1. CHARACTERIZATION AND MANAGEMENT OF CUTANEOUS REACTIONS IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA TREATED WITH LONCASTUXIMAB TESIRINE IN THE LOTIS-2 TRIAL.
- Author
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Pruett, Julie, Zellner, Katie, Kahl, Brad, Ungar, David, Luqiang Wang, and Hamadani, Mehdi
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THERAPEUTIC use of monoclonal antibodies , *B cell lymphoma , *CUTANEOUS manifestations of general diseases , *CONFERENCES & conventions , *DRUG side effects - Abstract
Loncastuximab tesirine (loncastuximab tesirine-lypl; Lonca), an FDA-approved antibody drug conjugate comprising a CD19-targeted antibody conjugated to a pyrrolobenzodiazepine (PBD) dimer cytotoxin, is indicated in relapsed or refractory diffuse large B-cell lymphoma after ≥2 prior systemic therapies. Several adverse events (AEs), including cutaneous reactions, are likely related to the PBD cytotoxin. Knowledge of potential adverse cutaneous reactions that may impact a patient's quality of life is necessary for healthcare professionals to effectively counsel and manage patients on treatment. The objective of this project was to describe the onset and management of cutaneous reactions, including photosensitivity and non-photosensitivity reactions, in the pivotal LOTIS-2 trial (NCT03589469). The methodology for LOTIS-2 has been published (Caimi, et al 2021). For this analysis (data cutoff: 01 March 2021), the number (%) of photosensitivity and non-photosensitivity cutaneous reactions, time to treatment-emergent AEs (TEAEs), action taken, and duration of cutaneous reactions were included. Non-photosensitivity reactions include rash and pruritus. To determine duration of cutaneous reactions, missing AE end dates were imputed using the date of new anticancer therapy, end of study or data cutoff date. Of the 145 patients who received Lonca in LOTIS-2, 15 (10.3%) had photosensitivity reactions (3 [2.1%] patients experienced Grade ≥3) and 44 (30.3%) had non-photosensitivity reactions (3 [2.1%] patients experienced Grade ≥3). The median (min, max) time to onset was 37.0 (13, 150) days for any-grade and 32.0 (13, 35) days for Grade ≥3 photosensitivity reactions; and 30.5 (1, 104) days for any-grade and 56.0 (8, 89) days for Grade ≥3 non-photosensitivity reactions. Dose modifications to manage Grade ≥3 cutaneous reactions (dose delays, modifications, or withdrawals) occurred in <5% of patients. The median (min, max) duration of any-grade photosensitivity reactions was 119.0 (35, 357) days and 38 (12,88) days for Grade ≥3 events. The median (min, max) duration of any-grade non-photosensitivity reactions was 85.5 (1, 689) days and 7.0 (2,10) days for Grade ≥3 events. In LOTIS-2, the incidence of Grade ≥3 cutaneous reactions was low, typically occurred within 60 days of starting treatment, and were managed by dose delay. Patients should be advised to minimize and protect skin from sun exposure. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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