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.

[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.