LEL Lilly(Eli)

 
TIDMLEL 
 
Issue Date: May 14, 2012 
 
Media Alert 
 
Media Contacts: 
 
Amy Sousa (Lilly) Office: (317) 276-8478 Mobile: (317) 997-1481 
 
Neil Hochman (TogoRun) Office: (212) 453-2067 Mobile: (516) 784-9089 
 
           LILLY ONCOLOGY TO DISCLOSE NEW PIPELINE DATA AT ASCO 2012 
 
  Updates on Three of Six Ongoing Phase III Ramucirumab Trialsto Be Presented 
 
INDIANAPOLIS, May 14, 2012 - Eli Lilly and Company (NYSE: LLY) will present 
data from several molecules that make up its clinical oncology pipeline during 
the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) 
held in Chicago, Ill. from June 1 - 5, 2012. 
 
Lilly Oncology has more than 30 molecules in early- and late-stage development 
to treat various types of cancer. The company remains committed to evaluating 
each of its molecules for biomarkers or genetic mutations that can help better 
identify the specific patients who will better respond to these medicines. 
 
Early-Stage Pipeline Results 
 
Lilly early-stage pipeline molecules will be featured at oral presentations at 
ASCO with two first-in-human Phase I studies, one on its oral NOTCH inhibitor 
LY900009 and the other for its oral p38 MAPK inhibitor LY2228820 dimesylate, 
both being evaluated in patients with advanced cancer. Another oral 
presentation will highlight LY2780301, an oral P70S6K/AKT inhibitor, a 
first-in-human Phase I study of patients with refractory solid tumors. 
 
Late-Stage Ramucirumab Updates 
 
Lilly will also present several trials-in-progress posters representing a 
portion of the broad Phase III clinical development program for ramucirumab, a 
fully human IgG1 monoclonal antibody receptor antagonist designed to bind to 
the extracellular domain of vascular endothelial growth factor receptor-2 
(VEGFR-2). Trial updates for ramucirumab will focus on its ongoing Phase III 
trials in metastatic colorectal cancer, metastatic gastric adenocarcinoma and 
hepatocellular cancer, as well as results of a Phase II study in persistent or 
recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. 
 
Ramucirumab represents one of the largest clinical programs currently underway 
at Lilly. Six global Phase III trials - one each in breast, colorectal, 
hepatocellular and lung cancer, and two in gastric cancer - are ongoing and 
patient enrollment milestones have recently been achieved in both the Phase III 
breast and gastric (monotherapy) cancer trials. 
 
"Lilly Oncology's clinical pipeline is one of the most diverse in the industry, 
including a mix of large and small molecules that target a broad range of 
cancers," said Richard Gaynor, M.D., vice president, product development and 
medical affairs for Lilly Oncology. "We believe that our broad oncology 
research and development program will lead to new therapies for a wide array of 
patients." 
 
Times and Locations of the Data Sessions: 
 
Ramucirumab (IMC-1121B) 
 
  * Abstract #5012: Poster Session: Friday, June 1, 2012, 1:00 PM - 5:00 PM 
 
  * 
      + A phase II, open-label, multicenter study of IMC-1121B (ramucirumab; 
        RAM) monotherapy in the treatment of persistent or recurrent epithelial 
        ovarian (EOC), fallopian tube (FTC), or primary peritoneal (PPC) 
        carcinoma (CP12-0711/NCT00721162). 
 
      + Author/Speaker: Richard T. Penson 
 
      + Location: E450a; Poster Board 1 
 
  * Abstract #TPS3634: Trials in Progress Poster Session: Monday, June 4, 2012, 
    8:00 AM - 12:00 PM 
 
  * 
      + A randomized, double-blind, phase (Ph) III study of the 
        irinotecan-based chemotherapy FOLFIRI plus ramucirumab (RAM) or placebo 
        (PL) in patients (pts) with metastatic colorectal carcinoma (mCRC) 
        progressive during or following first-line therapy with bevacizumab 
        (BEV), oxaliplatin (OXALI), and a fluoropyrimidine (FP) (RAISE) 
        (NCT01183780). 
 
      + Author/Speaker: Axel Grothey 
 
      + Location: S Hall A2; Poster Board 38G 
 
  * Abstract #TPS4139: Trials in Progress Poster Session: Monday, June 4, 2012, 
    8:00 AM - 12:00 PM 
 
  * 
      + A randomized, multicenter, double-blind, placebo (PBO)-controlled phase 
        III study of paclitaxel (PTX) with or without ramucirumab (IMC-1121B; 
        RAM) in patients (pts) with metastatic gastric adenocarcinoma, 
        refractory to or progressive after first-line therapy with platinum 
        (PLT) and fluoropyrimidine (FP). 
 
      + Author/Speaker: Hansjochen Wilke 
 
      + Location: S Hall A2; Poster Board 53B 
 
  * Abstract #TPS4146: Trials in Progress Poster Session: Monday, June 4, 2012, 
    8:00 AM - 12:00 PM 
 
  * 
      + A multicenter, randomized, double-blind, phase III study of ramucirumab 
        (IMC-1121B; RAM) and best supportive care (BSC) versus placebo (PBO) 
        and BSC as second-line treatment in patients (pts) with hepatocellular 
        carcinoma (HCC) following first-line therapy with sorafenib (SOR). 
 
      + Author/Speaker: Andrew X. Zhu 
 
      + Location: S Hall A2; Poster Board 54A 
 
NOTCH inhibitor (LY900009) 
 
  * Abstract #3008: Oral Abstract Session: Sunday, June 3, 2012, 12:15 PM - 12: 
    30 PM 
 
  * A first-in-human phase I study of the oral Notch inhibitor LY900009 in 
    patients with advanced cancer 
 
  * Author/Speaker: Shubham Pant 
 
  * Location: E Arie Crown Theater 
 
p38 MAPK inhibitor (LY2228820 dimesylate) 
 
  * Abstract # 3001: Oral Abstract Session: Sunday, June 3, 2012, 10:00 AM - 
    10:15 AM 
 
  * A first-in-human phase I study of the oral p38 MAPK inhibitor LY2228820 
    dimesylate in patients with advanced cancer. 
 
  * Author/Speaker: Matthew P. Goetz 
 
  * Location: E Arie Crown Theater 
 
P70S6K/AKT inhibitor (LY2780301) 
 
  * Abstract # 3005: Oral Abstract Session: Sunday, June 3, 2012, 11:15 AM - 
    11:30 AM 
 
  * 
      + First-in-human phase I study of LY2780301, an oral P70S6K/AKT 
        inhibitor, in patients with refractory solid tumors. 
 
      + Author/Speaker: Emiliano Calvo 
 
      + Location: E Arie Crown Theater 
 
P-LLY 
 
                                     # # # 
 
This press release contains forward-looking statements about the potential of 
ramucirumab, LY900009, LY2228820 dimesylateand LY2780301and reflects Lilly's 
current beliefs. However, as with any pharmaceutical product, there are 
substantial risks and uncertainties in the process of development and 
commercialization. There is no guarantee that the productswill becommercially 
successful. For further discussion of these and other risks and uncertainties, 
see Lilly's filings with the United States Securities and Exchange Commission. 
Lilly undertakes no duty to update forward-looking statements. 
 
 
 
Eli Lilly and Company 
 
Lilly Corporate Center 
 
Indianapolis, Indiana 46285 
 
U.S.A. 
 
 
 
                                     - 1 - 
 
 
 
 
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