Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Hematology Disease Topics & Pathways:
Biological therapies, Antibody Therapy, Research, Lymphomas, non-Hodgkin lymphoma, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Clinical Research, health outcomes research, Diseases, Therapies, real-world evidence, Lymphoid Malignancies
Methods: Published data on the overall response rate (ORR), complete response (CR) rate, digitized progression-free survival (PFS), and overall survival (OS) for tisa-cel from JULIET publications were used in MAIC vs individual patient-level data (IPD) of CAR T-naive and CAR T-eligible patients from EPCORE NHL-1 (Nov 2022 data cut). Analyses were adjusted for imbalances in the following baseline characteristics between IPD from EPCORE NHL-1 and aggregate data from JULIET: age 65 years or older, gender, Eastern Cooperative Oncology Group performance status, disease stage, DLBCL, refractory to last therapy, and prior autologous stem cell transplant. Kaplan-Meier methodology was used to estimate survival.
Results: A total of 96 CAR T-naive patients from EPCORE NHL-1 were included in the analysis, with an effective sample size of 33 CAR T-naive patients after adjustment. The CAR T-eligible subgroup from EPCORE NHL-1 included 57 patients with an effective sample size of 21 patients after adjustment. After adjustment there was a significant difference in ORR for epcoritamab vs tisa-cel (77.9% vs 53.0%, respectively; difference [95% confidence interval (CI)]: 24.8% [9.5, 40.2]; P=0.002) in the CAR T-naive cohort, and in CR rate (52.3% vs 39.1%, respectively; difference [95% CI]: 13.2% [ 5.9, 32.3]; P=0.174). Also, in the CAR T-naive cohort there was a trend toward PFS benefit for epcoritamab vs tisa-cel after adjustment (hazard ratio [HR]: 0.725; 95% CI: 0.447, 1.177; P=0.194) and OS (HR: 0.611; 95% CI: 0.356, 1.049; P=0.074). In the CAR T-eligible subgroup there was a significant difference in ORR (80.8% vs 53.0%, respectively; difference [95% CI] 27.7% [11.0, 44.4]; P=0.001) and CR rate (61.9% vs 39.1%, respectively; difference [95% CI]: 22.8% [1.5, 44.1]; P=0.036) for epcoritamab vs tisa-cel after adjustment. Also, there was a statistically significant survival benefit for OS (HR: 0.450; 95% CI: 0.227, 0.891; P=0.022) and a numerical trend toward benefit for PFS (HR: 0.548; 95% CI: 0.300, 1.003; P=0.051) when comparing epcoritamab vs tisa-cel after adjustment.
Conclusion: In the absence of head-to-head data, this MAIC of the R/R LBCL CAR T-naive cohort and the eligible subgroup treated with epcoritamab vs tisa-cel demonstrated improved response rates and survival outcomes. This study underscores the therapeutic potential of epcoritamab as a novel, subcutaneous, off-the-shelf, core therapy for the treatments of patients with R/R LBCL. Indirect comparisons can be biased by cross-trial differences and further comparisons with longer follow-up are warranted.
Disclosures: Salles: Owkin: Current holder of stock options in a privately-held company; Nordic Nanovector: Consultancy; Nurix: Consultancy; Orna: Consultancy; Novartis: Consultancy; Merck: Consultancy, Honoraria; Kite/Gilead: Consultancy; ATB Therapeutics: Consultancy; Loxo/Lilly: Consultancy; BMS/Celgene: Consultancy; BeiGene: Consultancy; Debiopharm: Consultancy; AbbVie: Consultancy, Honoraria; Ipsen: Consultancy, Research Funding; Molecular Partners: Consultancy; EPIZYME: Consultancy; Genentech, Inc./F. Hoffmann-La Roche Ltd: Consultancy, Research Funding; Janssen: Consultancy, Research Funding; Incyte: Consultancy; Genmab: Consultancy. Fox: Genmab: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy. Wang: AbbVie: Current Employment, Current holder of stock options in a privately-held company. Sail: AbbVie: Current Employment, Current holder of stock options in a privately-held company. Alshreef: AbbVie: Current Employment, Current holder of stock options in a privately-held company. Moran: AbbVie: Current Employment. Mutebi: Genmab: Current Employment, Current holder of stock options in a privately-held company. Blaedel: Genmab: Current Employment, Current holder of stock options in a privately-held company. Chirikov: OPEN Health: Current Employment. Wang: OPEN Health: Current Employment. Thieblemont: Kyte, Gilead, Novartis, BMS, Abbvie, F. Hoffmann-La Roche Ltd, Amgen: Honoraria; Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel Expenses, Research Funding; Paris University, Assistance Publique, hopitaux de Paris (APHP): Current Employment; Bayer: Honoraria; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Kite: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Expenses; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Expenses; Gilead Sciences: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Expenses; Hospira: Research Funding; Cellectis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Expenses; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Expenses; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Expenses; BMS/Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel Expenses, Research Funding; Janssen: Honoraria, Other: Travel Expenses.
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