Table of Contents
- Clinical trial overview
- Main studies and patient groups
- What the trials measure
- Trial phases and what they mean
- Who may take part
- Key points from the trial data
Clinical trial overview
These studies are testing Loncastuximab Tesirine in people with different kinds of lymphoma, especially cases that are relapsed or refractory.[1][2][3][4][5][6]
The trial data focus on whether the treatment helps the cancer respond, how long the response lasts, and how it performs in specific patient groups such as adults, children, adolescents, and patients after CAR T-cell therapy.[1][2][3][5][6]
Main studies and patient groups
The largest study listed is LOTIS 5, a Phase 3 randomized study in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It compares Loncastuximab Tesirine combined with rituximab against standard immunochemotherapy.[1]
Another Phase 2 study looks at Loncastuximab Tesirine with epcoritamab in relapsed or refractory DLBCL, high-grade B-cell lymphoma (HGBL), and follicular lymphoma grade 3B. One version of this study was withdrawn, while another is authorised.[2][4]
A Phase 2 study in mantle cell lymphoma is testing Loncastuximab Tesirine after a short course of immunochemotherapy in patients who were treated with a BTKi or could not tolerate a BTKi. BTKi means Bruton Tyrosine Kinase inhibitor, a type of treatment used in some blood cancers.[3]
The Glo-BNHL study is a Phase 4 trial in pediatric and adolescent patients with relapsed and refractory mature B-cell non-Hodgkin lymphoma. It includes Loncastuximab Tesirine as one of several treatment options being studied in young patients.[5]
The LORELY study is a Phase 2 trial for patients with relapsed or refractory DLBCL or high-grade B-cell lymphoma whose disease progressed after CAR T-cell therapy.[6]
What the trials measure
Several trials use overall response rate (ORR) or best overall response rate (BORR) as key outcomes.[2][6] These measures show how many patients have a complete response, meaning no visible cancer on tests, or a partial response, meaning the cancer has shrunk.[2][6]
The Phase 3 LOTIS 5 study uses progression-free survival (PFS) as its main endpoint. This means the trial measures how long patients live without the disease getting worse or dying from any cause.[1]
The mantle cell lymphoma study also uses 12-month PFS, measured from enrollment and checked on an intention-to-treat basis, which means all enrolled patients are counted in the analysis as planned.[3]
In the pediatric and adolescent study, one arm measures objective response after 12 weeks, while another arm measures complete response within a maximum of three treatment cycles.[5]
Trial phases and what they mean
The trial phases in the data are Phase 2, Phase 3, and Phase 4.[1][2][3][5][6] Phase 2 studies usually look closely at whether the treatment works and continue to collect safety information. Phase 3 studies compare treatments in larger groups, and Phase 4 studies look at use in broader or special populations after earlier research.[1][2][3][5][6]
Who may take part
Participation depends on the study, but all listed trials focus on people with specific lymphoma types and treatment histories.[1][2][3][5][6]
Adults with relapsed or refractory DLBCL may be eligible for the Phase 3 LOTIS 5 study.[1]
Adults with relapsed or refractory DLBCL, HGBL, or follicular lymphoma grade 3B may be included in the Phase 2 combination study with epcoritamab.[2]
Patients with relapsed or refractory mantle cell lymphoma who were treated with, or could not tolerate, a BTKi may be included in the consolidation study.[3]
Children and adolescents with relapsed and refractory mature B-cell non-Hodgkin lymphoma are the focus of the Glo-BNHL study.[5]
Patients with DLBCL or HGBL whose disease progressed after CAR T-cell therapy may be eligible for the LORELY study.[6]
Key points from the trial data
The available trial data show that Loncastuximab Tesirine is being studied across several lymphoma settings, with the strongest focus on relapsed or refractory disease.[1][2][3][4][5][6]
The studies are measuring how many patients respond, how durable the response is, and how the treatment performs in special groups such as patients after CAR T-cell therapy and younger patients.[1][2][3][5][6]
