INDIANAPOLIS, Dec. 8, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced top-line results from its Phase
3 RAINFALL study of CYRAMZA® (ramucirumab) in
combination with cisplatin and capecitabine or 5-FU
(5-fluorouracil) in the first-line treatment of patients with
HER2-negative metastatic gastric or gastroesophageal junction (GEJ)
adenocarcinoma. The trial met its primary endpoint of
progression-free survival (PFS) but did not improve overall
survival (OS), a secondary endpoint. The results will be submitted
for presentation at a future medical meeting.
The safety profile observed in the RAINFALL study was consistent
with what has been previously observed for ramucirumab. Grade
≥3 adverse events occurring at a rate of five percent or greater
and that were higher on the
ramucirumab-plus-cisplatin-and-capecitabine/5-FU arm compared to
the placebo-plus-cisplatin-and-capecitabine/5-FU arm
were hypertension, hand-foot syndrome, and fatigue.
"While we hoped that the positive PFS outcome would have
translated into an OS benefit, these RAINFALL results highlight the
challenges associated with improving outcomes for people with
advanced gastric cancer," said Levi
Garraway, M.D., Ph.D., senior vice president, global
development and medical affairs, Lilly Oncology. "This is
underscored by the fact that there have been no major advances over
standard chemotherapy in the first-line HER2-negative gastric
cancer treatment setting in the last decade."
Dr. Garraway added, "Lilly is deeply committed to patients with
this aggressive disease, and CYRAMZA remains a standard of care in
the second-line treatment paradigm for advanced gastric cancer
patients around the world. We thank the patients, their caregivers
and investigators for their support of and participation in the
RAINFALL study."
The company does not intend to seek regulatory approval based on
the results of the RAINFALL study. The outcome of RAINFALL does not
have any impact on current ramucirumab approvals.
After becoming the first FDA-approved agent to treat advanced
gastric cancer after prior chemotherapy in 2014 based on two
pivotal Phase 3 studies, ramucirumab is now a standard of care in
this setting around the world. This is supported by global and
local treatment guidelines, including NCCN, JGCA and ESMO.
Overall, there have been six positive Phase 3 trials of
ramucirumab to date. Previously completed Phase 3 studies of
ramucirumab have demonstrated benefit in advanced forms of gastric,
non-small cell lung and colorectal cancer – three of the world's
leading causes of cancer-related death. An ongoing Phase 3 trial in
advanced urothelial carcinoma has also met its primary endpoint of
PFS; those initial data were presented at the ESMO 2017 Congress
and OS data are expected in mid-2018. Two other ongoing Phase 3
studies of ramucirumab – in hepatocellular carcinoma and
EGFR-positive non-small cell lung cancer – are ongoing, with
expected data readouts in 2018.
Notes to Editors
About RAINFALL
RAINFALL is a global, randomized,
double-blinded, placebo-controlled Phase 3 study of ramucirumab in
combination with cisplatin and capecitabine as a first-line
treatment in patients with metastatic gastric or gastroesophageal
junction (GEJ) adenocarcinoma. Study participants unable to take
capecitabine (tablets) were given 5-fluorouracil (5-FU).
Initiated in 2015, the study enrolled 645 patients across 19
countries in North America,
Asia (Japan), Europe and Latin
America. The primary endpoint of the RAINFALL trial is
progression-free survival and key secondary endpoints include:
overall survival; objective response rate; and safety.
