ASH Clinical News ACN_5.1_Digital - Page 9

Calendar Highlights of ASH® in North America Highlights of ASH® in Asia - Pacific January 11 – 12, 2019 San Francisco, CA Washington, DC February 23 – 24, 2019 Bangkok, Thailand Highlights of ASH® in the Mediterranean January 18 – 19, 2019 Chicago, IL Seattle, WA March 15 – 16, 2019 Athens, Greece Highlights of ASH® in Latin America January 25 – 26, 2019 Dallas, TX New York, NY April 5 – 6, 2019 Lima, Peru New York, NY 63rd Annual Meeting of the Society of Thrombosis and Haemostasis Research February 27 – March 2, 2019 Berlin, Germany The 63rd congress will bridge preclinical and clinical research and patient care in the field of hemostasis and thrombosis, with the theme of “science meets clinical practice.” National Comprehensive Cancer Network 24th Annual Conference March 21 – 23, 2019 Orlando, FL With the theme of “Improving the Quality, Effectiveness, and Efficiency of Cancer Care,” the annual conference brings together oncology professionals to discuss the data upon which the NCCN Guidelines® are based. 2019 American Association for Cancer Research Annual Meeting March 29 – April 3, 2019 Atlanta, GA The annual meeting will explore the topics of integra- tive cancer science, global impact, and individualized patient care by bringing together researchers and clinicians from international institutions. For patients with previously treated CLL/SLL or B-cell NHL, LOXO ONCOLOGY IS RESEARCHING A NEW STRATEGY TO ADDRESS RESISTANCE AND INTOLERANCE TO COVALENT BTK INHIBITORS * Investigation into selective non-covalent BTK inhibition may expand possibilities for patients previously treated with a covalent BTK inhibitor LOXO-305 is an investigational, selective non-covalent BTK inhibitor currently in clinical development, with preclinical potency against both wild-type and cysteine-481–mutated BTK (C481S) and improved selectivity compared with other BTK inhibitors. 1 Oncology Nursing Society Annual Congress STUDY DESIGN 2nd AMP Global 2019 Congress on Molecular Pathology A phase 1/2, open-label, first-in-human study designed to evaluate LOXO-305 in patients with previously treated CLL/SLL, WM/MCL/MZL, FL, DLBCL, or other B-cell NHL. 4th International Symposium on Immunotherapy May 24 – 25, 2019 London, UK The Institute for Cancer Vaccines and Immunother- apy’s symposium will feature discussions about the impact of immunotherapies like checkpoint inhibi- tors and chimeric antigen receptor T-cell therapies in a variety of tumor types. 2019 American Society of Clinical Oncology Annual Meeting May 31 – June 4, 2019 Chicago, IL The American Society of Clinical Oncology brings together 32,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field. ASHClinicalNews.org Primary Outcome Measures: Phase 1: MTD/RP2D Phase 2: ORR as assessed by an Independent Review Committee Secondary Outcome Measures: Phase 2: Phase 1: • ORR as assessed by the Investigator • Safety • Best overall response • PK • Duration of response • ORR • Progression-free survival • Overall survival BTK=Bruton’s tyrosine kinase; BTKi=Bruton’s tyrosine kinase inhibitor; CLL=chronic lymphocytic leukemia; DLBCL=diffuse large B-cell lymphoma; FL=follicular lymphoma; MCL=mantle cell lymphoma; MTD=maximum tolerated dose; MZL=marginal zone lymphoma; NHL=non-Hodgkin’s lymphoma; ORR=overall response rate; PK=pharmacokinetics; RP2D=recommended phase 2 dose; R/R=relapsed/refractory; SLL=small lymphocytic leukemia; WM=Waldenström macroglobulinemia. Histologically confirmed CLL/SLL and B-cell NHL NCT03740529: A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or B-cell NHL Titration to therapeutic dose based on PK Identification of MTD/RP2D April 11 – 14, 2019 Anaheim, CA The 44th Annual Congress features the latest in research, clinical practice, advanced practice, and lead- ership, presented by oncology nursing professionals. May 16 – 18, 2019 Hong Kong, China The Association for Molecular Pathology’s second congress brings together a multidisciplinary network of molecular and diagnostics professionals to discuss its applications in health care. > NOW ENROLLING Histologically confirmed CLL/SLL and B-cell NHL R/R disease, +/- prior BTKi † , CLL/SLL, WM/MCL/MZL, FL, DLBCL, or other B-cell NHL: wild-type and C481-mutant, or other patients with clinical rationale For full eligibility requirements, please visit ClinicalTrials.gov * eg, Imbruvica® (ibrutinib) and Calquence® (acalabrutinib). † Prior treatment with any number of approved or investigational covalent or non-covalent BTK inhibitors is allowed. Reference: 1. Data on file. BTK001. 2018; Loxo Oncology, Inc. For more information about enrolling a patient or to participate as a trial site, visit LoxoBTKtrials.com or call 1-855-LOXO-305. Copyright © Loxo Oncology, Inc, 2018, All Rights Reserved. LMA-US-BTK-122018-00001 Imbruvica ® is a registered trademark of Pharmacyclics LLC and Janssen Biotech, Inc. Calquence ® is a registered trademark of AstraZeneca.