# Safety and efficacy of odronextamab in patients with relapsed or refractory follicular lymphoma

Source: https://onco.cc/key-papers/paper-elm-2-odronextamab-follicular-ann-oncol-2024/  
OnCo record `paper-elm-2-odronextamab-follicular-ann-oncol-2024` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A two-headed antibody given alone put nearly three quarters of people with repeatedly relapsed follicular lymphoma into complete remission, lasting a median of two years.

## Summary

The follicular lymphoma cohort of the phase 2 ELM-2 study of odronextamab, a CD20 by CD3 bispecific antibody, in patients with relapsed or refractory disease after two or more lines of systemic therapy. Odronextamab was given intravenously in 21-day cycles with step-up dosing in cycle 1 to mitigate cytokine release syndrome, until disease progression or unacceptable toxicity. The primary endpoint was objective response rate by independent central review.

128 patients were evaluated, of whom 95 per cent completed cycle 1 and 85 per cent four or more cycles. At 20.1 months of efficacy follow-up, the objective response rate was 80.0 per cent and the complete response rate 73.4 per cent. Median duration of complete response was 25.1 months, median progression-free survival 20.7 months, and median overall survival was not reached. Discontinuation for adverse events occurred in 16 per cent. The commonest treatment-emergent adverse events were cytokine release syndrome in 56 per cent, with grade 3 or above in 1.7 per cent (one of 60 patients) using the 0.7, 4 and 20 milligram step-up, neutropenia in 39 per cent and pyrexia in 38 per cent.

## Fields

- Kind: Key paper
- Last checked: 2026-10-01
- Also known as: ELM-2; Kim 2024; Odronextamab in follicular lymphoma
- Tags: lymphoma-evidence
- Journal: Annals of Oncology
- Year: 2024
- DOI: 10.1016/j.annonc.2024.08.2239
- Authors: Kim TM, Taszner M, Novelli S, et al.
- Findings: The objective response rate was 80.0 per cent and the complete response rate 73.4 per cent among 128 evaluated patients.; Median duration of complete response was 25.1 months and median progression-free survival 20.7 months; median overall survival was not reached.; Cytokine release syndrome occurred in 56 per cent, with grade 3 or above in 1.7 per cent using the 0.7, 4 and 20 milligram step-up schedule.; 16 per cent discontinued odronextamab because of adverse events.; 95 per cent of patients completed cycle 1 and 85 per cent completed four or more cycles.
- What it means: An off-the-shelf alternative to CAR-T for repeatedly relapsed follicular lymphoma: no apheresis, no manufacturing wait, and a complete response rate in the same range, at the cost of continued treatment rather than a single infusion.
- Caveats: Single-arm, so the comparison with CAR-T and with the other bispecific antibodies is cross-trial.; The cytokine release syndrome figures depend on the step-up schedule used, which changed during the study.; Treatment continues until progression or toxicity, rather than for a fixed duration as with mosunetuzumab, which matters for cost and for time spent in hospital.

## Sources

- Annals of Oncology 2024: https://doi.org/10.1016/j.annonc.2024.08.2239
- PubMed: https://pubmed.ncbi.nlm.nih.gov/39147364/
- Europe PMC: https://europepmc.org/article/MED/39147364

## Connected records

- roadmaps: [Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting](https://onco.cc/roadmaps/lymphoma-roadmap/)
- cancers: [Follicular lymphoma](https://onco.cc/cancers/follicular-lymphoma/), [Non-Hodgkin lymphoma (all types)](https://onco.cc/cancers/non-hodgkin-lymphoma/)
- fronts: [Immunotherapy](https://onco.cc/fronts/immunotherapy/)
- technologies: [Bispecific antibodies](https://onco.cc/technologies/bispecific-antibody/), [T-cell engagers (bispecific)](https://onco.cc/technologies/t-cell-engager/)
- targets: [CD20](https://onco.cc/targets/cd20/), [CD3](https://onco.cc/targets/cd3/)
- drugs: [Odronextamab](https://onco.cc/drugs/odronextamab/)
- companies: [Regeneron](https://onco.cc/companies/regeneron/)
- terms: [Complete response](https://onco.cc/terms/complete-response/), [Cytokine release syndrome (CRS)](https://onco.cc/terms/crs/), [Objective response rate (ORR)](https://onco.cc/terms/orr/)
- trials: [A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treat](https://onco.cc/trials/nct03888105/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/), [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/)
- journals: [Annals of Oncology](https://onco.cc/journals/annals-of-oncology/)
- ideas: [Fixed-duration, chemotherapy-free first-line treatment for the indolent lymphomas](https://onco.cc/ideas/lymphoma-ev-fixed-duration-chemotherapy-free-first-line/)

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