INDIANAPOLIS, June 5, 2018 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced that the U.S. Food and Drug
Administration (FDA) has granted approval for a new indication for
ALIMTA® (pemetrexed for injection) in combination with
carboplatin and KEYTRUDA® (pembrolizumab) for the
initial treatment of patients with metastatic nonsquamous non-small
cell lung cancer (NSCLC), irrespective of PD-L1 expression status.
Under the FDA's accelerated approval regulations, this indication
is approved based on tumor response rate and progression-free
survival (PFS). Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
the confirmatory trials.
Merck (known as MSD outside the U.S. and Canada) received accelerated approval for the
combination of pembrolizumab with ALIMTA and carboplatin in
May 2017. This is the first and only
combination of chemotherapy and immunotherapy to earn FDA approval
for the first-line treatment of metastatic nonsquamous NSCLC. This
indication, now included in the ALIMTA prescribing information, is
based on data from Merck's KEYNOTE-021 study, Cohort G1.
"Lung cancer is the leading cause of cancer death in the U.S.,
and this approval represents the power of rational combinations and
collaborations in bringing new treatments to these patients," said
Sue Mahony, Ph.D., senior vice
president and president of Lilly Oncology. "ALIMTA has been a
long-standing, first-line treatment for locally advanced or
metastatic nonsquamous non-small cell lung cancer. This combination
with pembrolizumab continues to build on the robust body of
evidence for ALIMTA in lung cancer."
The KEYNOTE-021, Part 2, Cohort G1, study included 123
previously untreated patients with locally advanced or metastatic
nonsquamous NSCLC with no epidermal growth factor receptor (EGFR)
or anaplastic lymphoma kinase (ALK) genomic tumor aberrations and
irrespective of PD-L1 expression status. The triplet combination of
ALIMTA and carboplatin with pembrolizumab (n=60) demonstrated a
statistically significant improvement in objective response rate
(ORR) versus ALIMTA plus carboplatin alone (n=63) (55% vs 29%; all
responses were partial) (estimated difference, 26%; 95% confidence
interval [CI], range of 42-68 for triplet and range of 18-41 for
ALIMTA plus carboplatin; P=0.0032), and PFS (HR=0.53; 95% CI,
0.31-0.91, P=0.0205). Median PFS was 13.0 months for triplet and
8.9 months for ALIMTA plus carboplatin (range of 8.3-NE for triplet
and 4.4-10.3 for ALIMTA plus carboplatin).
The labeling for ALIMTA contains warnings and precautions for
myelosuppression and increased risk of myelosuppression without
vitamin supplementation, renal failure, bullous and exfoliative
skin toxicity, interstitial pneumonitis, radiation recall,
increased risk of toxicity with ibuprofen in patients with renal
impairment and also embryo-fetal toxicity. Initiate supplementation
with oral folic acid and intramuscular vitamin B12 prior to and for
21 days after the last dose of ALIMTA. Determine creatinine
clearance before each dose and periodically monitor renal function
during treatment. Withhold ALIMTA in patients with a creatinine
clearance of less than 45 mL/minute. The dosage of ALIMTA should be
modified according to the full prescribing information when
experiencing certain adverse reactions. The dosage of ibuprofen
needs to be modified in patients with mild to moderate renal
impairment receiving ALIMTA. Advise patients of the potential risk
to a fetus and to use effective contraception. Please see Important
Safety Information below and full Prescribing Information for more
information.
About KEYNOTE-021
KEYNOTE-021, conducted by Merck, is
a multi-cohort Phase 1/2 study evaluating the safety and
preliminary efficacy of pembrolizumab with ALIMTA and carboplatin,
immunotherapy or EGFR-targeted therapy for advanced nonsquamous
NSCLC. Two of the eight cohorts included ALIMTA. Cohort G1 (n=123)
is a Phase 2, randomized evaluation of the
pembrolizumab-ALIMTA-carboplatin combination. The combination
therapy is pembrolizumab at a fixed dose of 200 mg administered as
an intravenous infusion over 30 minutes every three weeks in
combination with ALIMTA 500 mg/m2 administered as an IV
infusion over 10 minutes every three weeks and carboplatin AUC 5
mg/mL/min every three weeks for four cycles.
