ABCL-272 A phase 2, open-label study of loncastuximab tesirine in combination with rituximab (Lonca-R) in previously untreated unfit/frail patients with diffuse large B-cell lymphoma (LOTIS-9)
Westin, J. Burke, J. M. Chapman, A. E. Kilavuz, T. Xu, C. Shmuely, Y. Radford, John A
Westin, J.
Burke, J. M.
Chapman, A. E.
Kilavuz, T.
Xu, C.
Shmuely, Y.
Radford, John A
Citations
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Abstract
Background: Rituximab in combination with chemotherapy (R
[rituximab]-CHOP [cyclophosphamide, doxorubicin, vincristine,
and prednisone]) is standard fi rst-line therapy for patients with
diffuse large B-cell lymphoma (DLBCL). With an aging population,
unfi t or frail patients who may not tolerate R-CHOP represent an
increasing unmet need. Aim: To determine the safety and effi cacy
of the approved loncastuximab tesirine (loncastuximab tesirine-lpyp;
Lonca), an antibody-drug conjugate comprising a humanized anti CD19 monoclonal antibody conjugated to a pyrrolobenzodiazepine
dimer toxin, in combination with rituximab (Lonca-R) in previously
untreated unfi t/frail patients (LOTIS-9; NCT05144009). Methods:
This is a phase 2, open-label, response-adapted study of Lonca-R in
previously untreated unfi t (Cohort A) or frail (Cohort B) patients
with DLBCL. The simplifi ed geriatric assessment (sGA), which
identifi es three categories of fi tness (fi t, unfi t, and frail) based on
age, activities of daily living (ADL), and instrumental activities of
daily living (IADL), and the Cumulative Illness Rating Scale for
Geriatrics (CIRS-G) will be utilized to differentiate the cohorts.
Key inclusion criteria include diagnosis of DLBCL (including
DLBCL transformed from indolent lymphoma), high-grade B-cell
lymphoma, or grade 3b follicular lymphoma; Eastern Cooperative
Oncology Group performance status of 0–2; and measurable disease
(2014 Lugano Classifi cation). Each cohort will enroll 40 patients,
with fi tness (Cohort A) and frailty (Cohort B) assessed using the
sGA. Primary objectives: effi cacy (Cohorts A and B) and tolerability
(Cohort B) of Lonca-R. Primary endpoints: complete response
(CR) rate (both Cohorts) and tolerability (Cohort B) following
completion of 4 therapy cycles. Lonca-R treatment consists of R
intravenously [IV] 375 mg/m2
on day 1/cycles 1–4, (subcutaneously
allowed starting at C2), Lonca 150 µg/kg IV on day 2/cycle 1 and
day 1/cycle 2, and 75 µg/kg IV on day 1/cycles 3 and 4. Patients who
achieve CR or partial response (PR) after three cycles will receive 1
or 3 additional cycles of Lonca-R, respectively. Cohort B patients who achieve stable disease may continue to receive 3 additional
cycles. All patients will be followed for up to 5 years. Results: The
study opened for recruitment in April 2022. This abstract was
accepted for publication only at the 2022 EHA Congress. Funding:
ADC Therapeutics SA; medical writing: CiTRUS Health Group.
Description
Date
2022
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Westin J, Burke JM, Chapman AE, Kilavuz T, Xu C, Shmuely Y, et al. ABCL-272 A Phase 2, Open-Label Study of Loncastuximab Tesirine in Combination With Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Patients With Diffuse Large B-Cell Lymphoma (LOTIS-9). Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S368. PubMed PMID: 36164069. Epub 2022/09/28. eng.