Dr Brem on Odronextamab in Previously Untreated Patients, High-Risk Follicular Lymphoma

“Overall, we were very encouraged by the efficacy. We're really eager to see how that translates into progression-free survival, and the overall safety and tolerability looked really excellent, as well.”

Elizabeth A. Brem, MD, associate clinical professor, medicine, University of California Irvine, discusses results from the safety lead-in portion of the phase 3 OLYMPIA-1 trial (NCT06091254) evaluating odronextamab monotherapy in previously untreated patients with high-risk follicular lymphoma. The initial analysis presented at the 2024 ASH Annual Meeting focused on patients (n = 13) receiving odronextamab to assess safety and early efficacy prior to advancing into the randomized phase of the study.

Data demonstrated that odronextamab administered in an outpatient setting was feasible and well-tolerated. No dose-limiting toxicities (DLTs) were observed. Cytokine release syndrome (CRS) occurred in 61.5% of patients; however, all instances of CRS were grade 1.

Importantly, no instances of immune effector cell–associated neurotoxicity syndrome (ICANS) were reported. Grade 3 infections were reported in 2patients (15.4%), but no grade 4 or 5 infections occurred, and no patients discontinued therapy due to infection-related adverse effects.

Efficacy data showed that the overall response rate (ORR) and complete response (CR) rate were both 92.3%. Notably, the only patient (7.7%) to not achieve a response was not evaluable. The median duration of response was 3.1 months (95% CI, 2.8-5.6).

Enrollment for Part 2 of the OLYMPIA-1 trial is ongoing using a recommended phase 3 dose of odronextamab at 80 mg, based on findings from the safety lead-in. The randomized portion of the study is evaluating odronextamab vs rituximab (Rituxan) plus chemotherapy induction, followed by rituximab maintenance.