Lilly Reports Additional Top-Line Results from CYRAMZA® (ramucirumab) Phase 3 RANGE Study in Advanced or Metastatic Urothelial Cancer
Lilly Reports Additional Top-Line Results from CYRAMZA® (ramucirumab) Phase 3 RANGE Study in Advanced or Metastatic Urothelial Cancer
Significant improvement in primary endpoint of progression-free survival previously reported; Improvement in objective response rate observed; Positive trend in overall survival did not reach statistical significance
INDIANAPOLIS, April 20, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced additional results from its global, randomized, double-blind, placebo-controlled Phase 3 RANGE trial evaluating CYRAMZA(®) (ramucirumab) in combination with docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. A positive trend was seen in the secondary endpoint of overall survival (OS) which did not reach statistical significance. An improvement in objective response rate (ORR) was observed.
Lilly previously announced that the trial met its primary endpoint of investigator-assessed progression-free survival (PFS); those results were presented at the European Society for Medical Oncology (ESMO) 2017 Congress and simultaneously published in The Lancet.(1) RANGE is the only Phase 3 study to demonstrate superior PFS compared to chemotherapy in a post-platinum setting in advanced urothelial carcinoma. Additionally, RANGE is the first Phase 3 trial to show the benefit of targeting angiogenesis in urothelial carcinoma.
No new safety signals were observed. The safety profile observed in the RANGE study was consistent with what was seen previously in this trial and what has been previously observed for CYRAMZA. The efficacy and safety results will be submitted for presentation at a future medical meeting.
"People with advanced urothelial carcinoma who experience disease progression urgently need treatment options that can control the disease - to help stop or slow the cancer from growing and spreading," said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. "Although this study didn't reach statistical significance for overall survival, we are encouraged by the totality of the RANGE results and look forward to reviewing the data with internal and external experts to determine next steps."
Lilly sincerely appreciates and thanks the patients, investigators and clinical trial sites for their participation in and support of this study.
Lilly remains committed to the investigation and use of CYRAMZA in other tumor types, including those in which it has already demonstrated a Phase 3 overall survival benefit - stomach, non-small cell lung, colorectal and liver cancer.
Notes to Editors
About the RANGE Study
The RANGE trial, which enrolled 530 patients globally, is a randomized, double-blind study designed to evaluate the safety and efficacy of CYRAMZA and docetaxel versus placebo and docetaxel in patients with locally advanced or unresectable or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. The trial includes: 1) patients whose disease progressed following adjuvant and/or neoadjuvant therapy; 2) patients whose disease progressed following first-line therapy for metastatic disease; and 3) patients who had received prior platinum-based and immune checkpoint inhibitor regimens. The trial's primary endpoint is investigator-assessed progression-free survival, and other secondary endpoints include overall survival, objective response rate, disease control rate and patient-reported outcomes.
About Urothelial Cancer
Urothelial cancer includes carcinomas that arise in the urothelial or transitional cells that line the urinary collecting system, including the bladder, which is the most common site for this type of tumor. Other potential primary sites of this cancer include the renal pelvis, ureter and urethra. Bladder cancer accounts for the majority of all urothelial carcinoma.
Worldwide, bladder cancer ranks ninth in the topmost common cancers overall,(2) and the ninth leading cause of cancer-related deaths, afflicting approximately 430,000 people per year and resulting in more than 165,000 deaths.(3) The global incidence of bladder cancer increased 11 percent from 2008 to 2012. In the U.S., bladder cancer is the sixth most common and deadly cancer,(4) with an estimated 81,190 new cases and 17,240 deaths expected in 2018.(5)
Generally, this is an aggressive disease and, unfortunately, despite recently approved therapies, the majority of patients who have disease progression will eventually succumb to their cancer.
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.
CYRAMZA is being investigated in a broad global development program that has enrolled more than 12,000 patients across more than 70 trials worldwide. These include several studies investigating CYRAMZA in combination with other anti-cancer therapies for the treatment of multiple tumor types.
CYRAMZA 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. CYRAMZA 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 2018. 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 RANGE trial and CYRAMZA as a potential treatment for patients with urothelial carcinoma 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 CYRAMZA will receive regulatory approval for urothelial carcinoma or any other tumor type 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.
Refer to: Tracy Henrikson; tracy.henrikson@lilly.com; 609-240-3902
(media)
Kevin Hern; hern_kevin_r@lilly.com; 317-277-1838 (investors)
__________________________________________
(1) Petrylak DP, et al. Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients with Locally Advanced or Metastatic Urothelial Carcinoma after Platinum-based Therapy (RANGE): A Randomised, Double-Blind, Phase 3 Trial. The Lancet. 2017;390(10109):2266 - 2277.
(2) World Cancer Research Fund International. "Bladder cancer statistics." Accessed April 19, 2018. Available at: http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/bladder-cancer-statistics.
(3) World Health Organization. "GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide 2012." Accessed April 19, 2018. Available at: http://globocan.iarc.fr/Pages/fact_sheets_population.aspx.
(4) National Institute of Health National Cancer Institute Surveillance, Epidemiology, and End Results Program. "Cancer Stat Facts: Bladder Cancer." Accessed April 19, 2018. Available at: https://seer.cancer.gov/statfacts/html/urinb.html.
(5) American Cancer Society. "Key Statistics for Bladder Cancer." Accessed April 19, 2018. Available at: http://www.cancer.org/cancer/bladdercancer/detailedguide/bladder-cancer-key-statistics.
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