Lilly Oncology Focused on Pharmacogenomics at AACR Annual Meeting
April 15 2007 - 10:00AM
PR Newswire (US)
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 )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Christine Van Marter of Eli Lilly
and Company, +1-317-651-1473, or cell, +1-317-554-7923
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