In the KEYNOTE-021, Cohort G1, trial, safety was evaluated in 59
patients who received pembrolizumab with ALIMTA and carboplatin and
62 patients who received ALIMTA and carboplatin alone. KEYNOTE-021
was not designed to demonstrate a statistically significant
difference in adverse reaction rates for pembrolizumab with ALIMTA
and carboplatin, as compared to ALIMTA and carboplatin alone.
ALIMTA was discontinued for adverse reactions in nine percent of
patients receiving pembrolizumab with ALIMTA and carboplatin.
The most common adverse reaction resulting in discontinuation of
ALIMTA (≥2%) was acute kidney injury (3.4%). Adverse reactions
leading to interruption of ALIMTA occurred in 36 percent of
patients; the most common (≥2%) were fatigue (9%), neutrophil count
decreased (9%), anemia (7%), dyspnea (3.4%) and pneumonitis
(3.4%).
About Lung Cancer
Lung cancer is the leading cause of
cancer death in the U.S. and most other countries,
killing nearly 1.6 million people worldwide each
year.1 In the U.S., lung cancer is responsible
for approximately 26 percent of all cancer deaths, more than those
from breast, colon and prostate cancers
combined.2 Stage IV NSCLC is a very
difficult-to-treat cancer and the prognosis is poor for metastatic
NSCLC.3 NSCLC is much more common than other types
of lung cancer and accounts for about 85 percent of all lung cancer
cases.4 For those people afflicted with NSCLC,
about 70 percent have nonsquamous cell carcinoma, while about 30
percent have squamous cell
carcinoma.4 Approximately half of patients with
metastatic NSCLC who begin first-line therapy will move on to
second-line treatment.5
About ALIMTA® (pemetrexed for injection)
In 2004, ALIMTA received consecutive approvals: it was the first
agent to be approved in combination with cisplatin as an initial
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 treatment of
patients with locally advanced or metastatic NSCLC after prior
treatment.
In 2008, ALIMTA, in combination with cisplatin, was approved as
an initial chemotherapy treatment for locally advanced or
metastatic NSCLC for patients with nonsquamous histology. At the
time of this initial treatment approval, the FDA also approved a
change to the indication for subsequent treatment. As a result,
ALIMTA was also indicated as a single agent for the treatment of
patients with recurrent, metastatic nonsquamous NSCLC after prior
therapy.
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 initial chemotherapy.
In 2012, ALIMTA was approved by the FDA as maintenance therapy
for locally advanced or metastatic NSCLC, following initial
ALIMTA-plus-cisplatin treatment for locally advanced or metastatic
nonsquamous NSCLC.
In 2018, ALIMTA received an additional indication for the
combination with carboplatin plus pembrolizumab in first-line
treatment for metastatic nonsquamous NSCLC, irrespective of PD-L1
expression status. This approval was based on Merck's KEYNOTE-021,
Cohort G1, study.
ALIMTA is not indicated for treatment of patients with squamous
cell NSCLC.
Indications for ALIMTA® (pemetrexed for
injection)
ALIMTA (pemetrexed for injection) is indicated in
combination with cisplatin therapy for the initial treatment of
patients with locally advanced or metastatic nonsquamous non-small
cell lung cancer.
ALIMTA is indicated as a single agent for the maintenance
treatment of patients with locally advanced or metastatic
nonsquamous non-small cell lung cancer whose disease has not
progressed after four cycles of platinum-based first-line
chemotherapy.
ALIMTA is indicated as a single agent for the treatment of
patients with recurrent, metastatic nonsquamous non-small cell lung
cancer after prior chemotherapy.
ALIMTA is indicated in combination with carboplatin and
pembrolizumab for the initial treatment of patients with metastatic
nonsquamous non-small cell lung cancer. This indication is approved
under accelerated approval based on tumor response rate and
progression-free survival. Continued approval for this indication
may be contingent upon verification and description of clinical
benefit in the confirmatory trials.
Limitation of Use: ALIMTA is not indicated for the
treatment of patients with squamous cell non-small cell lung
cancer.
ALIMTA in combination with cisplatin is indicated for the
initial treatment of patients with malignant pleural mesothelioma
whose disease is unresectable or who are otherwise not candidates
for curative surgery.
