ELM-2: Survival benefit for patients with FL on odronextamab

After a 2-year follow-up, odronextamab was associated with deep and durable responses in patients with relapsed or refractory follicular lymphoma (FL). A manageable safety profile further supports the potential of this agent in heavily pre-treated patients with FL.

The phase 2 ELM-2 trial was designed to test the safety and efficacy of the CD20xCD3 bispecific antibody odronextamab in patients with relapsed or refractory FL, and the primary analysis delivered positive results [1]. Prof. Stefano Luminari (University of Modena and Reggio Emilia, Italy) discussed outcomes after 2 years of follow-up, including data from 157 patients [2].

The observed overall response rate was 80.5%, and the complete response rate was 74.2%. Also, the responses were durable, with a median duration of response of 26.0 months. Prof. Luminari mentioned that the median progression-free survival was 23.0 months and that the median overall survival was 54.2 months. “The median progression-free survival was longer in participants who reached MRD negativity at week 12 [42.4 vs 21.6 months],” highlighted Prof. Luminari.

No new safety issues emerged with longer follow-up. Grade 3 or higher adverse events (AEs) were seen in 86.0% of the participants, and 15.3% discontinued the study due to AEs. Serious infections were common (45.2%), and COVID-19 was reported in 38.2% of the participants.

“These findings show that the efficacy of odronextamab is robust and that the safety profile is manageable,” concluded Prof. Luminari. “Many of these heavily pre-treated patients experienced an overall survival benefit with odronextamab.”

1. Kim TM, et al. Ann Oncol. 2024;35(11):1039-1047.
2. Luminari S, et al. Long-term efficacy and survival outcomes with odronextamab for patients with relapsed/refractory follicular lymphoma: 2-year follow-up from the phase 2 ELM-2 study. S235, EHA2025 Congress, 12–15 June, Milan, Italy.

Medical writing support was provided by Robert van den Heuvel.
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Posted on 18 June 20252 September 2025