Lilly Oncology Focused on Pharmacogenomics at AACR Annual Meeting

Los Angeles (ots/PRNewswire) -

- Lilly Oncology to present more than a dozen studies designed to
better predict patient outcomes

Delivering on its commitment to relentless progress in cancer
care; Lilly Oncology will present 17 studies at the 2007 American
Association for Cancer Research (AACR) Annual Meeting in Los Angeles
from April 14-18, 2007. Many of the studies -- which investigate
ALIMTA(R) (pemetrexed for injection); GEMZAR(R) (gemcitabine HCl for
injection), enzastaurin and other products in Lilly's pipeline are
aimed at utilizing pharmacogenomic information such as biomarkers to
enhance treatment and improve patient outcomes. Biomarkers are
genetic indicators that help predict how patients will respond to
certain therapies.

"Lilly Oncology shares the commitment of the American Association
for Cancer Research to use innovative research as a true catalyst in
the fight against cancer," said Richard Gaynor, M.D., vice president,
cancer research and global oncology platform leader at Lilly. "The
goal of the Lilly Oncology research program is to investigate our
current medications, and those in our pipeline, to find the right
medication, at the right dose at the right time for patients."

Lilly Oncology's newest product, ALIMTA, is the foundation of
eight studies being presented at AACR and is currently being
investigated in several global Phase III trials -- JMDB in 1st-line
metastatic non-small cell lung cancer (NSCLC), JMEN as a maintenance
therapy in metastatic NSCLC, in the GALES trial for the treatment of
small cell lung cancer, and the global Phase III SPINNAKER trial for
the treatment of head and neck cancer. ALIMTA is also being studied
in locally advanced and adjuvant NSCLC, ovarian and gastric cancers.
ALIMTA is a standard-of-care in the treatment of malignant pleural
mesothelioma (MPM) and second-line non-small cell lung cancer.

GEMZAR, which celebrated its 10th anniversary as a marketed
product for patients in the United States last year, forms the basis
of two trials being presented at AACR. GEMZAR is approved in the
treatment of pancreatic, NSCLC, breast and ovarian cancers in the
United States. In addition, outside of the US, several countries have
the additional indication in metastatic bladder, cervical and biliary
tract cancers.

Enzastaurin is an investigational oral, serine threonine kinase
inhibitor which selectively targets the PKC-(beta) and PI3/AKT
signaling pathways and is the subject of seven studies being
presented at AACR. Enzastaurin is currently being investigated in a
global Phase III PRELUDE trial for the treatment of diffuse large
B-cell lymphoma, the most common type of non-Hodgkin's lymphoma.
Enzastaurin is also being evaluated in Phase II studies across
several tumor types including: breast, colon, non-small cell lung,
pancreas, ovarian and prostate cancers.

In partnership with the AACR, Lilly Oncology will also recognize
innovative and collaborative research with the sponsorship and
presentation of the first-ever Team Science Award and the annual
G.H.A. Clowes Memorial Award.

The most common adverse events (grades 3/4) with ALIMTA in
combination with cisplatin for the treatment of patients with MPM
were neutropenia (24%); leukopenia (16%); anemia (6%);
thrombocytopenia (5%); infection without neutropenia (2%); fatigue
(17%); thrombosis/embolism (6%); nausea (12%); vomiting (11%);
dyspnea (11%); and chest pain (9%). The most common clinically
relevant adverse events (all grades) were fatigue (80%);
thrombosis/embolism (7%); nausea (84%); vomiting (58%); constipation
(44%); anorexia (35%); stomatitis/pharyngitis (28%); diarrhea (26%);
dyspnea (66%); chest pain (40%); and rash (22%).

The most common adverse events (grades 3/4) with ALIMTA for the
treatment of patients with NSCLC were anemia (8%); leukopenia (5%);
neutropenia (5%); thrombocytopenia (2%); infection without
neutropenia (6%); fatigue (16%); thrombosis/embolism (3%); cardiac
ischemia (3%); anorexia (5%); dyspnea (18%); and chest pain (7%). The
most common clinically relevant adverse events (all grades) were
fatigue (87%); anorexia (62%); nausea (39%); constipation (30%);
vomiting (25%); diarrhea (21%); stomatitis/pharyngitis (20%); dyspnea
(72%); chest pain (38%); neuropathy/sensory (29%); infection without
neutropenia (23%); and rash (17%).

The most severe adverse events (grades 3/4) with GEMZAR plus
paclitaxel for the treatment of patients with MBC were neutropenia
(48%); alopecia (18%); leukopenia (11%); anemia (7%); fatigue (7%);
thrombocytopenia (6%); ALT elevation (6%); and neuropathy-sensory
(6%). The most common adverse events (all grades) were nausea (50%);
fatigue (40%); myalgia (33%); and vomiting (29%).

The most severe adverse events (grades 3/4) with GEMZAR for the
first-line treatment of patients with pancreatic cancer were
neutropenia (24%-26%); alkaline phosphatase elevation (16%-20%); AST
elevation (12%-17%); nausea/vomiting (12%-13%); ALT elevation
(10%-11%); anemia (10%); leukopenia (9%-10%); thrombocytopenia
(8%-10%); bilirubin elevation (4%-8%); and pain (2%-7%). The most
common adverse events (all grades) were AST (72%-78%); alkaline
phosphatase (71%-77%); anemia (65%-73%); ALT (72%); leukopenia
(64%-71%); nausea and vomiting (64%-71%); neutropenia (61%-62%);
thrombocytopenia (36%-47%); pain (10%-42%); fever (30%-38%);
proteinuria (10%-32%); constipation (10%-31%); diarrhea (24%-30%);
rash (24%-28%); and bilirubin (16%-26%).

The most severe adverse events (grades 3/4) with GEMZAR plus
cisplatin for the first-line treatment of patients with NSCLC were
neutropenia (57%-64%); thrombocytopenia (50%-55%); leukopenia
(29%-46%); anemia (22%-25%); nausea (27%); vomiting (23%);
nausea/vomiting (39%); neuromotor (12%); hypomagnesemia (7%);
neurohearing (6%); creatinine elevation (5%); alopecia (1%-13%); and
dyspnea (1%-7%). The most common adverse events (all grades) were
paresthesias (38%); hyperglycemia (30%); infection (18%-28%); and
constipation (17%-28%).

The most severe adverse events (grades 3/4) with GEMZAR plus
carboplatin for the treatment of patients with advanced ovarian
cancer were neutropenia (71%), thrombocytopenia (35%), leukopenia
(53%), anemia (28%), nausea (6%), vomiting (6%), and constipation
(7%). The most common adverse events (all grades) were RBC
transfusion (38%), alopecia (49%), neuropathy/sensory (29%), nausea
(69%), fatigue (40%), vomiting (46%), diarrhea (25%), and
constipation (42%).

See complete Warnings, Precautions, Adverse Reactions, Dosage and
Administration sections in the accompanying full Prescribing
Information for safety and dosing guidelines.

Enzastaurin administration is associated with fatigue, diarrhea,
nausea, decreased platelets, cough, vomiting, transaminase elevation,
dyspnea, peripheral edema, and dizziness. Further testing in Phase
III versus a placebo will provide a more complete look at the side
effect profile for enzastaurin.

O-LLY

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ots Originaltext: Eli Lilly and Company
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Contact:
Christine Van Marter of Eli Lilly and Company, +1-317-651-1473, or
cell, +1-317-554-7923/ Photo: NewsCom:
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