Date: October 15, 2012
For Release: October 15, 2012, 8:00 a.m. EDT
Contact: Tracy Henrikson (Lilly Oncology) Neil Hochman (TogoRun)
908-243-9945 (office) 212-453-2067 (office)
609-240-3902 (mobile) 516-784-9089 (mobile)
Email: tracy.henrikson@imclone.com Email: n.hochman@togorun.com
Lilly Announces Positive Results for Ramucirumab
as Single Agent in Phase III Gastric Cancer Trial
INDIANAPOLIS, October 15, 2012 - Eli Lilly and Company (NYSE:
LLY) today announced that the REGARD trial, a Phase III study of
ramucirumab (IMC-1121B) in patients with metastatic gastric cancer,
met its primary endpoint of improved overall survival and also
showed prolonged progression-free survival. This trial is the first
Phase III data read-out for ramucirumab.
The REGARD trial compared ramucirumab and best supportive care
to placebo and best supportive care as a second-line treatment in
patients with metastatic gastric and gastroesophageal junction
cancers. The most frequent adverse reaction (any grade) occurring
at a higher rate on the ramucirumab arm was hypertension (12%).
Other adverse reactions (>5%) occurring at a higher rate on the
ramucirumab arm compared to the placebo arm were diarrhea and
headache.
"We are pleased with this data of ramucirumab used as
monotherapy in a second-line setting in this difficult-to-treat
disease. It reinforces our confidence in the ramucirumab
development program, in which we currently have six Phase III
studies ongoing in five tumor types - breast, colorectal, gastric,
hepatocellular and lung cancer," said Richard Gaynor, M.D., vice president, product
development and medical affairs for Lilly Oncology.
REGARD is one of two ramucirumab Phase III studies in gastric
cancer. RAINBOW, a Phase III trial of ramucirumab in combination
with paclitaxel, completed patient enrollment last month.
Lilly plans to present data from the REGARD trial at an upcoming
scientific meeting and will discuss submission plans with
regulatory authorities.
Notes to Editor
About the REGARD trial
The REGARD trial is a Phase III randomized, double-blinded study
of ramucirumab and best supportive care (BSC) versus placebo and
BSC in the treatment of metastatic gastric or gastroesophageal
junction adenocarcinoma following disease progression on first-line
platinum- or fluoropyrimidine-containing combination therapy. The
primary endpoint of the REGARD trial is overall survival and
secondary endpoints include: progression-free survival; proportion
of participants who are progression-free at week 12; proportion of
participants with objective response, or objective response rate;
duration of response; and safety.
About the RAINBOW trial
The RAINBOW trial is a Phase III study of ramucirumab and
paclitaxel compared to placebo and paclitaxel as a second-line
treatment in patients with metastatic gastric cancer (including
adenocarcinomas of the gastroesophageal junction), refractory to or
progressive after first-line therapy with platinum and
fluoropyrimidine. The primary endpoint of the RAINBOW trial is
overall survival and secondary endpoints include: progression-free
survival; time to progressive disease; best overall response;
objective response; and safety.
About Ramucirumab
Ramucirumab is a fully human IgG1 monoclonal antibody receptor
antagonist designed to bind the extracellular domain of vascular
endothelial growth factor (VEGF) receptor-2, thereby blocking the
interaction of VEGF ligands (VEGF-A, VEGF-C, and VEGF-D) and
inhibiting receptor activation. VEGF receptor-2 is considered a
primary mediator of angiogenesis. When activated by VEGF ligands,
VEGF receptor-2 promotes endothelial cell proliferation and
survival, migration, and vascular permeability.
Ramucirumab, which Lilly gained through its 2008 acquisition of
ImClone Systems, is being investigated in clinical trials as
monotherapy and in combination with other anticancer therapies for
the treatment of multiple types of cancer. It is in late-stage
clinical evaluation for the treatment of breast, colorectal,
gastric, hepatocellular and lung cancer.
About Gastric Cancer
Gastric cancer is fourth most common cancer in the world,1 with
approximately 989,600 new cases and 738,000 deaths annually.2
Stomach cancer is much more common in less developed
countries.3
Gastric cancer is a disease in which cancer cells form in the
lining of the stomach. It develops slowly, usually over many years
and often goes undetected.4 As the stomach cancer advances, it can
travel through the bloodstream and spread to organs such as the
liver, lungs and bones.5
The most common type of stomach cancer is called adenocarcinoma,
which starts from one of the common cell types found in the lining
of the stomach.6 Other types include: lymphoma, gastrointestinal
stromal tumor and carcinoid tumor.5
For more information on gastric cancer, please visit
www.lillyoncologynewsroom.com.
About Lilly Oncology
For more than four decades, Lilly Oncology, a division of Eli
Lilly and Company, has been dedicated to delivering innovative
solutions that improve the care of people living with cancer.
Because no two cancer patients are alike, Lilly Oncology is
committed to developing novel treatment approaches. To learn more
about Lilly's commitment to cancer, please visit
www.LillyOncology.com
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of pharmaceutical products by applying the latest
research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered
in Indianapolis, Ind., Lilly
provides answers - through medicines and information - for some of
the world's most urgent medical needs. Additional information about
Lilly is available at www.lilly.com.
P-LLY
# # #
This press release contains forward-looking statements about the
potential of ramucirumab as a treatment of various cancers and
reflects Lilly's current beliefs. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
There is no guarantee that future studies will be positive or that
ramucirumab will receive regulatory approvals or prove to be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements.
1 Globocan 2008 Cancer Fact Sheet. Stomach Cancer Incidence and
Mortality Worldwide in 2008.
http://globocan.iarc.fr/factsheets/cancers/stomach.asp. (Accessed:
October 11, 2012).
2 Jemal A, Bray F, Center MM, et al. Global cancer statistics.
CA Cancer J Clin 2011; 61:69.
3 American Cancer Society, "Learn About Cancer: What are the Key
Statistics about Stomach Cancer?" Updated: January 18, 2012; http://www.cancer.org/Cancer/
StomachCancer/DetailedGuide/stomach-cancer-key-statistics.
(Accessed: October 11, 2012).
4 American Cancer Society, "Learn About Cancer: Stomach Cancer,"
Updated: January 18, 2012;
http://www.cancer.org/Cancer/StomachCancer/index. (Accessed:
October 11, 2012).
5 American Cancer Society, "Learn About Cancer: What is Stomach
Cancer? Topics," Updated: January
18,2012; http://www.cancer.org/Cancer/StomachCancer/
DetailedGuide/stomach-cancer-what-is-stomach-cancer. (Accessed:
October 11, 2012).
6 National Center for Biotechnology Information, "Gastric
Cancer," Updated: December 15, 2011;
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001270/). (Accessed:
October 11, 2012).
