On October 5, 2016 Eli Lilly and Company (NYSE: LLY) reported that it will present data from several studies which further reinforce the advancement of its diverse clinical cancer portfolio during the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper)’s (ESMO) (Free ESMO Whitepaper) 2016 Congress in Copenhagen, October 7-11 (Press release, Eli Lilly, OCT 5, 2016, View Source [SID:SID1234515631]). Presentations include new data on abemaciclib, a CDK 4 and CDK 6 inhibitor, and olaratumab, a PDGFRα blocking antibody that recently received a positive CHMP opinion, as well as data on: pemetrexed, a multi-targeted antifolate; ramucirumab, a VEGF Receptor 2 antagonist; necitumumab, an EGFR blocking antibody; and prexasertib, a cell cycle checkpoint kinases 1 and 2 inhibitor. Of these presentations, four are featured in late-breaking abstracts (two on abemaciclib, and one each on pemetrexed and ramucirumab).

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The presentations on pemetrexed, ramucirumab and necitumumab include data from a few of Lilly’s immuno-oncology clinical collaborations with Merck (known as MSD outside the U.S. and Canada) in trials that are evaluating these molecules in combination with Merck’s pembrolizumab. Notably, the first results from KEYNOTE-021G – which studied pembrolizumab in combination with pemetrexed-plus-carboplatin compared to pemetrexed-plus-carboplatin alone for the first-line treatment of patients with advanced nonsquamous non-small cell lung cancer regardless of PD-L1 expression – will be featured in the Presidential Symposium on October 9.

Lilly’s data at the ESMO (Free ESMO Whitepaper) 2016 Congress highlight the ongoing progress in expanding the potential of its portfolio molecules as well as the advancement of its clinical pipeline. These presentations underscore the company’s multi-faceted strategy in developing cancer treatments – to produce a diverse portfolio of novel agents that attack tumor cell growth and progression in multiple ways to improve patient outcomes. Specifically, this is a balanced approach based on three scientific pillars of tumor cell growth and progression:

Tumor cell signaling: Therapies that target cell signaling to interrupt the communication system that enables cancer cells to coordinate their basic activities;
Tumor microenvironment: Treatments attacking the tumor microenvironment which work by reducing the flow of nutrients and mitogens that support and feed tumor cells; and
Immuno-oncology: Therapies that use the patient’s own immune system to fight cancer.
"Lilly’s three-pillar oncology R&D strategy is unique," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "While there’s no single therapy or one way to attack tumor cell growth and progression that works for all patients, as an industry we are continually learning how some approaches work better than others in certain patient populations. Lilly is aggressively approaching cancer therapy development from many angles, including the study of combination therapies across the three pillars to address tumor heterogeneity and drug resistance, through our own efforts and research collaborations. Data to be presented at this year’s ESMO (Free ESMO Whitepaper) Congress demonstrate our intent to bring forth best-in-class treatment options to help patients around the world."

Select studies, along with the times and locations of their data sessions, are highlighted below.

Abemaciclib

Abstract Title: Interim results from neoMONARCH: a neoadjuvant phase II study of abemaciclib in postmenopausal women with HR+/HER2- breast cancer (BC)
Abstract #: LBA13; Proffered Paper session: Friday, October 7, 16:00 – 17:30 CEST
Author/Speaker: Sara Hurvitz, M.D., UCLA Jonsson Comprehensive Cancer Center
Location/Room: Stockholm
Abstract Title: Exploratory biomarkers in MONARCH 1, a phase II study of abemaciclib monotherapy in hormone-receptor positive (HR+) HER2- metastatic breast cancer (MBC)
Abstract #: LBA12; Poster Discussion session: Sunday, October 9, 16:30 – 17:30 CEST
Author/Speaker: Sara M. Tolaney, M.D., MPH, Dana-Farber Cancer Institute
Location/Room: Berlin
Immuno-Oncology Collaborations with Pemetrexed, Ramucirumab and Necitumumab

Abstract Title: Randomized, phase 2 study of carboplatin and pemetrexed with or without pembrolizumab as first-line therapy for advanced NSCLC: KEYNOTE-021 cohort G
Abstract #: LBA46_PR; Presidential Symposium session: Sunday, October 9, 16:25 – 18:20 CEST
Author/Speaker: Corey Langer, M.D., University of Pennsylvania
Location/Room: Copenhagen
Abstract Title: Interim safety and clinical activity in patients with advanced NSCLC from a multi-cohort phase 1 study of ramucirumab (R) plus pembrolizumab (P)
Abstract #: LBA38; Poster Discussion session: Monday, October 10, 09:30 – 10:30 CEST
Author/Speaker: Roy S. Herbst, M.D., Ph.D., Yale Cancer Center
Location/Room: Berlin
Abstract Title: Safety of necitumumab and pembrolizumab combination therapy in patients with stage IV non-small cell lung cancer (NSCLC): A phase 1b expansion cohort study
Abstract #: 1260P; Poster Display session: Saturday, October 8, 13:00 – 14:00 CEST
Author/Speaker: Benjamin Besse, M.D., Ph.D., Institut d’Oncologie Thoracique
Location/Room: Hall E
Olaratumab

Abstract Title: Exposure-response of olaratumab for survival outcomes and safety when combined with doxorubicin in soft tissue sarcoma (STS) patients
Abstract #: 1402PD; Poster Discussion session: Monday, October 10, 11:00 – 12:00 CEST
Author/Speaker: Robin L. Jones, BSc, MB, MRCP, M.D., Fred Hutchinson Cancer Research Center
Location/Room: Brussels
Abstract Title: ANNOUNCE 2: An open-label phase 1b, and a randomized, double-blind phase 2 study of olaratumab with gemcitabine plus docetaxel in the treatment of patients with advanced soft tissue sarcoma (STS)
Abstract #: 1420TiP; Poster Display session: Monday, October 10, 13:00 – 14:00 CEST
Author/Speaker: Andrés Redondo, M.D., Hospital Universitario La Paz
Location/Room: Hall E
Prexasertib

Abstract Title: A phase II study of the cell cycle checkpoint kinases 1 and 2 inhibitor (LY2606368; Prexasertib monomesylate monohydrate) in sporadic high-grade serous ovarian cancer (HGSOC) and germline BRCA mutation-associated ovarian cancer (gBRCAm+ OvCa)*
Abstract #: 855O; Proffered Paper session: Friday, October 7, 14:00 – 15:30 CEST
Author/Speaker: Jung-min Lee, M.D., Center for Cancer Research, National Cancer Institute, National Institutes of Health
Location/Room: Oslo
Ramucirumab

Abstract Title: Ramucirumab (RAM) as a second-line treatment in patients (pts) with advanced hepatocellular carcinoma (HCC): Prognosis, efficacy, and safety by liver disease etiology
Abstract #: 617PD; Poster Discussion session: Saturday, October 8, 08:00 – 09:00 CEST
Author/Speaker: Takuji Okusaka, M.D., National Cancer Center Hospital
Location/Room: Copenhagen
Abstract Title: 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)
Abstract #: 710TiP; Poster Display session: Saturday, October 8, 13:00 – 14:00 CEST
Author/Speaker: Andrew X. Zhu, M.D., Ph.D., Massachusetts General Hospital Cancer Center
Location/Room: Hall E

*This presentation on prexasertib includes data from an investigator-initiated trial sponsored by the Center for Cancer Research, National Cancer Institute (NCI), part of the National Institutes of Health.