Final Analysis of the Phase 2 ELM-2 Study: Odronextamab in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)

作者：Sabarish Ayyappan, Won Seog Kim, Tae Min Kim, Jan Walewski, Seok‐Goo Cho, Isidro Jarque, Elżbieta Iskierka‐Jazdzewska, Michelle Poon, Sung Yong Oh, Francesca Lim, Cecilia Carpio, Tran‐Der Tan, Antonio Gutiérrez, Huilai Zhang, Junning Cao, Mingzhi Zhang, Benoît Tessoulin, Jingjin Li, Melanie Ufkin, Saleem Shariff, Lei Chi, Aafia Chaudhry, Hesham Mohamed, Srikanth Ambati, H. Miles Prince · 发表于：Blood · 年份：2023 · DOI：10.1182/blood-2023-179818 · 被引用次数：50 · 研究领域：CAR-T cell therapy research、Integrated Circuits and Semiconductor Failure Analysis、Lymphoma Diagnosis and Treatment

Background Odronextamab is a novel, off-the-shelf, CD20×CD3 bispecific antibody that has demonstrated consistent anti-lymphoma activity and a generally manageable safety profile in heavily pretreated patients (pts) with both R/R follicular lymphoma and R/R DLBCL. Encouraging results have been reported in pts who have relapsed following chimeric antigen receptor (CAR) T-cell therapy in the Phase 1 ELM-1 study, and in pts with R/R DLBCL in the Phase 2 ELM-2 study (Kim WS, et al. ASH. 2022). Here, we present the final analysis of the R/R DLBCL cohort from ELM-2 (NCT03888105), reporting long-term efficacy and safety outcomes. Methods Intravenous odronextamab was administered weekly in 21-day cycles during Cycles (C) 1-4. Optimization of the step-up regimen to further mitigate cytokine release syndrome (CRS) was reported previously (Kim WS, et al. ASH 2022). Odronextamab was administered with steroid prophylaxis and step-up doses of 0.7/4/20 mg during C1, followed by 160 mg on Days 1, 8, and 15 of C2-4. After C4, odronextamab maintenance treatment continued at 320 mg every 2 weeks until disease progression or unacceptable toxicity. Pts who achieved a complete response (CR) that was durable for ≥9 months transitioned to dosing every 4 weeks. The final analysis was performed when all pts had the opportunity for ≥36 weeks of follow-up. The primary endpoint was objective response rate (ORR), assessed by independent central review (ICR) according to the Lugano classification. Key secon...