About Gastric Cancer
Gastric cancer, also known as stomach cancer, is a major global
health problem. Globally, it is the fifth most common cancer in the
world, with one million new cases annually.1 Gastric
cancer originates in the stomach. Cancer cells typically develop
slowly and symptoms often do not appear until the disease is
advanced and has already spread to other organs such as the liver,
lungs and bones.2,3 Stomach cancer is the third leading
cause of cancer deaths in the world, resulting in 723,000 deaths
each year.1 The five-year survival rate for stomach
cancer is 31 percent and five percent for advanced
cases.4
Stomach cancer is much more common in the Far East than in the
Western world.1 In the U.S., it is estimated that
approximately 28,000 people will be diagnosed with stomach cancer
and nearly 11,000 people will die from this type of cancer in
2017.5 In Japan, the
incidence of stomach cancer is high. Of all cancers in Japan, stomach cancer is the second most
common and it is the second-leading cause of cancer-related deaths,
affecting approximately 108,000 people and killing approximately
52,000.
About Angiogenesis and VEGF Protein
Angiogenesis is
the process of making new blood vessels. In a person with cancer,
angiogenesis creates new blood vessels that give a tumor its own
blood supply, allowing it to grow and spread.
Some tumors create proteins called VEGF. These proteins attach
to the VEGF receptors of blood vessel cells causing new blood
vessels to form around the tumors, enabling growth. Blocking the
VEGF protein from linking to the blood vessels helps to inhibit
tumor growth by slowing angiogenesis and the blood supply that
feeds tumors. Of the three known VEGF receptors, VEGF Receptor 2 is
linked most closely to VEGF-induced tumor angiogenesis.
About CYRAMZA® (ramucirumab)
In the U.S.,
CYRAMZA (ramucirumab) is approved for use as a single agent or in
combination with paclitaxel as a treatment for people with advanced
or metastatic gastric (stomach) or gastroesophageal junction (GEJ)
adenocarcinoma whose cancer has progressed on or after prior
fluoropyrimidine- or platinum-containing chemotherapy. It is also
approved in combination with docetaxel as a treatment for people
with metastatic non-small cell lung cancer (NSCLC) whose cancer has
progressed on or after platinum-based chemotherapy. Additionally,
it is approved with FOLFIRI as a treatment for people with
metastatic colorectal cancer (mCRC) whose cancer has progressed on
or after therapy with bevacizumab, oxaliplatin, and a
fluoropyrimidine.
Ramucirumab is being investigated in a broad global development
program that has enrolled more than 10,000 patients across more
than 70 trials worldwide. There are several studies underway or
planned to investigate ramucirumab as a single agent and in
combination with other anti-cancer therapies for the treatment of
multiple tumor types.
Ramucirumab is an antiangiogenic therapy. It is a vascular
endothelial growth factor (VEGF) Receptor 2 antagonist that
specifically binds and blocks activation of VEGF Receptor 2 by
blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and
VEGF-D. Ramucirumab inhibited angiogenesis in an in vivo
animal model.
INDICATIONS
Gastric Cancer
CYRAMZA, as a single agent or in
combination with paclitaxel, is indicated for the treatment of
patients with advanced or metastatic, gastric or gastroesophageal
junction (GEJ) adenocarcinoma with disease progression on or after
prior fluoropyrimidine- or platinum-containing chemotherapy.
Non-Small Cell Lung Cancer
CYRAMZA, in combination
with docetaxel, is indicated for the treatment of patients with
metastatic non-small cell lung cancer (NSCLC) with disease
progression on or after platinum-based chemotherapy. Patients with
epidermal growth factor receptor (EGFR) or anaplastic lymphoma
kinase (ALK) genomic tumor aberrations should have disease
progression on FDA-approved therapy for these aberrations prior to
receiving CYRAMZA.
Colorectal Cancer
CYRAMZA, in combination with
FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is
indicated for the treatment of patients with metastatic colorectal
cancer (mCRC) with disease progression on or after prior therapy
with bevacizumab, oxaliplatin, and a fluoropyrimidine.
IMPORTANT SAFETY INFORMATION FOR CYRAMZA
WARNING:
HEMORRHAGE, GASTROINTESTINAL PERFORATION, AND
IMPAIRED
WOUND HEALING
Hemorrhage:
CYRAMZA increased the risk of hemorrhage and
gastrointestinal
hemorrhage, including severe and sometimes fatal hemorrhagic
events. Permanently
discontinue CYRAMZA in patients who experience severe bleeding.
