Lilly Presenting Data on Key Therapies

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Indianapolis-based Eli Lilly and Co. (NYSE: LLY) is at a major medical conference presenting early-stage data on a number of potential treatments in its cancer pipeline. The company is detailing research on therapies to treat lung, breast, colorectal, gastric and liver diseases during the American Association for Cancer Research (AACR) Annual Meeting in California. April 6, 2014

News Release

INDIANAPOLIS, Ind - Eli Lilly and Company (NYSE: LLY) will present early-stage data from several targeted cancer therapies - including bemaciclib "beh meh sye' klib" (LY2835219), its oral, cell-cycle inhibitor of CDK4/6 - that make up its diverse clinical oncology pipeline during the American Association for Cancer Research (AACR) Annual Meeting 2014 held in San Diego, Calif. from April 5 - 9.

"Harnessing Breakthroughs - Targeting Cures" is the theme of this year's AACR meeting and one that is mirrored throughout Lilly's early-stage oncology research. Lilly's oncology pipeline is among the most robust across the pharmaceutical industry and includes a broad range of large and small molecules being investigated to treat a wide range of cancers including lung, breast, colorectal, gastric, liver and hematologic malignancies. Lilly research presented at AACR will represent early findings from several of those early-stage clinical agents.

Data from bemaciclib, Lilly's CDK4/6 inhibitor LY2835219 as a potential treatment for metastatic breast cancer, has been accepted as a late-breaking presentation that will be included at AACR's Clinical Trials Symposium and will be featured in an official AACR-sponsored press conference.

"The CDK4/6 pathway is one of the most commonly implicated pathways in all cancers, making it an important area for research," said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology. "The single-agent activity we've observed for bemaciclib is encouraging in this setting and we believe the data support the need for further development in metastatic breast cancer."

Lilly's B-Raf inhibitor LY3009120 will be highlighted at AACR's New Drugs on the Horizon special session where first data disclosures of promising, new anti-cancer compounds that target key pathways will occur. There will also be an oral presentation on Lilly's c-MET kinase inhibitor, LY2801653.

"As we gain a better understanding about the distinct tumor biologies and other individual characteristics that make one tumor different than another, we are able to apply this knowledge to our development of potential new cancer treatments, such as those we are presenting at AACR," said Dr. Gaynor. "Each step we take during early-stage research - both in the lab and on clinical trials - leads us toward the same overall goal: to increase the number of treatment options available to patients."

Select Lilly early-stage pipeline studies, along with the times and locations of their data sessions, are highlighted below.

bemaciclib (LY2835219)

Abstract #CT232: Clinical Trials Symposium: Monday, April 7, 2014 1:30 pm - 1:50 pm

Clinical activity of LY2835219, a novel cell cycle inhibitor selective for CDK4 and CDK6, in patients with metastatic breast cancer

Author/Speaker: Amita Patnaik, M.D., FRCP(C)

Location: Room 25

Note: Abstract #CT232 to be presented at AACR press conference on April 6 at 7:30 am

B-Raf Inhibitor (LY3009120)

Abstract #7135: New Drugs on the Horizon Special Session: Sunday, April 6, 2014 3:45 pm to 4:10 pm

Identification of LY3009120 as a pan inhibitor of Raf isoforms and dimer with activity against BRaf or Ras mutant tumor cells and minimal paradoxical activation

Author/Speaker: Sheng-Bin Peng, Ph.D.

Location: Room 29

c-MET Inhibitor (LY2801653)

Abstract #CT237: Clinical Trials Minisymposium: Monday, April 7, 2014 3:20 pm - 3:35 pm

Interim results of a first-in-human Phase I study of the oral MET kinase inhibitor, LY2801653, in patients with advanced cancer

Author/Speaker: Jimmy Hwang, M.D.

Location: Room 29

Abstract #4403: Poster Presentation: Tuesday April 8, 2014 1:00 pm to 5:00 pm

Preclinical evaluation of LY2801653, an orally bioavailable small molecule oncokinase inhibitor, in cholangiocarcinoma models

Author/Speaker: S. Betty Yan, Ph.D.

Location: Hall A-E, Section 24

FGFR Inhibitor (LY2874455)

Abstract #CT215: Poster Presentation: Monday, April 7, 2014 8:00 am to 12:00 pm

A Phase 1 Study of LY2874455, a Fibroblast Growth Factor Receptor Inhibitor, in Patients with Advanced Cancer

Author/Speaker: Dr. Jeanne Tie

Location: Hall A-E, Section 38

Source: Eli Lilly and Co.