Background: Patients (pts) with lymphoma have reduced health-related quality of life (HRQoL) due to disease- and treatment-related symptoms, which declines at the time of progression and with further lines of treatment. Glofitamab (Glofit) is the first CD20xCD3 bispecific antibody to demonstrate survival benefit in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in a randomized Phase III trial (STARGLO; NCT04408638). In this study, Glofit-GemOx showed statistically significant benefit in overall and progression-free survival, as well as complete response rate, over R-GemOx in pts with R/R DLBCL who were ineligible for autologous stem cell transplant (Abramson, et al. EHA 2024). Here, we use patient-reported outcomes (PRO) to capture the impact of treatment on HRQoL in pts from the STARGLO trial.
Methods: Pts were randomized 2:1 to receive either Glofit-GemOx (8 cycles, plus 4 cycles of Glofit monotherapy) or R-GemOx (8 cycles). HRQoL was measured using the Functional Assessment of Cancer Treatment-Lymphoma Lymphoma Subscale (FACT-Lym LYMS; scale range 0-60; high score = less lymphoma symptoms) for lymphoma symptoms and the European Organization for Research and Treatment of Cancer Quality of Life-Core 30 questionnaire (EORTC QLQ-C30; scale range 0-100; high score = better functioning and worse symptoms) for functioning and generic symptom scales. Pts completed questionnaires during treatment (Day 1 of Cycles [C]1-5, 7, 9 and 11), at end of treatment (EOT), and every 3 months until death or loss to follow-up. Questionnaire compliance, time to deterioration (TTD), change from baseline (CfB) and summary statistics were estimated at each assessment time point. For TTD analyses, clinically meaningful worsening from baseline for physical functioning (≥10-point decrease), fatigue (≥10-point increase), and lymphoma symptom scores (≥3-point decrease) were reported based on validated thresholds.
Results: In total, 274 pts with DLBCL were enrolled (Glofit-GemOx, n=183; R-GemOx, n=91); 172 (62.8%) after 1 prior therapy and 102 (37.2%) after ≥2 prior therapies. Overall, 153 (55.8%) pts had primary refractory disease, and 166 (60.6%) pts were refractory to last therapy. PRO questionnaire response rates were high (>95%) while on treatment.
At baseline, pts in both arms reported moderate-to-high functioning, mild impairment in global health status/QoL, and low to low-moderate levels of lymphoma symptoms as assessed by the FACT-Lym LYMS, as well as low-to-mild symptom severity as measured by the EORTC QLQ-C30.
The median TTD was comparable between arms (Glofit-GemOx vs R-GemOx) for fatigue (1.6 vs 4.0 months), physical functioning (23.0 vs 18.0 months), and lymphoma symptoms (6.2 vs 4.5 months). At C3, CfB improvements in pain (Glofit-GemOx: −11.38; R-GemOx: −6.67) and lymphoma symptoms (Glofit-GemOx: 3.14; R-GemOx: 0.87) for Glofit-GemOx surpassed the minimal clinically important difference (MCID; pain: −10.0; lymphoma symptoms: 3.0). By C5, improvements continued to surpass the MCID in both arms; mean CfB in the Glofit-GemOx and R-GemOx arms were −12.33 and −12.75 for pain, and 2.27 vs 5.92 for lymphoma symptoms, respectively. At EOT, both arms had sustained improvements in overall pain scores (Glofit-GemOx: 15.94; R-GemOx: 28.04) and lymphoma symptom scores (Glofit-GemOx: 48.78; R-GemOx: 45.13), with pts in the Glofit-GemOx arm reporting less pain and fewer lymphoma symptoms than those in the R-GemOx arm.
Conclusions: In the STARGLO study, HRQoL results were comparable between arms, even with a longer treatment period and higher rates of adverse events in the Glofit-GemOx arm. Together with the significant survival benefit conferred on pts with Glofit-GemOx over R-GemOx observed in the STARGLO trial, these HRQoL data further support the use of Glofit-GemOx as a new treatment option for pts with R/R DLBCL.
