Phase 2 N=87 Treatment

A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)

Leukemia, Lymphoid · Lymphoma, Non-Hodgkin · Lymphoma, Mantle-Cell · Lymphoma, Large B-Cell, Diffuse · Lymphoma, B-Cell

Bottom Line

View on ClinicalTrials.gov: NCT04849416 ↗

Enrolled (actual)

Serious AEs

37.9%

Results posted

Jul 2024

Primary outcome: Primary: Primary Analysis Set (PAS): Overall Response Rate (ORR) Assessed by Independent Review Committee — 71.4 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LOXO-305 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Analysis Set (PAS): Overall Response Rate (ORR) Assessed by Independent Review Committee	71.4	—
SECONDARY PAS ORR: ORR Assessed by Investigator	64.3	—
SECONDARY PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)	14.3; 57.1; 7.1; 14.3; 7.1; 14.3	—
SECONDARY PAS: Duration of Response (DOR)	NA; 11.50	—
SECONDARY PAS: Progression Free Survival (PFS)	9.43; 6.80	—
SECONDARY PAS: Overall Survival (OS)	15.47	—
SECONDARY Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration(AUC[0-tlast] of LOXO-305	62700; 123000; 137000; 46600	—
SECONDARY PK: Maximum Concentration (Cmax) of LOXO-305	4800; 8380; 9080; 7890	—
SECONDARY PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	2.5; 0.8; -2.9; -2.0; -1.0; -7.8	—

Summary

A study of the safety, side effects, and effectiveness of LOXO-305 in Chinese adults with lymphoma or chronic leukemia who have already had standard of care treatment. Participation could last up to four years.

Eligibility Criteria

Inclusion Criteria

Participants with histologically confirmed B-cell malignancy including:
Mantle cell lymphoma (MCL) treated with a prior Bruton's tyrosine kinase (BTK) inhibitor containing regimen;
CLL/SLL treated with a prior BTK inhibitor containing regimen;
Other types of B-cell NHL
All participants must have disease requiring treatment, for CLL/SLL participants, at least 1 indication for treatment consistent with IWCLL 2018 criteria is required
Eastern Cooperative Oncology Group 0-2
Adequate hematologic status, coagulation, hepatic and renal function

Exclusion Criteria

Lack of adequate wash-out period for investigational agent or anticancer therapy, major surgery, and radiotherapy prior to the first dose of study treatment
Participants requiring therapeutic anticoagulation with warfarin
Known central nervous system (CNS) involvement by systemic lymphoma. Primary CNS lymphoma is excluded
Significant cardiovascular disease
Prolongation of the QT interval
Test positive for human immunodeficiency virus (HIV)
Current treatment with certain strong cytochrome P450 3A4 (CYP450 3A4) inhibitors or inducers and/or strong p-glycoprotein (P-gp) inhibitors
Pregnancy or lactation
Active second malignancy
Prior treatment with LOXO-305
Known hypersensitivity to any component or excipient of LOXO-305

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04849416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.