Lilly Reports Top-Line Results from CYRAMZA® (ramucirumab) Phase 3 Study in First-Line Advanced Gastric Cancer
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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