Primary Results of the Health-Related Quality of Life (HRQoL) and Tolerability Assessments from the Phase I/II NP30179 Study of Glofitamab Monotherapy in Patients with Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL)

• Published in: Blood 2024-11, Vol.144 (Supplement 1), p.1726-1726
• Main Authors: Bachy, Emmanuel, Trask, Peter, Morschhauser, Franck, Corradini, Paolo, Wu, Shang-Ju, Bartlett, Nancy L., Mulvihill, Estefania, Bene Tchaleu, Fabiola, Lundberg, Linda, Carlo-Stella, Carmelo
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2024-194337

Background: Meaningful improvements in, or maintenance of, pre-treatment HRQoL are crucial for patients (pts) with R/R LBCL; therefore, it is important that treatments (txs) do not introduce toxicities that negatively impact pts' quality of life (QoL). Glofitamab (Glofit) is a CD20xCD3 bispecific antibody that engages and redirects T cells to eliminate B cells. Glofit monotherapy is approved in pts with R/R LBCL after ≥2 prior lines of therapy (LoT), based on data from a Phase I/II study (NP30179; NCT03075696). Results showed that fixed-duration Glofit was well tolerated and induced high complete response rates and durable responses with a manageable safety profile (Dickinson NEJM 2022; Hutchings ASH 2023). Here, we present patient-reported HRQoL and disease- and tx-related symptom data from the Phase II expansion cohorts. Methods: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30; scale range 0-100; functional and Global Health Status/QoL scales: high score = good HRQoL; symptom scale: high score = high level of symptoms) was used to assess HRQoL, physical, social, emotional, role, cognitive functioning and tx-related symptoms; and the Functional Assessment of Cancer Therapy-Lymphoma lymphoma subscale (FACT-Lym LymS; scale range 0-60; high score = good HRQoL) assessed symptoms of lymphoma in pts with R/R LBCL (≥2 prior LoT) treated with Glofit monotherapy in the Phase II expansion cohorts. Minimally important difference cutoffs were used to determine whether cohorts exhibited meaningful change on the QLQ-C30 scale (>10 points) and on the FACT-Lym LymS (≥3 points). The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was used to assess frequency, severity, interference, or presence/absence of tx-related symptoms. Symptoms were rated on a 5-point scale for each attribute. A subset of 6 symptoms (memory interference, headache, numbness and tingling, dizziness, hair loss, joint pain) deemed most applicable to the txs were selected for this study. Measures were completed on Day (D)1 of Cycles (C)1-3, 5, 7, 9, and 12 (during tx); at end of tx; and every 3 months after tx until progression. The PRO-CTCAE was also completed on C1D8, C1D15, and C2D8. Results: As of September 2023, 155 pts were enrolled (148 pts in expansion cohorts), with a median observation time of 32.1 months (range: 0-43). Median age was 66 years (range: 21-90) and pts received a medi