Follicular lymphoma (FL) is a chronic disease that accounts for about 20% of non-Hodgkin’s lymphoma (NHL) cases.

Relapsed/refractory (R/R) FL has a progressively worsening prognosis with each subsequent relapse and no curative treatment options.

The early results of the Phase II ELM-2 trial evaluating Regeneron’s odronextamab as a new treatment for R/R FL were presented at the European Hematology Association Congress (EHA2024).

Odronextamab is a novel bispecific T-cell engager (BiTE) that targets CD20 on B cells and CD3 on T cells, providing T-cell-mediated cytotoxicity towards cancer cells.

In the ELM-2 trial, 128 heavily pretreated R/R FL patients received intravenous odronextamab in 21-day cycles until disease progression or intolerable toxicity.

At a median efficacy follow-up of 20 months, the objective response rate was 80.5% and the complete response (CR) rate was 73.4%, indicating that most patients achieved significant tumour reduction.

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The responses were notably durable, with a median duration of response of 21 months and a median duration of CR at 23 months.

Furthermore, the median progression-free survival (PFS) was 21 months in all patients, and the 24-month PFS rate was 46.1%.

While the median overall survival (OS) was not reached, the 24-month OS rate was 81% in patients with CR, suggesting potential long-term survival benefit.

The safety analysis showed that all patients suffered treatment-emergent adverse events (AEs), with 85.9% experiencing grade ≥3 AEs.

Despite the high incidence of AEs, the safety profile was considered tolerable, with just 15.6% of patients terminating therapy due to AEs.

Cytokine release syndrome (CRS), which is associated with bispecific antibodies, was often mild and resolved within two days, and immune effector cell-associated neurotoxicity syndrome occurred in one patient.

Leading data and analytics company GlobalData estimates that by 2027, the number of active FL cases will reach 58,194 in the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan).

This sizable patient population with significant unmet medical needs creates an exciting market opportunity for odronextamab.

Regeneron is continuing its extensive OLYMPIA programme, which includes odronextamab, with ten ongoing and two planned Phase I-III clinical trials in NHL, addressing the US Food and Drug Administration’s requirement for the trials to include both dose-finding and confirmatory parts.

However, odronextamab, if approved, will face fierce competition with two other BiTEs, AbbVie and Genmab’s Epkinly and Genentech’s Lunsumio.

According to GlobalData’s analyst consensus forecast, odronextamab’s global sales will reach $563m by 2030, lagging behind Epkinly with more than $2.5bn, and Lunsumio reaching nearly $1bn in global sales by 2030, despite the latter two drugs holding boxed warnings for CRS.

Note: The seventh paragraph has been updated to reflect the correct median duration of a complete response.