IMPORTANT SAFETY INFORMATION FOR ALIMTA®
(pemetrexed for injection)
ALIMTA is contraindicated in patients who have a history
of severe hypersensitivity reaction to pemetrexed.
ALIMTA can cause severe myelosuppression resulting in a
requirement for transfusions and which may lead to neutropenic
infection. The risk of myelosuppression is increased in patients
who do not receive vitamin supplementation. Prior to treatment
with ALIMTA, patients must be instructed to initiate
supplementation with oral folic acid. Intramuscular injections of
vitamin B12 are also required prior to ALIMTA treatment.
Folic acid and vitamin B12 supplementation should be
continued during treatment and for 21 days after the last dose of
ALIMTA as they may reduce the severity of treatment-related
hematologic and gastrointestinal toxicities. Obtain a complete
blood count at the beginning of each cycle. Do not administer
ALIMTA until the ANC is at least 1500 cells/mm3 and
platelet count is at least 100,000 cells/mm3.
Permanently reduce ALIMTA in patients with an ANC of less than 500
cells/mm3 or platelet count of less than 50,000
cells/mm3 in previous cycles. In Studies JMDB and JMCH,
among patients who received vitamin supplementation, incidence of
Grade 3-4 neutropenia was 15% and 23%, the incidence of Grade 3-4
anemia was 6% and 4%, and incidence of Grade 3-4 thrombocytopenia
was 4% and 5%, respectively. In Study JMCH, 18% of patients in the
ALIMTA arm required red blood cell transfusions compared to 7% of
patients in the cisplatin arm. In Studies JMEN, PARAMOUNT,
and JMEI, where all patients received vitamin supplementation,
incidence of Grade 3-4 neutropenia ranged from 3% to 5%, and
incidence of Grade 3-4 anemia ranged from 3% to 5%.
ALIMTA can cause severe, and sometimes fatal, renal
toxicity. Determine creatinine clearance before each dose and
periodically monitor renal function during treatment with ALIMTA.
The incidences of renal failure in clinical studies in which
patients received ALIMTA with cisplatin were: 2.1% in Study JMDB
and 2.2% in Study JMCH. The incidence of renal failure in clinical
studies in which patients received ALIMTA as a single agent ranged
from 0.4% to 0.6% (Studies JMEN, PARAMOUNT, and JMEI). Withhold
ALIMTA in patients with a creatinine clearance of less than 45
mL/min.
ALIMTA can cause serious and sometimes fatal, bullous,
blistering and exfoliative skin toxicity, including cases
suggestive of Stevens-Johnson Syndrome/Toxic epidermal necrolysis
can occur with ALIMTA. Permanently discontinue ALIMTA for severe
and life-threatening bullous, blistering or exfoliating skin
toxicity.
Serious interstitial pneumonitis, including fatal cases,
can occur with ALIMTA treatment. Withhold ALIMTA for acute onset of
new or progressive unexplained pulmonary symptoms such as dyspnea,
cough, or fever pending diagnostic evaluation. If pneumonitis is
confirmed, permanently discontinue ALIMTA.
Radiation Recall can occur with ALIMTA in patients who
have received radiation weeks to years previously. Monitor patients
for inflammation or blistering in areas of previous radiation
treatment. Permanently discontinue ALIMTA for signs of radiation
recall.
Exposure to ALIMTA is increased in patients with mild to
moderate renal impairment who take concomitant ibuprofen,
increasing the risks of adverse reactions of ALIMTA. In
patients with creatinine clearances between 45 mL/min and 79
mL/min, avoid administration of ibuprofen for 2 days before, the
day of, and 2 days following administration of ALIMTA. If
concomitant ibuprofen use cannot be avoided, monitor patients more
frequently for ALIMTA adverse reactions, including
myelosuppression, renal, and gastrointestinal toxicity.
Based on findings from animal studies and its mechanism of
action, ALIMTA can cause fetal harm when administered
to a pregnant woman. In animal reproduction studies, intravenous
administration of pemetrexed to pregnant mice during the period of
organogenesis was teratogenic, resulting in developmental delays
and increased malformations at doses lower than the recommended
human dose of 500 mg/m2. Advise pregnant women of the
potential risk to the fetus. Advise females of reproductive
potential to use effective contraception during treatment with
ALIMTA and for 6 months after the final dose. Advise males with
female partners of reproductive potential to use effective
contraception during treatment with ALIMTA and for 3 months after
the final dose.