Gastrointestinal
Perforation: CYRAMZA can increase the risk of gastrointestinal
perforation, a potentially fatal event. Permanently discontinue
CYRAMZA in patients who
experience a gastrointestinal
perforation.
Impaired Wound Healing: Impaired wound healing can occur with
antibodies inhibiting
the VEGF pathway. Discontinue CYRAMZA therapy in patients with
impaired wound
healing. Withhold CYRAMZA prior to surgery and discontinue CYRAMZA
if a patient
develops wound healing complications.
|
Warnings and Precautions
Hemorrhage
- In study 1, which evaluated CYRAMZA as a single agent in
advanced gastric cancer, the incidence of severe bleeding was 3.4%
for CYRAMZA and 2.6% for placebo. In study 2, which evaluated
CYRAMZA plus paclitaxel in advanced gastric cancer, the incidence
of severe bleeding was 4.3% for CYRAMZA plus paclitaxel and 2.4%
for placebo plus paclitaxel. Patients with gastric cancer receiving
nonsteroidal anti-inflammatory drugs (NSAIDs) were excluded from
enrollment in studies 1 and 2. In study 3, which evaluated CYRAMZA
plus docetaxel in metastatic non-small cell lung cancer (NSCLC),
the incidence of severe bleeding was 2.4% for CYRAMZA plus
docetaxel and 2.3% for placebo plus docetaxel. Patients with NSCLC
receiving therapeutic anticoagulation or chronic therapy with
NSAIDs or other antiplatelet therapy other than once-daily aspirin
or with radiographic evidence of major airway or blood vessel
invasion or intratumor cavitation were excluded from study 3. In
study 4, which evaluated CYRAMZA plus FOLFIRI in metastatic
colorectal cancer, the incidence of severe bleeding was 2.5% for
CYRAMZA plus FOLFIRI and 1.7% for placebo plus FOLFIRI. Permanently
discontinue CYRAMZA in patients who experience severe
bleeding.
Arterial Thromboembolic Events (ATEs)
- Serious, sometimes fatal, ATEs including myocardial infarction,
cardiac arrest, cerebrovascular accident, and cerebral ischemia
occurred in clinical trials. Permanently discontinue CYRAMZA in
patients who experience a severe ATE.
Hypertension
- An increased incidence of severe hypertension occurred in
patients receiving CYRAMZA as a single agent (8%) as compared to
placebo (3%), in patients receiving CYRAMZA plus paclitaxel (15%)
as compared to placebo plus paclitaxel (3%), and in patients
receiving CYRAMZA plus docetaxel (6%) as compared to placebo plus
docetaxel (2%), and in patients receiving CYRAMZA plus FOLFIRI
(11%) as compared to placebo plus FOLFIRI (3%). Monitor blood
pressure every 2 weeks or more frequently as indicated during
treatment. Temporarily suspend CYRAMZA for severe hypertension
until medically controlled. Permanently discontinue CYRAMZA if
medically significant hypertension cannot be controlled with
antihypertensive therapy or in patients with hypertensive crisis or
hypertensive encephalopathy.
Infusion-Related Reactions (IRRs)
- Prior to the institution of premedication recommendations
across clinical trials of CYRAMZA, IRRs occurred in 6 out of 37
patients (16%), including 2 severe events. The majority of IRRs
across trials occurred during or following a first or second
CYRAMZA infusion. Monitor patients during the infusion for signs
and symptoms of IRRs in a setting with available resuscitation
equipment. Immediately and permanently discontinue CYRAMZA for
grade 3 or 4 IRRs.
