemetrexed
for injection) as a maintenance therapy following first-line ALIMTA
plus cisplatin for locally advanced or metastatic nonsquamous
non-small cell lung cancer (NS NSCLC). The FDA approved the label
inclusion of Phase III data that demonstrated progression-free and
overall survival advantages in the continuation maintenance setting
for these patients.
Appropriate patients can now start with ALIMTA plus cisplatin
and continue with ALIMTA in the maintenance setting in advanced or
metastatic NS NSCLC. ALIMTA is indicated for the maintenance
treatment of patients with locally advanced or metastatic NS NSCLC
whose disease has not progressed after four cycles of
platinum-based first-line chemotherapy. ALIMTA is not indicated for
patients with squamous-cell NSCLC. Myelosuppression is usually the
dose-limiting toxicity with ALIMTA therapy.
"Continuation maintenance" involves continuing one of the same
medicines prescribed in first-line treatment as maintenance
therapy, in an effort to extend survival. It is the most recent
addition to a new paradigm of maintenance treatment for advanced
nonsquamous non-small cell lung cancer. Prior to the use of
maintenance treatment, physicians typically treated a patient with
four to six cycles of chemotherapy and then waited until the
disease returned or worsened before resuming treatment.
"The approval provides patients and physicians with a new
regimen that has demonstrated an improvement in overall survival. A
survival benefit was previously established for ALIMTA for the
first-line treatment of advanced nonsquamous non-small cell lung
cancer in combination with cisplatin, and now as a single-agent for
continuation maintenance treatment," said Richard Gaynor, M.D., vice president, product
development and medical affairs for Lilly Oncology. "This is the
first study to show a survival advantage for continuation
maintenance, and it reinforces the role of ALIMTA in treating
patients with advanced nonsquamous NSCLC."
In October 2011, the European
Commission granted approval for the use of ALIMTA as a single agent
for continuation maintenance in patients with advanced NS NSCLC
based on progression-free survival and preliminary overall
survival. On September 21, 2012, the
Committee for Medicinal Products for Human Use (CHMP) in the
European Union issued a positive opinion for a label update for
ALIMTA in the continuation maintenance setting for certain patients
with advanced nonsquamous non-small cell lung cancer after initial
treatment with ALIMTA plus cisplatin.
The FDA and European Commission approvals were based on results
from PARAMOUNT, a global, multicenter, double-blind Phase III
trial, the final results of which were shared in an oral
presentation at the American Society of Clinical Oncology (ASCO)
annual meeting in Chicago, Ill. on
June 4, 2012. PARAMOUNT was the first
study to evaluate the first-line use of ALIMTA plus cisplatin
therapy followed immediately by the use of ALIMTA as a single-agent
in the continuation maintenance setting.
A total of 939 patients with advanced nonsquamous NSCLC were
enrolled in the study and received ALIMTA (500 mg/m2 on day one of
a 21-day cycle) in combination with cisplatin (75 mg/m2) induction
therapy. All patients received vitamin B12, folic acid and
dexamethasone.
Patients whose disease had not progressed during the ALIMTA plus
cisplatin induction and who had an ECOG performance status of 0-1
(n=539) were randomized two-to-one to receive ALIMTA maintenance
(500 mg/m2 on day one of a 21-day cycle) plus best supportive care
(n=359) or placebo plus best supportive care (n=180) until disease
progression. Of the patients whose disease had not progressed
during ALIMTA plus cisplatin induction therapy and who were
randomized to receive maintenance therapy, 44% versus 42% achieved
a complete or partial response to induction therapy and 53% versus
53% had stable disease after induction treatment in the ALIMTA and
placebo arms, respectively.
Final results of the PARAMOUNT trial demonstrated a
statistically significant 22 percent reduction in the risk of death
(HR=0.78; 95% CI: 0.64-0.96; p=0.02) with ALIMTA, compared to
placebo. This reduction in the risk of death resulted in an
improved median overall survival from the time patients were
randomized of 13.9 months median for patients receiving ALIMTA,
compared to 11.0 months median for patients on the placebo arm.
