ABCL-316 Health-related quality of life and tolerability in patients with/without skin toxicity during loncastuximab tesirine treatment in a phase 2 clinical trial (LOTIS-2)

Abstract

Context: Skin toxicity was commonly reported among patients treated with loncastuximab tesirine (loncastuximab tesirine-lpyl; Lonca). Most skin toxicities (~90%) were grade 1 or 2, but their impact on health-related quality of life (HRQOL) was unknown. Objective: This post hoc analysis assesses whether skin toxicity is associated with HRQOL and patient tolerability to Lonca. Design: The LOTIS-2 study (NCT03589469) is a single-arm, open label, phase 2 study of 145 adult patients with relapsed/refractory diffuse large B-cell lymphoma after 2 prior treatments. Patients received Lonca as an intravenous infusion on day 1 of each 3-week treatment cycle for up to 1 year. EQ-5D and FACT-Lym scores were collected. Mean changes from baseline were summarized by visit and with/without skin toxicity. The least-squares means of the differences were estimated using the analysis of covariance models to adjust for age, sex, race, baseline score, and tumor response status. Treatment tolerability was measured using FACT-Lym item GP5 (“I am bothered by side effects of treatment”). Results: Patients with an HRQOL baseline score and a postbaseline score (n=130) were included in the analysis (median age, 66 years; 59% male; and 88% White). With a median of 4 cycles of treatment (range, 1–26), 41% of patients experienced skin toxicity during treatment, >80% due to non-photosensitivity cutaneous reactions. Among all 9 evaluated scores (EQ-5D visual analog scale, FACT-Lym subscale, and composite scores) for visits up to cycle 9 (n20), there were no signifi cant differences (P>0.05) between patients with and without skin toxicity except for the FACT-Lym total at cycle 9 (worse in patients with skin toxicity). A majority of patients (60%) were “not at all” or “a little bit” bothered in both groups at each cycle, although a higher percentage of patients with skin toxicity reported “a little bit” than those without skin toxicity after 2 cycles. Conclusions: Patients with skin toxicity while receiving Lonca did not experience different HRQOL compared with patients without skin toxicity in most visits. Lonca was tolerated well even among patients with skin toxicity. (Sponsored by ADC Therapeutics)..