Ibuprofen increases exposure (AUC) of pemetrexed. In patients
with creatinine clearance between 45 mL/min and 79 mL/min. Avoid
administration of ibuprofen for 2 days before, the day of, and 2
days following administration of ALIMTA and monitor patients
more frequently for myelosuppression, renal, and gastrointestinal
toxicity, if concomitant administration of ibuprofen cannot be
avoided.
The most severe adverse reactions (grades 3-4) occurring
in fully vitamin supplemented patients with locally advanced or
metastatic nonsquamous non-small cell lung cancer (NSCLC) receiving
ALIMTA in combination with cisplatin versus gemcitabine in
combination with cisplatin for initial treatment (JMDB),
respectively, were neutropenia (15% vs 27%); fatigue (7% vs 5%);
nausea (7% vs 4%); vomiting (6% vs 6%); anemia (6% vs 10%);
thrombocytopenia (4% vs 13%); anorexia (2% vs 1%); creatinine
elevation (1% vs 1%); diarrhea (1% vs 2%); stomatitis/pharyngitis
(1% vs 0%); and constipation (1% vs 0%).
The most common adverse reactions (all grades) occurring
in ≥5% fully vitamin supplemented patients with
locally advanced or metastatic nonsquamous non-small cell lung
cancer (NSCLC) receiving ALIMTA in combination with cisplatin
versus gemcitabine in combination with cisplatin for initial
treatment (JMDB), respectively, were nausea (56% vs 53%);
fatigue (43% vs 45%); vomiting (40% vs 36%); anemia (33% vs 46%);
neutropenia (29% vs 38%); anorexia (27% vs 24%); constipation (21%
vs 20%); stomatitis/pharyngitis (14% vs 12%); alopecia (12% vs
21%); diarrhea (12% vs 13%); thrombocytopenia (10% vs 27%);
creatinine elevation (10% vs 7%), sensory neuropathy (9% vs 12%);
taste disturbance (8% vs 9%); rash/desquamation (7% vs 8%); and
dyspepsia/heartburn (5% vs 6%).
The most severe adverse reactions (grades 3-4) occurring
in patients with non-progressive locally advanced or metastatic
nonsquamous non-small cell lung cancer (NSCLC) receiving ALIMTA
as a single agent versus placebo as maintenance treatment
(JMEN), respectively, following non-ALIMTA containing
platinum-based induction therapy were anemia (3% vs 1%);
neutropenia (3% vs 0%); fatigue (5% vs 1%); nausea (1% vs 1%);
anorexia (2% vs 0%); infection (2% vs 0%); mucositis/stomatitis (1%
vs 0%); diarrhea (1% vs 0%); and sensory neuropathy (1% vs 0%).
The most common adverse reactions (all grades) occurring
in ≥5% patients with non-progressive locally
advanced or metastatic nonsquamous non-small cell lung cancer
(NSCLC) receiving ALIMTA as a single agent versus placebo as
maintenance treatment (JMEN), respectively, following
non-ALIMTA containing platinum-based induction therapy were fatigue
(25% vs 11%); nausea (19% vs 6%); anorexia (19% vs 5%); anemia (15%
vs 6%); increased rash/desquamation (10% vs 3%); ALT (10% vs 4%);
sensory neuropathy (9% vs 4%); vomiting (9% vs 1%); increased AST
(8% vs 4%); mucositis/stomatitis (7% vs 2%); neutropenia (6% vs
0%); diarrhea (5% vs 3%); and infection (5% vs 2%).
The most severe adverse reactions (grades 3-4) occurring
in patients with non-progressive locally advanced or metastatic
nonsquamous non-small cell lung cancer (NSCLC) receiving ALIMTA
as a single agent versus placebo as maintenance treatment
(PARAMOUNT), respectively, following ALIMTA plus cisplatin
induction therapy were anemia (4.8% vs 0.6%); fatigue (4.5% vs
0.6%); neutropenia (3.9% vs 0%); nausea (0.3% vs 0%); and
mucositis/stomatitis (0.3% vs 0%).
