Real-World Effectiveness, Safety Economic Impact, and Humanistic Outcomes of Bispecific Antibodies (BsAbs) in Third-or-Later-Line (3L+) Treatment of Relapsed/Refractory (R/R) Large B-cell Lymphoma (LBCL): A Systematic Review and Meta-Analysis
Author(s)
Frederick L Locke, MD1, Chibuzo Iloabuchi, PhD2, Kristina B. Lindsley, PhD3, Markqayne Ray, MBA, PharmD2, Kushal Banerjee, PhD3, Kody Pierce, MBA, PharmD2, Yu Wang, PhD3, Tommy Lan, .3, David Cobley, PhD2, Jennifer Uyei, PhD3, Hil Hsu, PhD, MPH2, John G. Gribben, MD, DSc, FRCP, FRCPath, FMed Sci4.
1H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA, 2Kite, a Gilead Company, Santa Monica, CA, USA, 3IQVIA, Inc., San Francisco, CA, USA, 4Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.
1H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA, 2Kite, a Gilead Company, Santa Monica, CA, USA, 3IQVIA, Inc., San Francisco, CA, USA, 4Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.
OBJECTIVES: To examine the real-world effectiveness, safety, economic, and humanistic outcomes of BsAbs as 3L+ treatment for R/R LBCL.
METHODS: MEDLINE, Embase, conferences, and bibliographies were systematically searched (as of 29 April 2025) to identify real-world studies, published in English-language, of patients with R/R LBCL receiving 3L+ BsAbs (epcoritamab, glofitamab, or odronextamab). Outcomes included effectiveness, safety, economic, or humanistic outcomes. Meta-analysis used a random-effects model in R.
RESULTS: Of 20 studies included, 13 reported effectiveness and safety, 7 reported economic outcomes, and none reported humanistic outcomes. Twelve retrospective studies (9 evaluating glofitamab alone and 3 evaluating epcoritamab or glofitamab) provided data sufficient for meta-analysis (mean age=49-70 years; median prior lines-of-therapy=2.5-6; median follow-up=4.2-34 months). Study quality was generally fair. At 6 months, overall survival (OS) was 55% (95% confidence interval [CI]=47-62%; 5 studies; 168 patients) and progression-free survival (PFS) was 35% (95%CI=28-43%; 5 studies; 158 patients). At 12 months, OS=38% (95%CI=26-53%; 6 studies; 157 patients); PFS=29% (95%CI=21-40%; 6 studies; 176 patients). The objective response-rate was 50% (95%CI=44-55%; 12 studies; 513 patients) and complete-response was 29% (95%CI=22-38%; 12 studies; 514 patients). The proportion of patients with any-grade cytokine release syndrome (CRS) was 30-93% (10 studies); grade ≥2: 16-27% (5 studies); grade ≥3: 0-6% (8 studies). The proportion for any-grade immune cell-associated neurotoxicity syndrome (ICANS) was 0-17.4% (6 studies); grade ≥2: 0-5.7% (3 studies); grade ≥3: 0-1% (3 studies). Overall, 30-44% (4 studies) of all patients experienced any-grade infection; grade ≥3: 12-27.5% (4 studies); grade ≥2: 19-21% (2 studies). Additional findings, including economic outcomes, will be described in the presentation.
CONCLUSIONS: Real-world evidence suggests that while BsAbs provide moderate response rates in heavily pretreated R/R LBCL, 12-month survival remains below 40%, and adverse events, including CRS and infections, are common. These findings support the need for improved therapies and more robust real-world studies to inform clinical decisions.
METHODS: MEDLINE, Embase, conferences, and bibliographies were systematically searched (as of 29 April 2025) to identify real-world studies, published in English-language, of patients with R/R LBCL receiving 3L+ BsAbs (epcoritamab, glofitamab, or odronextamab). Outcomes included effectiveness, safety, economic, or humanistic outcomes. Meta-analysis used a random-effects model in R.
RESULTS: Of 20 studies included, 13 reported effectiveness and safety, 7 reported economic outcomes, and none reported humanistic outcomes. Twelve retrospective studies (9 evaluating glofitamab alone and 3 evaluating epcoritamab or glofitamab) provided data sufficient for meta-analysis (mean age=49-70 years; median prior lines-of-therapy=2.5-6; median follow-up=4.2-34 months). Study quality was generally fair. At 6 months, overall survival (OS) was 55% (95% confidence interval [CI]=47-62%; 5 studies; 168 patients) and progression-free survival (PFS) was 35% (95%CI=28-43%; 5 studies; 158 patients). At 12 months, OS=38% (95%CI=26-53%; 6 studies; 157 patients); PFS=29% (95%CI=21-40%; 6 studies; 176 patients). The objective response-rate was 50% (95%CI=44-55%; 12 studies; 513 patients) and complete-response was 29% (95%CI=22-38%; 12 studies; 514 patients). The proportion of patients with any-grade cytokine release syndrome (CRS) was 30-93% (10 studies); grade ≥2: 16-27% (5 studies); grade ≥3: 0-6% (8 studies). The proportion for any-grade immune cell-associated neurotoxicity syndrome (ICANS) was 0-17.4% (6 studies); grade ≥2: 0-5.7% (3 studies); grade ≥3: 0-1% (3 studies). Overall, 30-44% (4 studies) of all patients experienced any-grade infection; grade ≥3: 12-27.5% (4 studies); grade ≥2: 19-21% (2 studies). Additional findings, including economic outcomes, will be described in the presentation.
CONCLUSIONS: Real-world evidence suggests that while BsAbs provide moderate response rates in heavily pretreated R/R LBCL, 12-month survival remains below 40%, and adverse events, including CRS and infections, are common. These findings support the need for improved therapies and more robust real-world studies to inform clinical decisions.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PT6
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Clinical Outcomes Assessment
Disease
Biologics & Biosimilars, Oncology