Lilly Highlights ASCO Data Underscores Co.'s Diverse Oncology Pipeline, Portfolio

Several studies will underscore the strength of Eli Lilly and Company's

diverse clinical cancer pipeline and portfolio during the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 3 – 7, 2016. Presentations include new data on abemaciclib, a CDK 4 and 6 inhibitor, as well as: ramucirumab, a VEGF Receptor 2 antagonist; galunisertib, a TGFβ small-molecule kinase inhibitor; and emibetuzumab, a MET antibody. Other data to be presented at ASCO highlight Lilly's ongoing immuno-oncology clinical collaborations with Merck (known as MSD outside the U.S. and Canada) in two trials that are evaluating ramucirumab and pemetrexed-plus-carboplatin, respectively, in combination with Merck's pembrolizumab. These presentations reflect Lilly's multi-faceted strategy in developing cancer treatments – a balanced approach based on three scientific pillars of tumor cell growth and progression: cell signaling, tumor microenvironment and immuno-oncology. Lilly's data at this year's ASCO meeting highlight some of the recent progress it has made toward this strategy and touch on all three of these scientific pillars. "The reality is that cancer is more than 200 diseases and the treatment of cancer needs to be aggressively approached from many angles," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "Our oncology R&D strategy is to produce a diverse portfolio of novel agents that attack tumor cell growth and progression in multiple ways to improve patient outcomes." Dr. Gaynor continued, "We are encouraged by our data at ASCO and the progress of our pipeline toward achieving our overall goals. We've had notable clinical advancements with abemaciclib and olaratumab, both of which have been designated as breakthrough therapies by the FDA. These build on necitumumab and ramucirumab, which we are continuing to investigate in additional disease settings and combinations. Additionally, our immuno-oncology initiatives are increasingly producing results through collaborations and our own internal research efforts." Select studies, along with the times and locations of their data sessions, are highlighted below. Abemaciclib Abstract #510: Oral Abstract Session: Friday, June 3, 2016; 4:42 – 4:54 pm CDT MONARCH 1: Results from a phase 2 study of abemaciclib, a CDK4 and CDK6 inhibitor, as monotherapy, in patients with HR+/HER2- breast cancer, after chemotherapy for advanced disease Author/Speaker: Maura N. Dickler, M.D., Memorial Sloan Kettering Cancer Center Location: Hall D1 Abstract #TPS9101: Lung Cancer—Non-Small Cell Metastatic Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT A randomized phase 2 study of abemaciclib versus docetaxel in patients with stage IV squamous cell lung cancer (SqCLC) previously treated with platinum-based chemotherapy Author/Speaker: Giorgio V. Scagliotti, M.D., Ph.D., University of Torino Location: Hall A (Poster Board #423a) Immuno-Oncology Collaborations with ramucirumab or pemetrexed Abstract #3056: Developmental Therapeutics—Immunotherapy Poster Session: Sunday, June 5, 2016; 8:00 – 11:30 am CDT A phase 1 study of ramucirumab (R) plus pembrolizumab (P) in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or urothelial carcinoma (UC): Phase 1a results Author/Speaker: Roy S. Herbst, M.D., Ph.D., Yale University School of Medicine, Yale Cancer Center Location: Hall A (Poster Board #378) Abstract #9016: Lung Cancer—Non-Small Cell Metastatic Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT Pembrolizumab (pembro) plus chemotherapy as front-line therapy for advanced NSCLC: KEYNOTE-021 cohorts A-C Author/Speaker: Shirish M. Gadgeel, M.D., Karmanos Cancer Institute Location: Hall A (Poster Board #339) Poster Discussion Session: Saturday, June 4, 2016; 3:00 – 4:15 pm CDT Room E354b Ramucirumab Abstract #TPS4145: Gastrointestinal (Noncolorectal) Cancer Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT A randomized, double-blind, placebo-controlled Phase III study of ramucirumab versus placebo as second-line treatment in patients with hepatocellular carcinoma and elevated baseline alpha-fetoprotein following first-line sorafenib (REACH-2) Author/Speaker: Andrew X. Zhu, M.D., Ph.D., Massachusetts General Hospital Cancer Center Location: Hall A (Poster Board #130a) Abstract #9079: Lung Cancer—Non-Small Cell Metastatic Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT Exploratory subgroup analysis of patients (Pts) refractory to first-line (1L) chemotherapy from REVEL, a randomized phase III study of docetaxel (DOC) with ramucirumab (RAM) or placebo (PBO) for second-line (2L) treatment of stage IV non-small-cell lung cancer (NSCLC) Author/Speaker: Martin Reck, M.D., Ph.D., Lungen Clinic Grosshansdorf, Airway Research Center North Location: Hall A (Poster Board #402) Galunisertib Abstract #4070: Gastrointestinal (Noncolorectal) Cancer Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT A phase 2 study of galunisertib, a novel transforming growth factor-beta (TGF-β) receptor I kinase inhibitor, in patients with advanced hepatocellular carcinoma (HCC) and low serum alpha fetoprotein (AFP) Author/Speaker: Sandrine J. Faivre, M.D., Ph.D., Service d'Oncologie Médicale Location: Hall A (Poster Board #62) Abstract #4019: Gastrointestinal (Noncolorectal) Cancer Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT A phase II, double-blind study of galunisertib+gemcitabine (GG) vs gemcitabine+placebo (GP) in patients (pts) with unresectable pancreatic cancer (PC) Author/Speaker: Davide Melisi, M.D., University of Verona Location: Hall A (Poster Board #11) Poster Discussion Session: Saturday, June 4, 2016; 3:00 – 4:15 pm CDT at Hall D1 Emibetuzumab Abstract #9070: Lung Cancer—Non-Small Cell Metastatic Poster Session: Saturday, June 4, 2016; 8:00 – 11:30 am CDT A randomized, open-label, phase 2 study of emibetuzumab plus erlotinib (LY+E) and emibetuzumab monotherapy (LY) in patients with acquired resistance to erlotinib and MET diagnostic positive (MET Dx+) metastatic NSCLC Author/Speaker: D. Ross Camidge, M.D., Ph.D., University of Colorado Location: Hall A (Poster Board #393)