Gregory:Roche, Merck: Speakers Bureau; Merck, Amgen, Roche, Novartis, BMS, Clinigen, Gilead, Prelude Therapeutics: Membership on an entity's Board of Directors or advisory committees; Merck, BeiGene (to institute, not individual): Research Funding. Abramson:Bristol Myers Squibb: Consultancy, Research Funding; Cellectis: Research Funding; Merck: Research Funding; Mustang Bio: Research Funding; Seagen Inc.: Research Funding; Interius BioTh: Consultancy; Incyte Corporation: Consultancy; Genmab US Inc: Consultancy; Genentech, a member of the Roche Group: Consultancy; AstraZeneca Pharmaceuticals LP: Consultancy; BeiGene Ltd: Consultancy; Caribou Biosciences Inc: Consultancy; Century Therapeutics: Consultancy; Epizyme Inc: Consultancy; AbbVie Inc: Consultancy; Foresight Diagnostics: Consultancy. Ku:Roche, Abbvie: Consultancy; F. Hoffmann-La Roche Ltd, AbbVie: Consultancy; Beigene: Research Funding; St Vincent's Hospital, Melbourne: Current Employment. Yoon:Regeneron: Membership on an entity's Board of Directors or advisory committees; Asan Medical Center, University of Ulsan College of Medicine: Current Employment; Abbvie, Beigene, Boryung, Celltrion, Kyowa Kirin, Janssen, Samyang and Sanofi: Honoraria, Research Funding; Abbvie, Abclon, Beigene, BMS, GI cell, GI innovation, GC cell, Verismo, Janssen, Lilly, Novartis, Roche, and Pharos Bio: Consultancy. Fox:BeiGene, AbbVie: Research Funding; AbbVie, AstraZeneca, Atarabio, BMS, GenMab, Gilead/Kite, Incyte, Janssen, Lilly, Morphosys, Ono, Roche, SERB, SOBI, Takeda: Consultancy, Honoraria. Abdulhaq:Genentech, Amgen, Abbvie: Consultancy; Morphosys, Novartis, BMS, Genentech, Pfizer, Acrotech, Amgen: Honoraria; Genentech: Speakers Bureau; Morphosys, Novartis, BMS, Genentech, Pfizer, Acrotech, Amgen: Membership on an entity's Board of Directors or advisory committees. Townsend:Research funding paid to my institution (UCL) by Roche: Research Funding; Roche, Abbvie, Sobi, Kite, Takeda: Consultancy; Roche, Abbvie, Sobi, Kite, Takeda, Janssen: Honoraria; Roche, Abbvie, Takeda, Sobi: Membership on an entity's Board of Directors or advisory committees, Other: Travel to international conferences from Roche. Ashby:Roche/Genentech: Current Employment; Roche/Genentech stock: Current equity holder in publicly-traded company. Harris:Roche Products Ltd: Current Employment; Roche: Current equity holder in publicly-traded company. Orellana-Noia:Genentech, Inc.: Current Employment; F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company. Simko:Genentech, Inc.: Current Employment; Roche Holding AG: Current equity holder in publicly-traded company; Apple, Inc.: Current equity holder in publicly-traded company. Kallemeijn:F. Hoffmann-La Roche Ltd: Current Employment. Ta:Genentech/Roche: Current Employment. Relf:Roche, F Star Therapeutics: Divested equity in a private or publicly-traded company in the past 24 months; Roche Products Limited: Current Employment; Roche: Current equity holder in publicly-traded company. Huang:Hoffmann-La Roche Limited: Current Employment. Lundberg:F. Hoffmann-La Roche Ltd: Current Employment, Current equity holder in publicly-traded company, Current holder of stock options in a privately-held company, Patents & Royalties.
Glofitamab (Columvi) is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory DLBCL, NOS or large B-cell lymphoma arising from FL, after two or more lines of systemic therapy.Rituximab (Rituxan) is a CD20-directed cytolytic antibody indicated for the treatment of adult pts with: relapsed or refractory, low grade or follicular, CD20-positive, B-cell NHL as a single agent; previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy (chemo) and, in pts achieving a CR or PR to a rituximab product in combination with chemo, as single-agent maintenance therapy; non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line CVP chemo; previously untreated diffuse large B-cell, CD20-positive, NHL in combination with CHOP or other anthracycline-based chemo regimens; previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide. Rituxan Hycela is a combination of rituximab, a CD20-directed cytolytic antibody, and hyaluronidase human, an endoglycosidase, indicated for the treatment of adult pts with: relapsed or refractory FL as a single agent; previously untreated FL in combination with first-line chemotherapy (chemo); a CR or PR to rituximab in combination with chemo, as single agent maintenance therapy; non-progressing (including stable disease) FL, as a single agent after first-line CVP chemo; previously untreated DLBCL in combination with CHOP or other anthracycline-based chemo regimens; previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide.
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