(Lymphoma) Is Odronextamab Effective?
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- January 24, 2023
- Read time: 2 minutes
From December 10–13, 2022, Won-Seog Kim and colleagues from Samsung Medical Center presented results from the ELM-2 Phase 2 clinical trial evaluating the efficacy and safety of Odronextamab in previously treated relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients at the ASH 2022 Annual Meeting in New Orleans, Louisiana, USA.
The ELM-2 Phase 2 clinical trial was conducted jointly at multiple international facilities. Previously treated relapsed/refractory DLBCL patients received Odronextamab therapy (21-day treatment cycles: Cycle 1 Day 1: 0.2 mg, Day 2: 0.5 mg, Days 8–9: 2 mg each, Days 15–16: 10 mg each; Cycles 2–4 Days 1, 8, 15: 160 mg), then maintenance therapy at 320 mg on Day 1 every two-week cycle until intolerable adverse events occurred. The primary endpoint was objective response rate.
Patient characteristics: median age 67 years (range 24–88); 60% male; 80% classified as Stage III–IV per Ann Arbor classification; 58% with IPI score ≥3; median number of prior treatments was 2 (range 2–8).
At a median follow-up of 17.1 months, among 90 evaluable patients, the primary endpoint objective response rate was 53% (N=48/90), with complete response rate of 37% (N=33/90). The median complete response duration was not reached; the 9-month complete response rate was 73%.
Regarding safety, overall adverse event incidence was 84% (N=102). Adverse events confirmed in ≥30% of patients included cytokine release syndrome (CRS) 53%, fever 41%, and anemia 34%. Mild CRS rates were 35% and 13% respectively. Two patients experienced Grade 5 or higher adverse events, and eight patients discontinued treatment due to adverse events.
Based on the ELM-2 trial results, Won-Seog Kim and colleagues concluded: Odronextamab therapy demonstrated clinically meaningful antitumor activity in relapsed/refractory DLBCL patients with good patient tolerability to adverse events.
Source: https://ash.confex.com/ash/2022/webprogram/Paper158406.html
- Clinical Trial Medications
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