LOS ANGELES, April 15 /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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Christine Van Marter of Eli Lilly and Company, +1-317-651-1473, or cell, +1-317-554-7923/ Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO/ PRN Photo Desk, photodesk@prnewswire.com
