Odronextamab plus chemotherapy in patients with previously untreated follicular lymphoma: First results from part 1 of the Phase 3 Olympia-2 study

作者：Kitsada Wudhikarn, Tuba Hacıbekiroğlu, José‐Ángel Hernández‐Rivas, Sebastian Grosicki, Jingxian Cai, Jingxiao Chen, Jurriaan Brouwer‐Visser, Julia Held, Aafia Chaudhry, Hesham Mohamed, Ashish Risal, Aránzazu Alonso Alonso · 发表于：Blood · 年份：2025 · DOI：10.1182/blood-2025-3600 · 被引用次数：2 · 研究领域：Lymphoma Diagnosis and Treatment、CAR-T cell therapy research、Chronic Lymphocytic Leukemia Research

Abstract Introduction Odronextamab (Odro), a CD20×CD3 bispecific antibody, showed promising efficacy as first-line monotherapy for patients (pts) with previously untreated follicular lymphoma (FL) in Part 1 of the ongoing Phase 3 OLYMPIA-1 study (NCT06091254). OLYMPIA-2 (NCT06097364), a Phase 3, randomized, open-label, multicenter study, is the first to assess whether Odro + chemotherapy (CHOP/CVP) induction ± Odro maintenance is superior to standard-of-care rituximab (R) + CHOP/CVP induction + R maintenance in pts with previously untreated FL (Part 2). The study comprises Part 1A (dose escalation) and Part 1B (dose optimization). Here, we report first results from Part 1A. Methods Part 1A included pts aged ≥18 years with previously untreated CD20+ Grade (Gr) 1–3a FL, Stage II bulky or Stage III/IV disease, a FLIPI-1 score of 3–5, and an ECOG performance status of ≤2. In Part 1A, Odro-CHOP/CVP was administered in 6 × 21-day induction cycles. Odro was administered intravenously with weekly step-up dosing (0.7/4/20 mg) starting on Cycle (C)1 Day (D)8, followed by full doses on C2 (D8 and 15), C3–4 (D1, 8, and 15), and C5D1, and 2 × full dose on C5D8 and C6 (D1 and 15). Odro full doses of 40 mg (dose level [DL]1) and 80 mg (DL2) were tested. Pts with a complete response (CR) or partial response after induction received ≤12 doses of Odro maintenance (320 mg once every 8 weeks). Part 1A primary endpoints were the incidence of dose-limiting toxicities (DLTs), and the incidence and ...