BN003644 15 de abril de 2007 09:00 HORALOCAL
Lilly Oncology to present more than a dozen studies designed to
better predict patient outcomes
LOS ANGELES, April 15 /PRNewswire-FirstCall/ -- 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
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
SOURCE Eli Lilly and Company
04/15/2007
CONTACT: Christine Van Marter of Eli Lilly and Company,
+1-317-651-1473, or cell, +1-317-554-7923
First Call Analyst:
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