The most common adverse reactions (all grades) occurring
in ≥5% patients with non-progressive locally
advanced or metastatic nonsquamous non-small cell lung cancer
(NSCLC) receiving ALIMTA as a single agent versus placebo as
maintenance treatment (PARAMOUNT), respectively, following
ALIMTA plus cisplatin induction therapy were fatigue (18% vs 11%);
anemia (15% vs 4.8%); nausea (12% vs 2.4%); neutropenia (9% vs
0.6%); vomiting (6% vs 1.8%); mucositis/stomatitis (5% vs 2.4%);
and edema (5% vs 3.6%).
The most severe adverse reactions (grades 3-4) occurring in
fully supplemented patients with recurrent metastatic
nonsquamous non-small cell lung cancer (NSCLC) receiving ALIMTA
as a single agent versus docetaxel as 2nd-line treatment after
prior chemotherapy (JMEI), respectively, were neutropenia (5%
vs 40%); fatigue (5% vs 5%); anemia (4% vs 4%); nausea (3% vs 2%);
anorexia (2% vs 3%); vomiting (2% vs 1%); thrombocytopenia (2% vs
0%); increased ALT (2% vs 0%); increased AST (1% vs 0%); and
stomatitis/pharyngitis (1% vs 1%).
The most common adverse reactions (all grades) occurring
in ≥5% of fully supplemented patients with
recurrent metastatic nonsquamous non-small cell lung cancer (NSCLC)
receiving ALIMTA as a single agent versus docetaxel as 2nd-line
treatment after prior chemotherapy (JMEI), respectively, were
fatigue (34% vs 36%); nausea (31% vs 17%); anorexia (22% vs 24%);
anemia (19% vs 22%); vomiting (16% vs 12%); stomatitis/pharyngitis
(15% vs 17%); rash/desquamation (14% vs 6%); diarrhea (13% vs 24%);
neutropenia (11% vs 45%); fever (8% vs 8%); thrombocytopenia (8% vs
1%); increased ALT (8% vs 1%); pruritus (7% vs 2%); increased AST
(7% vs 1%); constipation (6% vs 4%); and alopecia (6% vs 38%).
The most severe adverse reactions (grades 3-4) occurring in
the fully supplemented subgroup of patients with malignant
pleural mesothelioma (MPM) receiving ALIMTA in combination with
cisplatin versus cisplatin alone (JMCH), respectively, were
neutropenia (23% vs 3%); nausea (12% vs 6%); vomiting (11% vs 4%);
fatigue (10% vs 9%); thrombocytopenia (5% vs 0%); dehydration (4%
vs 1%); anemia (4% vs 0%); diarrhea (4% vs 0%);
stomatitis/pharyngitis (3% vs 0%); creatinine elevation (1% vs 1%);
anorexia (1% vs 1%); constipation (1% vs 1%); dyspepsia (1% vs 0%);
sensory neuropathy (0% vs 1%); rash (1% vs 0%); and creatinine
clearance decrease (1% vs 2%).
The most common adverse reactions (all grades) occurring
in ≥5% of the fully supplemented subgroup of
patients with malignant pleural mesothelioma (MPM) receiving
ALIMTA in combination with cisplatin versus cisplatin alone
(JMCH), respectively, were nausea (82% vs 77%); vomiting (57%
vs 50%); neutropenia (56% vs 13%); fatigue (48% vs 42%); anemia
(26% vs 10%); thrombocytopenia (23% vs 9%); stomatitis/pharyngitis
(23% vs 6%); anorexia (20% vs 14%); diarrhea (17% vs 8%);
creatinine clearance decreased (16% vs 18%); rash (16% vs 5%);
constipation (12% vs 7%); creatinine elevation (11% vs 10%);
alopecia (11% vs 6%); sensory neuropathy (10% vs 10%);
conjunctivitis (5% vs 1%); dyspepsia (5% vs 1%); dehydration (7% vs
1%); and taste disturbance (8% vs 6%).
The most severe adverse reactions (grades 3-4) occurring
in patients with metastatic nonsquamous non-small cell lung cancer
(NSCLC) receiving ALIMTA and carboplatin in combination with
pembrolizumab versus ALIMTA and carboplatin for initial treatment
(KEYNOTE-021), respectively, were fatigue (3.4% vs 0%); dyspnea
(3.4% vs 0%); nausea (1.7% vs 0%); vomiting (1.7% vs 0%); diarrhea
(1.7% vs 1.6%); rash (1.7% vs 1.6%); constipation (0% vs 1.6%);
headache (0% vs 1.6%); and arthralgia (0% vs 1.6%).
