ASH Clinical News ACN_5.5_full_issue_web | Page 7
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 *
> NOW
ENROLLING
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
STUDY DESIGN
NCT03740529:
A Phase 1/2 Study of Oral LOXO-305 in Patients
With Previously Treated CLL/SLL or B-cell NHL
Secondary Outcome Measures:
Phase 1:
Phase 2:
• Safety
• ORR as assessed by the Investigator
• Best overall response
• PK
• ORR
• Duration of response
• 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.
* 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.
Primary Outcome Measures:
Phase 1:
MTD/RP2D
Phase 2:
ORR as assessed by an Independent Review Committee
Titration to therapeutic dose based on PK
Identification of MTD/RP2D
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.
Histologically confirmed CLL/SLL and B-cell NHL
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
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.