Targeted, Oral Agent Enzastaurin Shows Favorable Results in Late-Stage Lung C

Susan

<span class="postbody"><br/><br/>Study Supports Lilly's Commitment to Advances in Lung Cancer Treatment <br/><br/>CHICAGO, June 2 /PRNewswire-FirstCall/ -- Enzastaurin, an <br/>investigational targeted, oral agent under development by Eli Lilly and <br/>Company, showed encouraging results in treating patients with late-stage <br/>non-small cell lung cancer (NSCLC), according to data presented today at <br/>the 43rd Annual Meeting of the American Society of Clinical Oncology <br/>(ASCO). <br/>The data presented were gathered from a multicenter Phase II study of <br/>enzastaurin as a second- or third-line treatment of NSCLC (ASCO Abstract <br/>#7543(i)). The rationale for the study was based on enzastaurin's unique <br/>mechanism of action as a serine/threonine kinase inhibitor, which is <br/>believed to suppress signaling through the PKC-beta and PI3K/AKT pathways. <br/>Historically, over-expression and activity of PKC-beta and PI3K/AKT have <br/>been associated with poor prognosis and treatment resistance in NSCLC. The <br/>primary objective of the study was progression-free survival at six months. <br/>Secondary endpoints were safety and overall survival at 12 months. <br/>"These data in NSCLC shed new light on the potential versatility of <br/>this agent," said Richard Gaynor, M.D., vice president, cancer research and <br/>global oncology platform leader for Lilly. "Our objective with enzastaurin <br/>is to continue investigating the efficacy and safety of this unique <br/>molecule in order to determine the diseases where enzastaurin could have <br/>the most positive impact on patients." <br/>In the study, patients received 500 mg of oral enzastaurin, once daily, <br/>until disease progression or unacceptable toxicity occurred. In the 54 <br/>patients enrolled, the median progression-free survival was 1.9 months (95% <br/>Confidence Interval: 1.7-1.9) and the progression-free survival rate at six <br/>months was 14% (95% CI: 4.4%-23.6%). The median overall survival was 9.9 <br/>months (95% CI: 6.5-14.6). The overall survival rate at 12 months was 46.3% <br/>(95% CI: 32.1%-60.5%). The most common toxicity was fatigue. Additional <br/>toxicities observed included ataxia (n=1), thromboembolism (n=1), anemia <br/>(n=1) and dizziness. <br/>"Based on the encouraging survival and tolerability data gathered thus <br/>far, further evaluation of enzastaurin in NSCLC, as a single agent or in <br/>combination, is warranted," said chief investigator for the study, Gerold <br/>Bepler, M.D., Ph.D., chief of thoracic oncology at the H. Lee Moffitt <br/>Cancer Center and Research Institute in Tampa, Florida. <br/>Additional data presented at ASCO this year examined studies of <br/>enzastaurin in breast cancer, first-line glioblastoma, ovarian and <br/>pancreatic cancers, as well as other solid tumors. Specifically, the data <br/>included: testing enzastaurin on cell signaling, proliferation and <br/>apoptosis in breast cancer, testing in Phase I/II with radiation <br/>combination therapy for first- line treatment of glioblastoma multiforme, a <br/>pre-clinical study on ovarian chemo-resistant cancer cell lines, testing <br/>for growth suppression in pancreatic cancer, as well as dosage testing on <br/>other solid tumors. <br/>"Through a constant stream of innovation, we remain committed to <br/>fighting cancer," said Gaynor. "By aggressively studying enzastaurin across <br/>multiple tumor types, we believe that we will find appropriate and <br/>innovative uses for this targeted therapy to help benefit patients." <br/>Enzastaurin <br/>Enzastaurin is an oral, serine threonine kinase inhibitor which <br/>selectively targets the PKC-beta and PI3K/AKT signaling pathways. By <br/>blocking these key pathways frequently over-expressed in a wide variety of <br/>cancers, enzastaurin suppresses tumor cell proliferation, induces tumor <br/>cell death and inhibits tumor-induced angiogenesis. Enzastaurin is being <br/>evaluated in a Phase III trial (currently enrolling patients) as a <br/>maintenance therapy for the treatment of diffuse large B-cell lymphoma <br/>(DLBCL), as well as being evaluated in several Phase II studies across a <br/>variety of more common tumor types including: breast, colon, lung, ovarian <br/>and prostate cancers. More details on the enzastaurin Phase III trial, as <br/>well as information on global recruitment sites, may be found at <br/><a href="http://www.clinicaltrials.gov,/" target="_blank"><font color="#000066">http://www.clinicaltrials.gov,</font></a>
                <a href="http://www.lillytrials.com/" target="_blank"><font color="#000066">http://www.lillytrials.com</font></a> or by calling 1-877-CTLilly <br/>(1-877-285-4559). <br/>About Lilly Oncology, a Division of Eli Lilly and Company <br/>For more than four decades, Lilly Oncology has been collaborating with <br/>cancer researchers to deliver innovative treatment choices and valuable <br/>programs to patients and their physicians. Inspired by courageous patients <br/>living with cancer, Lilly Oncology is providing treatments that are <br/>considered global standards of care and developing a broad portfolio of <br/>novel targeted therapies to accelerate the pace and progress of cancer <br/>care. To learn more about Lilly's commitment to cancer, please visit <br/><a href="http://www.lillyoncology.com./" target="_blank"><font color="#000066">http://www.LillyOncology.com.</font></a>
                <br/>About Eli Lilly and Company <br/>Lilly, a leading innovation-driven corporation, is developing a growing <br/>portfolio of first-in-class and best-in-class pharmaceutical products by <br/>applying the latest research from its own worldwide laboratories and from <br/>collaborations with eminent scientific organizations. Headquartered in <br/>Indianapolis, Ind., Lilly provides answers -- through medicines and <br/>information -- for some of the world's most urgent medical needs. <br/></span>

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