Gastrointestinal Perforations
- Four of 570 patients (0.7%) who received CYRAMZA as a single
agent in advanced gastric cancer clinical trials experienced
gastrointestinal perforation. In study 2, the incidence of
gastrointestinal perforation was 1.2% for CYRAMZA plus paclitaxel
as compared to 0.3% for placebo plus paclitaxel. In study 3, the
incidence of gastrointestinal perforation was 1% for CYRAMZA plus
docetaxel as compared to 0.3% for placebo plus docetaxel. In study
4, the incidence of gastrointestinal perforation was 1.7% for
CYRAMZA plus FOLFIRI and 0.6% for placebo plus FOLFIRI. Permanently
discontinue CYRAMZA in patients who experience a gastrointestinal
perforation.
Impaired Wound Healing
- CYRAMZA has not been studied in patients with serious or
nonhealing wounds. CYRAMZA has the potential to adversely affect
wound healing. Discontinue CYRAMZA therapy in patients with
impaired wound healing. Withhold CYRAMZA prior to surgery. Resume
CYRAMZA following the surgical intervention based on clinical
judgment of adequate wound healing. If a patient develops wound
healing complications during therapy, discontinue CYRAMZA until the
wound is fully healed.
Clinical Deterioration in Child-Pugh B or C Cirrhosis
- Clinical deterioration, manifested by new onset or worsening
encephalopathy, ascites, or hepatorenal syndrome, was reported in
patients with Child-Pugh B or C cirrhosis who received single-agent
CYRAMZA.
Reversible Posterior Leukoencephalopathy Syndrome
(RPLS)
- RPLS has been reported at a rate of <0.1% in clinical
studies with CYRAMZA. Discontinue CYRAMZA in patients who develop
RPLS. Symptoms may resolve or improve within days, although some
patients with RPLS can experience ongoing neurologic sequelae or
death.
Proteinuria Including Nephrotic Syndrome
- In study 4, severe proteinuria occurred more frequently in
patients treated with CYRAMZA plus FOLFIRI compared to patients
receiving placebo plus FOLFIRI. Severe proteinuria was reported in
3% of patients treated with CYRAMZA plus FOLFIRI (including 3 cases
[0.6%] of nephrotic syndrome) compared to 0.2% of patients treated
with placebo plus FOLFIRI. Monitor proteinuria by urine dipstick
and/or urinary protein creatinine ratio for the development of
worsening of proteinuria during CYRAMZA therapy. Withhold CYRAMZA
for urine protein levels that are ≥2 g over 24 hours. Reinitiate
CYRAMZA at a reduced dose once the urine protein level returns to
<2 g over 24 hours. Permanently discontinue CYRAMZA for urine
protein levels >3 g over 24 hours or in the setting of nephrotic
syndrome.
Thyroid Dysfunction
- Monitor thyroid function during treatment with CYRAMZA. In
study 4, the incidence of hypothyroidism reported as an adverse
event was 2.6% in the CYRAMZA plus FOLFIRI-treated patients and
0.9% in the placebo plus FOLFIRI-treated patients.
Embryofetal Toxicity
- Based on its mechanism of action, CYRAMZA can cause fetal harm
when administered to pregnant women. Animal models link
angiogenesis, VEGF, and VEGF Receptor 2 (VEGFR2) to critical
aspects of female reproduction, embryofetal development, and
postnatal development. Advise pregnant women of the potential risk
to a fetus. Advise females of reproductive potential to use
effective contraception during treatment with CYRAMZA and for at
least 3 months after the last dose of CYRAMZA.
Most Common Adverse Reactions—Single Agent
- The most commonly reported adverse reactions (all grades; grade
3/4) occurring in ≥5% of patients receiving CYRAMZA and ≥2% higher
than placebo in study 1 were hypertension (16% vs 8%; 8% vs 3%),
diarrhea (14% vs 9%; 1% vs 2%), headache (9% vs 3%; 0% vs 0%), and
hyponatremia (6% vs 2%; 3% vs 1%).
