OLYMPIA-1 Trial: Odronextamab Demonstrates 100% ORR, CR Rate in High-Risk Follicular Lymphoma

Odronextamab monotherapy showed promising efficacy in patients with high-risk, grade 1-3a follicular lymphoma (FL), according to results from the phase III Olympia-1 study presented at the 66^th American Society of Hematology Annual Meeting & Exposition.

Thirteen adult patients (median age, 62 years) received intravenous odronextamab for six 21-day cycles. To reduce the risk of cytokine release syndrome (CRS), patients also received steroid prophylaxis during step-up dosing (0.7 mg, 4 mg, and 20 mg) in cycle 1.

Patients subsequently received odronextamab at 80 mg in cycles 2-4 and 160 mg in cycles 5-6. The median duration of exposure was 3.05 weeks (1.7–8.7). Those who achieved a complete response (CR) or partial response after cycle 6 received fixed-dose maintenance therapy, which consisted of 12 doses of odronextamab at 320 mg every eight weeks.

Among five evaluable patients, the ORR and CR rate were both 100%. The researchers did not observe any dose-limiting toxicities, but all 13 patients experienced treatment-emergent adverse events (TEAEs) such as diarrhea (n=6), rash (n=5), and grade 1 CRS (n=4). Five patients experienced grade 3 or more TEAEs.

“Based on the prespecified criteria for assessment of safety of odronextamab monotherapy in part one, enrollment is proceeding for part two of OLYMPIA-1, with a recommended phase III dose of 80 mg,” the researchers concluded.

Reference

Brem E, Jurczak W, Belada D, et al. “Odronextamab monotherapy in previously untreated patients with high-risk follicular lymphoma (FL): results of the safety lead-in of the phase 3 olympia-1 study.” Abstract #4411. Presented at the 66th American Society of Hematology Annual Meeting & Exposition; December 7-10, 2024; San Diego, California.