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Patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) usually do not respond well
with standard therapy.
Loncastuximab tesirine（Loncastuximab tesirine-lpyl； Lonca) is a novel antibody drug conjugate (ADC) consisting of pyrrolobenzobenzodiazepine (PBD) dimer cytoxin conjugated with an anti-CD19 monoclonal antibody for patients with R/R DLBCL after prior treatment with ≥
2-line systems.
Whether as first-line or follow-up therapy, rituximab (R) is part of standard immunotherapy for
DLBCL.
There is preclinical evidence that the addition of rituximab to targeted CD19 ADC therapy may prolong tumor control time
.
Based on this, the investigators conducted the LOTIS-5 trial to evaluate the efficacy of standard immunotherapy of Lonca+R (Lonca-R) and R+ gemcitabine + oxaliplatin (R-GemOx) in patients with R/R DLBC, and at this year's annual meeting of the American Society of Hematology-Oncology (SOHO), the investigators announced the safety and preliminary efficacy results
of Lonca-R.
The study was a phase III, randomized, open-label, two-part, two-arm, multicenter study
.
Part 1 is a non-randomized safety lead-in period in which 20 patients are enrolled to determine the safety of
Lonca-R.
In Part 2, approximately 330 patients will be randomized to receive either Lonca-R or R-GemOx in a 1:1 ratio
.
The key inclusion criteria were: (1) age≥ 18 years; (2) Patients diagnosed with DLBCL (including DLBCL converted from indolent lymphoma) or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; (3) Have received ≥ first-line systemic therapy in the past; (4) Do not meet the conditions for hematopoietic stem cell transplantation; (5) Diseases
that can be evaluated according to Lugano 2014 criteria.
The study protocol is detailed in Figure 1
.
Figure 1
The primary endpoint was progression-free survival (PFS).
Secondary endpoints were overall survival (OS), overall response rate (ORR), safety, duration of response (DOR), pharmacokinetics, and change in
patient-reported outcomes.
The median age of the 20 patients in the safety transition period was 74.
5 years (range 35-93 years), and the median number of previous treatments was 1 (range 1-6).
The baseline characteristics of the patient are shown
in Table 1.
Table 1
As of 28 February 2022, the median number of doses was 5 (range: 1-8) and the median follow-up was 5.
83 months (range: 1.
9-10.
3).
Nineteen (95%) patients developed ≥ 1 adverse event (TEAE) during treatment, and 10 (50%) patients developed grade 3 TEAE
≥.
The most common of all grades of TEAE were rash (5 [25%]), fatigue (4 [20%]), and elevated γ-glutamyltransferase (4 [20%]).
The most common grade 3 TEAE ≥ were elevated γ-glutamyltransferase (3 [15%]), elevated alanine aminotransferase (2 [10%]), and neutropenia (2 [10%]).
The patient's ORR was 15/20 (75%)
.
A total of 8/20 (40%) and 7/20 (35%) achieved a complete and partial response
, respectively.
The efficacy and safety are shown
in Table 2.
Table 2
Lonca-R showed no new safety signals in patients with R/R DLBCL in the safety lead-in phase and had good antitumor activity
.
Reference sources
Kingsley E,et al.
Initial Safety Run-In Results of the Phase 3 LOTIS-5 Trial: Novel Combination of Loncastuximab Tesirine With Rituximab (Lonca-R) Versus Immunochemotherapy in Patients With R/ R DLBCL.
2022 SOHO.
ABCL-320.
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