A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody, Versus Investigator's Choice in Previously Untreated Participants with Follicular Lymphoma (OLYMPIA-1)

Objective:

Part 1 (Safety Run-in)

Primary Objective:

• Assess the safety, tolerability, and dose-limiting toxicities (DLTs) of odronextamab in participants with previously untreated FL

Secondary Objectives:

• To characterize the pharmacokinetics (PK) of odronextamab
• To assess the immunogenicity of odronextamab
• To evaluate the preliminary anti-tumor activity of odronextamab

Part 2 (Randomized Phase)

Primary Objective:

• To compare the efficacy of odronextamab versus investigator’s choice chemotherapy in participants with previously untreated FL as measured by CR30 per independent central review

Secondary Objectives:

• To compare the efficacy per independent central review between odronextamab monotherapy and investigator’s choice chemotherapy as measured by:
  • PFS
  • Event-free survival (EFS)
• To compare the efficacy of odronextamab monotherapy versus investigator’s choice chemotherapy as measured by CR30 per investigator
• To evaluate the treatment effects on patient-reported physical function between odronextamab monotherapy and investigator’s choice chemotherapy utilizing EORTCQLQ-C30
• To compare the efficacy of odronextamab monotherapy versus investigator’s choice chemotherapy as measured by OS