The most common adverse reactions (all grades) occurring
in patients with metastatic nonsquamous non-small cell lung cancer
(NSCLC) receiving ALIMTA and carboplatin in combination with
pembrolizumab versus ALIMTA and carboplatin for initial treatment
(KEYNOTE-021), respectively, were fatigue (71% vs 50%); nausea
(68% vs 56%); constipation (51% vs 37%); rash (42% vs 21%);
vomiting (39% vs 27%); dyspnea (39% vs 21%); diarrhea (37% vs 23%);
decreased appetite (31% vs 23%); headache (31% vs 16%); cough (24%
vs 18%); dizziness (24% vs 16%); insomnia (24% vs 15%); pruritus
(24% vs 4.8%); peripheral edema (22% vs 18%); dysgeusia (20% vs
11%); alopecia (20% vs 3.2%) upper respiratory tract infection (20%
vs 3.2%) and arthralgia (15% vs 24%).
There is no information regarding the presence of pemetrexed or
its metabolites in human milk, the effects on the breastfed infant,
or the effects on milk production. Because of the potential for
serious adverse reactions in breastfed infants from ALIMTA, advise
women not to breastfeed during treatment with ALIMTA and for one
week after last dose.
ALIMTA may impair fertility in males of reproductive
potential. It is not known whether these effects on fertility
are reversible.
The safety and effectiveness of ALIMTA in pediatric
patients have not been established. Adverse reactions observed
in pediatric patients studied were similar to those observed in
adults.
ALIMTA is primarily excreted by the kidneys. Decreased renal
function results in reduced clearance and greater exposure (AUC) to
ALIMTA compared with patients with normal renal function. No
dose is recommended for patients with creatinine clearance less
than 45 mL/min.
The incidences of Grade 3-4 anemia, fatigue, thrombocytopenia,
hypertension, and neutropenia were higher in patients 65 years
of age and older as compared to younger patients: in at least
one of five randomized clinical trials.
Please see full Prescribing Information.
PM_HCP_ISI_All_04-Jun-2018
About Lilly Oncology
For more than 50 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
www.lilly.com/newsroom/social-channels. P-LLY
PP-PM-US-0487 06/2018 © Lilly USA, LLC 2018. ALL RIGHTS RESERVED.
ALIMTA® is a registered trademark owned by or
licensed to Eli Lilly and Company, its subsidiaries, or
affiliates.
KEYTRUDA® is a registered trademark of Merck Sharp
& Dohme Corp., a subsidiary of Merck & Co., Inc.
Lilly Forward-Looking
Statement
This press release contains
forward-looking statements (as that term is defined in the Private
Securities Litigation Reform Act of 1995) about ALIMTA as a
potential treatment for patients with 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. Among other things, there can be no guarantee
that ALIMTA will receive additional regulatory approvals or be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's most recent Form 10-K and
Form 10-Q filings with the United States Securities and
Exchange Commission. Except as required by
law, Lilly undertakes no duty to update forward-looking
statements to reflect events after the date of this
release.
1 International Agency for Research on Cancer.
GLOBOCAN 2012. Lung Cancer Estimated Incidence, Mortality and
Prevalence Worldwide in
2012. http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx.
Accessed April 24, 2018.
2 American Cancer Society. Cancer Facts and Figures
2017. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2017/cancer-facts-and-figures-2017.pdf.
Accessed April 24, 2018.
3 American Cancer Society. Non-Small Cell Lung Cancer
Survival Rates, by
Stage. http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-survival-rates.
Updated May 16, 2016. Accessed April 24, 2018.
4 American Cancer Society. What is non-small cell lung
cancer? http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer.
Updated May 16, 2016. Accessed April 24, 2018.
5 Stinchcombe TE, Socinski MA. Considerations for
Second-Line Therapy of Non-Small Cell Lung Cancer. The
Oncologist. 2008;13:28-36.
Refer
to:
|
Tracy Henrikson;
tracy.henrikson@lilly.com; 609-240-3902 (media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (investors)
|
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