- The most common serious adverse events with CYRAMZA in study 1
were anemia (3.8%) and intestinal obstruction (2.1%). Red blood
cell transfusions were given to 11% of CYRAMZA-treated patients vs
8.7% of patients who received placebo.
- Clinically relevant adverse reactions reported in ≥1% and
<5% of CYRAMZA-treated patients vs placebo in study 1 were:
neutropenia (4.7% vs 0.9%), epistaxis (4.7% vs 0.9%), rash (4.2% vs
1.7%), intestinal obstruction (2.1% vs 0%), and arterial
thromboembolic events (1.7% vs 0%).
- Across clinical trials of CYRAMZA administered as a single
agent, clinically relevant adverse reactions (including grade ≥3)
reported in CYRAMZA-treated patients included proteinuria,
gastrointestinal perforation, and infusion-related reactions. In
study 1, according to laboratory assessment, 8% of CYRAMZA-treated
patients developed proteinuria vs 3% of placebo-treated patients.
Two patients discontinued CYRAMZA due to proteinuria. The rate of
gastrointestinal perforation in study 1 was 0.8% and the rate of
infusion-related reactions was 0.4%.
Most Common Adverse Reactions—Combination With
Paclitaxel
- The most commonly reported adverse reactions (all grades; grade
3/4) occurring in ≥5% of patients receiving CYRAMZA plus paclitaxel
and ≥2% higher than placebo plus paclitaxel in study 2 were
fatigue/asthenia (57% vs 44%; 12% vs 6%), neutropenia (54% vs 31%;
41% vs 19%), diarrhea (32% vs 23%; 4% vs 2%), epistaxis (31% vs 7%;
0% vs 0%), hypertension (25% vs 6%; 15% vs 3%), peripheral edema
(25% vs 14%; 2% vs 1%), stomatitis (20% vs 7%; 1% vs 1%),
proteinuria (17% vs 6%; 1% vs 0%), thrombocytopenia (13% vs 6%; 2%
vs 2%), hypoalbuminemia (11% vs 5%; 1% vs 1%), and gastrointestinal
hemorrhage events (10% vs 6%; 4% vs 2%).
- The most common serious adverse events with CYRAMZA plus
paclitaxel in study 2 were neutropenia (3.7%) and febrile
neutropenia (2.4%); 19% of patients treated with CYRAMZA plus
paclitaxel received granulocyte colony-stimulating factors.
- Adverse reactions resulting in discontinuation of any component
of the CYRAMZA plus paclitaxel combination in 2% or more patients
in study 2 were neutropenia (4%) and thrombocytopenia (3%).
- Clinically relevant adverse reactions reported in ≥1% and
<5% of the CYRAMZA plus paclitaxel-treated patients in study 2
were sepsis (3.1% for CYRAMZA plus paclitaxel vs 1.8% for placebo
plus paclitaxel) and gastrointestinal perforations (1.2% for
CYRAMZA plus paclitaxel vs 0.3% for placebo plus paclitaxel).
Most Common Adverse Reactions—Combination With
Docetaxel
- The most commonly reported adverse reactions (all grades; grade
3/4) occurring in ≥5% of patients receiving CYRAMZA plus docetaxel
and ≥2% higher than placebo plus docetaxel in study 3 were
neutropenia (55% vs 46%; 49% vs 40%), fatigue/asthenia (55% vs 50%;
14% vs 11%), stomatitis/mucosal inflammation (37% vs 19%; 7% vs
2%), epistaxis (19% vs 7%; <1% vs <1%), febrile neutropenia
(16% vs 10%; 16% vs 10%), peripheral edema (16% vs 9%; 0% vs
<1%), thrombocytopenia (13% vs 5%; 3% vs <1%), lacrimation
increased (13% vs 5%; <1% vs 0%), and hypertension (11% vs 5%;
6% vs 2%).
