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"The objective response rate was 77.1%, and all [patients] achieved CR by investigator assessment. [The] safety profile is consistent with what has been reported in [previous analyses].”

Tae Min Kim, MD, PhD, professor, oncology, Seoul National University Hospital, discusses findings from the phase 2 ELM-2 study (NCT03888105), the first investigation of odronextamab (Ordspono), a bispecific antibody targeting CD20 and CD3, as monotherapy in patients with relapsed/refractory marginal zone lymphoma (MZL). This multicenter trial evaluated the efficacy and safety of odronextamab in heavily pretreated patients across various B-cell non-Hodgkin lymphoma (NHL) subtypes, including MZL.

The relapsed/refractory MZL cohort had promising clinical outcomes with odronextamab, with an objective response rate of 77.1% (95% CI, 59.9%-89.6%), including a complete response (CR) rate of 100% among responders. Response rates were consistent across MZL subtypes and comparable with those observed in patients with relapsed/refractory follicular lymphoma in the broader ELM-2 study. Responses were durable, and the median duration of response and duration of complete response were not yet reached at a median follow-up of 11.1 months (95% CI, 6.2-42.8).

Odronextamab was associated with a manageable safety profile, consistent with prior data in indolent B-cell NHLs, according to Kim. All cytokine release syndrome events were grade 1 or 2, and no cases of immune effector cell–associated neurotoxicity syndrome were reported. The most common grade 3 or higher treatment-emergent adverse effects included neutropenia (23.8%), elevated alanine aminotransferase levels (16.7%), elevated aspartate aminotransferase levels (16.7%), and anemia (11.9%). No new safety signals were identified, supporting the tolerability of odronextamab in this patient population.

These findings establish odronextamab as a potentially effective therapy for patients with relapsed/refractory MZL who have limited treatment options following standard-of-care therapies, Kim says. Building on these results, enrollment is ongoing for the phase 3 OLYMPIA-5 trial (NCT06149286) evaluating odronextamab in combination with lenalidomide (Revlimid) vs rituximab (Rituxan) plus lenalidomide in patients with relapsed/refractory follicular lymphoma and MZL.

Kim emphasizes the importance of these findings in addressing the unmet needs of this patient population, particularly given the high CR rates and manageable safety profile demonstrated in the ELM-2 study. Future studies aim to validate these results and further explore odronextamab’s role in earlier lines of therapy and in combination regimens to optimize treatment outcomes for patients with relapsed/refractory MZL.

Videos

Tae Min Kim, MD, PhD, discusses the efficacy of odronextamab monotherapy in patients with relapsed/refractory marginal zone lymphoma.

Tae Min Kim, MD, PhD

Articles

Dr Kim on The Efficacy and Safety of Odronextamab in R/R MZL