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.