Median progression-free survival measured from randomization was
4.1 months on the ALIMTA arm as compared to 2.8 months on the
placebo arm with a hazard ratio of 0.62. Stated another way, the
study showed that patients on the ALIMTA continuation maintenance
arm had a 38 percent improvement of survival without disease
worsening, compared to the placebo arm.
The most severe adverse reactions (grades 3-4) with ALIMTA as a
single agent versus placebo, respectively, for these patients in
the maintenance setting were anemia (4.8% vs 0.6%); neutropenia
(3.9% vs 0%); fatigue (4.5% vs 0.6%).
Common adverse reactions (all grades) with ALIMTA as a single
agent versus placebo, respectively, were anemia (15% vs 4.8%);
neutropenia (9% vs 0.6%); fatigue (18% vs 11%); nausea (12% vs
2.4%); vomiting (6% vs 1.8%); mucositis/ stomatitis (5% vs 2.4%);
edema (5% vs 3.6%).
U.S. ALIMTA Approvals
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.
ALIMTA is not indicated for treatment of patients with squamous
cell NSCLC. Myelosuppression is usually the dose-limiting toxicity
with ALIMTA therapy.
About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer has long been the most common cancer in the world,
representing nearly 13 percent of all new cancers and causing
nearly 1.4 million deaths annually. About 85 percent of all lung
cancers are NSCLC. The liver, bones and brain are potential targets
if the cancerous cells spread to other areas in the body.
NSCLC comprises a group of histologies or tumor types
differentiated by cellular structure. Nonsquamous histology
includes adenocarcinoma and large cell carcinoma, which account for
more than half of all NSCLC diagnoses, as well as histologies
classified as "other."
About Lilly Oncology
For more than four decades, Lilly Oncology, a division of Eli
Lilly and Company, has been dedicated to delivering innovative
solutions that improve the care of people living with cancer.
Because no two cancer patients are alike, Lilly Oncology is
committed to developing novel treatment approaches. To learn more
about Lilly's commitment to cancer, please visit
www.LillyOncology.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of pharmaceutical products by applying the latest
research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered
in Indianapolis, Ind., Lilly
provides answers - through medicines and information - for some of
the world's most urgent medical needs.
P-LLY
Consumer Important Safety Information (ISI)
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 see the Patient Prescribing Information at
http://pi.lilly.com/us/alimta-ppi.pdf, the full Prescribing
Information at http://pi.lilly.com/us/alimta-pi.pdf, 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
# # #
This press release contains forward-looking statements about the
potential of ALIMTA for the treatment of non-small cell lung cancer
and reflects Lilly's current beliefs. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of development, commercialization, and
regulatory review. There is no guarantee that the product will
continue to be commercially successful. For further discussion of
these and other risks and uncertainties, see Lilly's filings with
the United States Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.
PM79473 10/2012 © 2012, Lilly USA, LLC. ALL RIGHTS RESERVED.
ALIMTA® is a registered trademark of Eli Lilly and Company.
NOTE: The second-line NSCLC indication was approved under 21 CFR
314.500 et seq (Subpart H - Accelerated Approval of New Drugs for
Serious or Life-Threatening Illnesses) using a surrogate
endpoint.
World Health Organization International Agency for Research in
Cancer, GLOBOCAN 2008, Section of Cancer Information,
http://globocan.iarc.fr/factsheets/cancers /lung.asp, (Accessed
June 20, 2012).
American Cancer Society, "What Is Non-Small Cell Lung Cancer?,"
February 17, 2012, American Cancer
Society, http://www.cancer.org/Cancer/
LungCancer-Non-SmallCell/DetailedGuide/
non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer,
(Accessed June 20, 2012).
American Cancer Society, "What Is Non-Small Cell Lung Cancer?,"
February 17, 2012, American Cancer
Society, http://www.cancer.org/Cancer/
LungCancer-Non-SmallCell/DetailedGuide/
non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer,
(Accessed June 20, 2012).
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.
www.lilly.com
