Clinical lymphoma, myeloma & leukemia · 2025
Epcoritamab Plus Gemcitabine and Oxaliplatin Versus Rituximab Plus Gemcitabine and Oxaliplatin in Transplant-Ineligible Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Match-Adjusted Comparative Analysis.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Munoz Javier, Rosenthal Allison, Ip Andrew, Darrah Justin M, Wang Tongsheng, Zhang Guihua, Mutebi Alex, Branchcomb Tychell, Ding Zhijie, Chhibber Anindit, Navarro Fernando Rivas, Risum Malene, Atiya Mohammad, Brodkin Samantha, Wang Anthony, Alshreef Abualbishr, Harb Diala, Sacchi Mariana, Hoehn Daniela, Karimi Yasmin H
Аннотация
BACKGROUND: This indirect treatment comparison evaluated epcoritamab plus gemcitabine and oxaliplatin (Epcor+GemOx) versus rituximab (R)-GemOx in patients with transplant-ineligible relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
METHODS: Individual patient data (IPD) for Epcor+GemOx from EPCORE NHL-2 Arm 5 (NCT04663347) were compared with clinical practice data for patients treated with R-GemOx using 2 methodologies: a matching-adjusted indirect comparison (MAIC) using published aggregate data from clinical sites in France (Cazelles et al. Lymphoma. 2021;62:2161) and inverse probability of treatment weighting (IPTW) using IPD from the US-based COTA database (COTA Healthcare). Outcomes included objective response rate (ORR), complete response (CR) rate, progression-free survival (PFS), and overall survival (OS).
RESULTS: In the MAIC, after adjustment, Epcor+GemOx versus R-GemOx had significantly higher ORR (86.8% vs 38.3%; relative risk [RR], 2.27 [95% confidence interval (CI), 1.76-2.93]; P < .0001) and CR rate (71.2% vs 32.7%; RR, 2.18 [95% CI, 1.61-2.96]; P < .0001). Median PFS was 26.7 versus 4.8 months (hazard ratio [HR], 0.38 [95% CI, 0.22-0.67]; P < .001); median OS was not reached with Epcor+GemOx versus 10.0 months with R-GemOx (HR, 0.54 [95% CI, 0.29-1.00]; P = .05). In the IPTW, Epcor+GemOx versus R-GemOx had significantly higher ORR (88.5% vs 35.6%; RR, 2.48 [95% CI, 1.80-3.43]; P < .0001), CR rate (63.9% vs 10.2%; RR, 6.25 [95% CI, 3.08-12.68]; P < .0001), median PFS (11.2 vs 2.4 months; HR, 0.23 [95% CI, 0.15-0.36]; P < .001), and median OS (21.6 vs 8.3 months; HR, 0.47 [95% CI, 0.30-0.74]; P = .002).
CONCLUSION: Epcor+GemOx provides significantly greater response rates and survival outcomes compared with R-GemOx in patients with transplant-ineligible R/R DLBCL.
METHODS: Individual patient data (IPD) for Epcor+GemOx from EPCORE NHL-2 Arm 5 (NCT04663347) were compared with clinical practice data for patients treated with R-GemOx using 2 methodologies: a matching-adjusted indirect comparison (MAIC) using published aggregate data from clinical sites in France (Cazelles et al. Lymphoma. 2021;62:2161) and inverse probability of treatment weighting (IPTW) using IPD from the US-based COTA database (COTA Healthcare). Outcomes included objective response rate (ORR), complete response (CR) rate, progression-free survival (PFS), and overall survival (OS).
RESULTS: In the MAIC, after adjustment, Epcor+GemOx versus R-GemOx had significantly higher ORR (86.8% vs 38.3%; relative risk [RR], 2.27 [95% confidence interval (CI), 1.76-2.93]; P < .0001) and CR rate (71.2% vs 32.7%; RR, 2.18 [95% CI, 1.61-2.96]; P < .0001). Median PFS was 26.7 versus 4.8 months (hazard ratio [HR], 0.38 [95% CI, 0.22-0.67]; P < .001); median OS was not reached with Epcor+GemOx versus 10.0 months with R-GemOx (HR, 0.54 [95% CI, 0.29-1.00]; P = .05). In the IPTW, Epcor+GemOx versus R-GemOx had significantly higher ORR (88.5% vs 35.6%; RR, 2.48 [95% CI, 1.80-3.43]; P < .0001), CR rate (63.9% vs 10.2%; RR, 6.25 [95% CI, 3.08-12.68]; P < .0001), median PFS (11.2 vs 2.4 months; HR, 0.23 [95% CI, 0.15-0.36]; P < .001), and median OS (21.6 vs 8.3 months; HR, 0.47 [95% CI, 0.30-0.74]; P = .002).
CONCLUSION: Epcor+GemOx provides significantly greater response rates and survival outcomes compared with R-GemOx in patients with transplant-ineligible R/R DLBCL.