- The most common serious adverse events with CYRAMZA plus
docetaxel in study 3 were febrile neutropenia (14%), pneumonia
(6%), and neutropenia (5%). The use of granulocyte
colony-stimulating factors was 42% in CYRAMZA plus
docetaxel-treated patients versus 37% in patients who received
placebo plus docetaxel.
- In patients ≥65 years of age, there were 18 (8%) deaths on
treatment or within 30 days of discontinuation for CYRAMZA plus
docetaxel and 9 (4%) deaths for placebo plus docetaxel. In patients
<65 years of age, there were 13 (3%) deaths on treatment or
within 30 days of discontinuation for CYRAMZA plus docetaxel and 26
(6%) deaths for placebo plus docetaxel.
- Treatment discontinuation due to adverse reactions occurred
more frequently in CYRAMZA plus docetaxel-treated patients (9%)
than in placebo plus docetaxel-treated patients (5%). The most
common adverse events leading to treatment discontinuation of
CYRAMZA in study 3 were infusion-related reaction (0.5%) and
epistaxis (0.3%).
- For patients with nonsquamous histology, the overall incidence
of pulmonary hemorrhage was 7% and the incidence of grade ≥3
pulmonary hemorrhage was 1% for CYRAMZA plus docetaxel compared to
6% overall incidence and 1% for grade ≥3 pulmonary hemorrhage for
placebo plus docetaxel. For patients with squamous histology, the
overall incidence of pulmonary hemorrhage was 10% and the incidence
of grade ≥3 pulmonary hemorrhage was 2% for CYRAMZA plus docetaxel
compared to 12% overall incidence and 2% for grade ≥3 pulmonary
hemorrhage for placebo plus docetaxel.
- Clinically relevant adverse reactions reported in ≥1% and
<5% of CYRAMZA plus docetaxel-treated patients in study 3 were
hyponatremia (4.8% CYRAMZA plus docetaxel versus 2.4% for placebo
plus docetaxel) and proteinuria (3.3% CYRAMZA plus docetaxel versus
0.8% placebo plus docetaxel).
Most Common Adverse Reactions—Combination With
FOLFIRI
- The most commonly reported adverse reactions (all grades; grade
3/4) occurring in ≥5% of patients receiving CYRAMZA plus FOLFIRI
and ≥2% higher than placebo plus FOLFIRI in study 4 were diarrhea
(60% vs 51%; 11% vs 10%), neutropenia (59% vs 46%; 38% vs 23%),
decreased appetite (37% vs 27%; 2% vs 2%), epistaxis (33% vs 15%;
0% vs 0%), stomatitis (31% vs 21%; 4% vs 2%), thrombocytopenia (28%
vs 14%; 3% vs <1%), hypertension (26% vs 9%; 11% vs 3%),
peripheral edema (20% vs 9%; <1% vs 0%), proteinuria (17% vs 5%;
3% vs <1%), palmar-plantar erythrodysesthesia syndrome (13% vs
5%; 1% vs <1%), gastrointestinal hemorrhage events (12% vs 7%;
2% vs 1%), hypoalbuminemia (6% vs 2%; 1% vs 0%). Twenty percent of
patients treated with CYRAMZA plus FOLFIRI received granulocyte
colony-stimulating factors.
- The most common serious adverse events with CYRAMZA plus
FOLFIRI were diarrhea (3.6%), intestinal obstruction (3.0%), and
febrile neutropenia (2.8%).
- Treatment discontinuation of any study drug due to adverse
reactions occurred more frequently in CYRAMZA plus FOLFIRI-treated
patients (29%) than in placebo plus FOLFIRI-treated patients (13%).
The most common adverse reactions leading to discontinuation of any
component of CYRAMZA plus FOLFIRI as compared to placebo plus
FOLFIRI were neutropenia (12.5% versus 5.3%) and thrombocytopenia
(4.2% versus 0.8%). The most common adverse reactions leading to
treatment discontinuation of CYRAMZA were proteinuria (1.5%) and
gastrointestinal perforation (1.7%).
