Odronextamab Trial: Striking Response Rates and Enduring Outcomes in High-Risk R/R DLBCL Subgroups

Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing. The primary analysis of the Phase II trial presented at the ASH 2023 demonstrated that, among 127 DLBCL patients treated with odronextamab, the reported objective response rate (ORR) was 52%, with 31% achieving a complete response (CR). Moreover, the responses were observed across high-risk subgroups, including those with International Prognosis Index (IPI) high-risk scores of 3 to 5, high-grade lymphoma that is double-hit and triple-hit, and transformed DLBCL. Furthermore, the median duration of response (DoR) was 10 months with a 30-month median duration of follow-up for efficacy-evaluable patients.

In terms of safety assessment, the most frequently occurring adverse events (AE) in over 30% of patients included cytokine release syndrome (CRS; 55%), fever (pyrexia; 43%), anemia (39%), and neutropenia (31%). Among the 60 patients who underwent the recommended step-up regimen, 53% encountered cytokine release syndrome (CRS). All instances were successfully addressed with supportive measures, with a median duration of 2 days. Within this group, 40% (n=24) experienced Grade 1 CRS, 12% (n=7) had Grade 2 CRS, and 2% (n=1) had Grade 3 CRS.

Odronextamab is currently under regulatory review for the treatment of R/R DLBCL and R/R FL by the U.S. Food and Drug Administration (FDA), with a target action date of March 31, 2024, as well as by the European Medicines Agency (EMA).

 KOL Insights

“Diffuse large B-cell lymphoma has a high risk of relapse, which is why it is so critical to demonstrate continued disease control over the long term. The totality of the odronextamab data at ASH reinforces its potential as a promising treatment option for patients with this aggressive blood cancer.” –Expert Opinion.

Conclusion

The key findings from the pivotal odronextamab trial demonstrated remarkable response rates, particularly within specific high-risk subgroups. Additionally, these responses exhibited durability and alignment with the outcomes observed in a Phase I trial involving patients who had previously experienced progression on CAR-T therapy.

Refer to the Related Reports for More In-depth Insights –