On May 18, 2016 Eli Lilly reported that several studies will underscore the strength of Eli Lilly and Company’s (NYSE: LLY) diverse clinical cancer pipeline and portfolio during the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, June 3 – 7, 2016 (Press release, Eli Lilly, MAY 18, 2016, View Source [SID:1234512520]). 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.
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Other data to be presented at ASCO (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) 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)