- Clinically relevant adverse reactions reported in ≥1% and
<5% of CYRAMZA plus FOLFIRI-treated patients in study 4
consisted of gastrointestinal perforation (1.7% CYRAMZA plus
FOLFIRI versus 0.6% for placebo plus FOLFIRI).
- Thyroid-stimulating hormone (TSH) was evaluated in 224 patients
(115 CYRAMZA plus FOLFIRI-treated patients and 109 placebo plus
FOLFIRI-treated patients) with normal baseline TSH levels.
Increased TSH was observed in 53 (46%) patients treated with
CYRAMZA plus FOLFIRI compared with 4 (4%) patients treated with
placebo plus FOLFIRI.
Drug Interactions
- No pharmacokinetic interactions were observed between
ramucirumab and paclitaxel, between ramucirumab and docetaxel, or
between ramucirumab and irinotecan or its active metabolite,
SN-38.
Use in Specific Populations
- Pregnancy: Based on its mechanism of action, CYRAMZA can cause
fetal harm. Animal models link angiogenesis, VEGF, and VEGF
Receptor 2 (VEGFR2) to critical aspects of female reproduction,
embryofetal development, and postnatal development. There are no
available data on CYRAMZA use in pregnant women to inform any
drug-associated risks. No animal studies have been conducted to
evaluate the effect of ramucirumab on reproduction and fetal
development. Advise females of reproductive potential of the
potential risk for maintaining pregnancy, risk to the fetus, and
risk to newborn and pediatric development, and to use effective
contraception during CYRAMZA therapy and for at least 3 months
following the last dose of CYRAMZA.
- Lactation: Because of the potential risk for serious adverse
reactions in nursing infants from ramucirumab, advise women that
breastfeeding is not recommended during treatment with
CYRAMZA.
- Females of Reproductive Potential: Advise females of
reproductive potential that based on animal data CYRAMZA may impair
fertility.
Please see full Prescribing Information for
CYRAMZA, including Boxed Warning for hemorrhage, gastrointestinal
perforation, and impaired wound healing.
RB-P-HCP ISI 16FEB2017
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 newsroom.lilly.com/social-channels.
P-LLY
© Lilly USA, LLC 2017. ALL
RIGHTS RESERVED.
CYRAMZA is a trademark owned by or licensed to Eli Lilly and
Company, its subsidiaries, or affiliates.
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 the
RAINFALL trial and ramucirumab as a potential treatment
for patients with gastric 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 ramucirumab will receive regulatory
approvals or continue to 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 Globocan 2012 Cancer Fact Sheet. Stomach Cancer
Estimated Incidence, Mortality and Prevalence Worldwide in 2012.
http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Accessed
November 29, 2017.
2 American Cancer Society. Signs and symptoms of
stomach cancer. Updated February 10,
2016.
http://www.cancer.org/cancer/stomachcancer/detailedguide/stomachcancer-signs-symptoms.
Accessed November 29, 2017.
3 American Cancer Society. What is stomach cancer?
Updated February 10, 2016.
http://www.cancer.org/cancer/stomachcancer/detailedguide/stomach-cancer-what-is-stomach-cancer.
Accessed November 29, 2017.
4 American Cancer Society. Survival Rates for Stomach
Cancer, by Stage. Available at:
https://www.cancer.org/cancer/stomach-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed November 29, 2017.
5 American Cancer Society. What are the key
statistics about stomach cancer?
http://www.cancer.org/Cancer/StomachCancer/DetailedGuide/stomach-cancer-key-statistics.
Updated May 27, 2014. Accessed
November 29, 2017.
Refer to: Tracy Henrikson;
tracy.henrikson@lilly.com; 609-240-3902 (media)
Phil Johnson;
johnson_philip_l@lilly.com; 317-655-6874
(investors)
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