Updates on three of six ongoing Phase III Ramucirumab trials to be presented

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