MET Inhibitor. Merestinib, LY Drug Discovery Platform: Cancer Cell Signaling. Derived from Christensen JG, et al 1 ; Eder JP, et al.
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1 MET Inhibitor Merestinib, LY Derived from Christensen JG, et al 1 ; Eder JP, et al. 2 Drug Discovery Platform: Cancer Cell Signaling
2 A Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo Plus and Gemcitabine as First-line Treatment in Patients With Advanced or Metastatic Biliary Tract Cancer* Patients with advanced or metastatic biliary tract cancer Key Inclusion Criteria Key Exclusion Criteria Nonresectable, recurrent, or metastatic biliary tract adenocarcinoma (eg, of the gallbladder, intra- and extra-hepatic cholangiocarcinoma, or Ampulla of Vater) Previous systemic therapy for locally advanced or metastatic disease Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 History of or current hepatic encephalopathy of any grade, ascites of grade >1, or cirrhosis with Child-Pugh class B or higher Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Ongoing or recent ( 6 months) hepatorenal syndrome Adequate biliary drainage Arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization Adequate organ function Willing to provide blood and tissue samples for research purposes Uncontrolled arterial hypertension despite standard medical management History of gastrointestinal perforation and/or fistulae within 6 months prior to randomization Randomization 2:1:2:1 Arm A + ramucirumab Arm B + placebo + merestinib + placebo History of uncontrolled hereditary or acquired thrombotic disorder Mixed hepatocellular biliary tract cancer histology Please visit for more information on this clinical trial [NCT ]. * This clinical trial is being conducted globally. Primary endpoint: Progression-free survival Participants continue study treatment until disease progression or discontinuation criteria are met. 2 3
3 A Phase 1 Study of LY in Patients With Advanced Cancer* Part A: Key Inclusion Criteria Key Exclusion Criteria Part A: Cancer that is advanced and/or metastatic (solid tumors or non-hodgkin lymphoma) Symptomatic central nervous system malignancy or metastasis Part B: Colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), cholangiocarcinoma (CCA), or uveal melanoma Current acute or chronic leukemia Part C: HNSCC Part D: CCA Part E: CCA Part F: Gastric carcinoma, including gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. Participants must have adequate coagulation function as defined by international normalized ratio 1.5 and a partial thromboplastin time 5 seconds above the upper limit of normal (unless receiving anticoagulation therapy) Parts B, C, D, and E: Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Part F: Measurable and/or evaluable disease Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Parts B (except uveal melanoma), C, D, E, and F: Tumor sites that are not amenable to tissue sample collection. For participants in these portions of the study, a tumor tissue sample is mandatory, when safe and feasible Part B: Dose confirmation of Cohort B1: CRC Cohort B2: HNSCC Cohort B3: CCA Cohort B4: Uveal melanoma Part F: The participant has experienced a grade 3 bleeding event within 3 months prior to enrollment, any arterial or venothrombotic or thromboembolic events, including, but not limited to, myocardial infarction, transient ischemic attack, or cerebrovascular accident, within 6 months prior to enrollment Please visit for more information on this clinical trial [NCT ]. * This clinical trial is being conducted in the United States. Lilly defines the start of phase II as the first dose in a clinical trial for the purpose of evaluating efficacy, whether that occurs in a phase I cohort or a separate phase II trial. This asset is considered by Lilly to be in phase II, although these materials and list it as phase I based on a phase I trial. Dose escalation of merestinib Part C: in HNSCC + cetuximab Part D: in CCA + cisplatin Part E: in CCA and cisplatin Part F: in gastric cancer + ramucirumab Primary endpoint: Recommended phase 2 dose and schedule 4 5
4 6 7
5 Target Molecule Mesenchymal-epithelial transition factor (MET) is a tyrosine kinase receptor for hepatocyte growth factor (HGF). In tumor cells, MET signaling is activated either by binding HGF, its only known ligand, or, in the case of overexpression or amplification of MET, by ligandindependent activation/dimerization.3 Both ligand-dependent and ligand-independent MET activation trigger downstream signaling pathways known to be involved in tumor cell proliferation, protection from apoptosis, and metastasis. In addition, pathway activation is believed to act as a resistance mechanism to other cancer therapies.4-6 Dysregulation of the MET pathway is an important feature of many human malignancies, including lung, breast, and colorectal.1 Merestinib (LY ) is a small molecule that has been shown in vitro to be a reversible type II ATP-competitive inhibitor of MET. Preclinical testing also has shown merestinib to inhibit several other receptor tyrosine oncokinases including MST1R, FLT3, AXL, MERTK, TEK, ROS1, NTRK1/2/3, and DDR1/2 and the serine/threonine kinases MKNK1/2.7,8 Clinical Development Merestinib is being investigated in a phase I clinical trial and in a clinical trial in patients with biliary tract cancer. Lilly defines the start of phase II as the first dose in a clinical trial for the purpose of evaluating efficacy, whether that occurs in a phase I cohort or a separate phase II trial. This asset is considered by Lilly to be in phase II, although these materials and list it as phase I based on a phase I trial. References: 1. Christensen JG, et al. Cancer Lett. 2005;225(1): Eder JP, et al. Clin Cancer Res. 2009;15(7): Gherardi E, et al. Nat Rev Cancer. 2012;12(2): Engelman JA, et al. Science. 2007;316(5827): Yano S, et al. Cancer Sci. 2012;103(7): McDermott U, et al. Cancer Res. 2010;70(4): Yan SB, et al. Invest New Drugs. 2013;31(4): Konicek BW, et al. AACR Annual Meeting; April 16-20, 2016; New Orleans, LA. Abstract ON /2016 PRINTED IN USA Lilly USA, LLC All rights reserved.
Drug Discovery Platform: Cancer Cell Signaling. MET Inhibitor. Merestinib, LY Christensen JG, et al1; Eder JP, et al 2
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