INDIANAPOLIS, May 28, 2015 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced final results of the Phase III
PROCLAIM trial that will also be discussed in an oral presentation
at the American Society of Clinical Oncology (ASCO) Annual Meeting
in Chicago. PROCLAIM was a
randomized, Phase III superiority study of patients with
locally-advanced, nonsquamous non-small cell lung cancer (NSCLC),
which evaluated Lilly's ALIMTA® (pemetrexed for
injection), in combination with cisplatin with concurrent radiation
followed by maintenance ALIMTA in comparison with etoposide and
cisplatin plus concurrent radiation, followed by consolidation
chemotherapy of the oncologist's choice.
PROCLAIM was the largest study to evaluate the effect of
pemetrexed/platinum plus radiation in this setting. Lilly announced
in 2012 that the study enrollment was halted because an Independent
Data Monitoring Committee projected that the experimental arm of
the study would not meet its primary endpoint of superior overall
survival. As no new safety issues were identified, all patients who
received treatment with the pemetrexed regimen were allowed to
continue their assigned therapy at the discretion of the
investigator and were followed for survival with the final results
now at ASCO.
"Despite the outcome of this trial, ALIMTA is approved in
first-line, maintenance, and second-line therapy for people with
advanced, nonsquamous non-small cell lung cancer," said
Richard Gaynor, M.D., senior vice
president, product development and medical affairs for Lilly
Oncology. "We remain committed to exploring other combinations to
treat patients with non-small cell lung cancer, including studying
ALIMTA with some of the new immuno-oncology therapies in
development."
In the PROCLAIM trial, patients with nonsquamous NSCLC were
treated in the first-line setting with pemetrexed plus cisplatin
and concurrent thoracic radiation therapy (n=283) or etoposide plus
cisplatin and concurrent radiation (n=272). Patients on the
pemetrexed arm received subsequent treatment with additional doses
of single-agent pemetrexed and patients on the etoposide arm
received consolidated chemotherapy – either more
etoposide-cisplatin or vinorelbine-cisplatin or
paclitaxel-carboplatin – as selected by the treating
oncologist.
Those treated on the pemetrexed arm achieved a median overall
survival (OS) of 26.8 months as compared to 25 months for those
treated on the etoposide arm (HR 0.98; 95% CI: 0.79, 1.20;
p=0.831). Median progression-free survival (PFS) was 11.4 months on
the pemetrexed arm versus 9.8 months on the etoposide arm (HR 0.86;
95% CI: 0.71, 1.04; p=0.130) and an overall response rate (ORR) of
35.9 percent on the pemetrexed arm and 33 percent on the etoposide
arm. Grade 3/4 adverse events occurred in 64.0 percent of patients
on the pemetrexed arm with 76.8 percent on the etoposide arm. Grade
3/4 neutropenia/granulocytopenia was lower on the
pemetrexed-cisplatin arm compared to the etoposide-arm (24.4% vs.
44.5%; p<0.0001), as well as rates of pneumonitis/pulmonary
infiltrates (1.8% vs. 2.6%) and esophagitis (15.5% vs. 20.6%).
About ALIMTA®
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.[1]
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 received further approval as "continuation"
maintenance therapy 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)
© Lilly USA, LLC 2015. ALL
RIGHTS RESERVED.
ALIMTA is a trademark owned by or licensed to Eli Lilly and
Company, its subsidiaries, or affiliates.
This press release contains forward-looking statements about
the potential of ALIMTA® (pemetrexed for injection) as a
treatment of nonsquamous 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 and commercialization. There can be no
guarantee that future study results and patient experience will be
consistent with the study findings to date. Among other things,
there can also be no guarantee that ALIMTA will receive regulatory
approval for any future combinations or that it will prove to be
commercially successful for any additional indications. For further
discussion of these and other risks and uncertainties that could
cause actual results to differ 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.
_____________________
|
[1] 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.
|
Refer to: Crystal
Livers-Powers; crystal_livers-powers@lilly.com; (317) 476-4160
(Lilly)
Neil
Hochman; n.hochman@togorun.com; (212) 453-2067
(TogoRun)
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SOURCE Eli Lilly and Company