Authors: Leslie A. Lori, Lorenzo Falchi, Joost S.P. Vermaat, Gerardo Musuraca, David Belada, Marcel Nijland, Jacob Haaber Christensen, Fritz Offner, Daniela Hoehn, Jennifer Marek, Liwei Wang, JP Mei, Pau Abrisqueta, Joshua D. Brody
Published: 2024-06-28
DOI: 10.1200/jco.2024.42.16_suppl.7014
Source: Full article
7014 Background: In 1L FL, more effective, less toxic treatment (tx) options that induce durable complete responses (CRs) are needed. For responders, novel maintenance approaches are needed to improve long-term outcomes. We present data from EPCORE™ NHL-2 (phase 1/2; NCT04663347), with longer follow-up for epcoritamab + R2 in 1L FL (arm 6) and the first disclosure for epcoritamab maintenance in patients (pts) with FL in CR or partial response (PR) after 1–2 lines of standard of care (SOC) tx (arm 7). Methods: Adults with CD20+ FL grade (G) 1–3A received subcutaneous epcoritamab 48 mg. In arm 6, pts received R2 for ≤12 cycles (Cs) of 28 d and epcoritamab (QW, C1–2; Q4W, C3–26). In arm 7, pts received epcoritamab (QW, C1 [28 d]; Q8W, C2–13 [56 d/C]). Pts received step-up epcoritamab dosing and corticosteroid prophylaxis in C1 to mitigate CRS. Primary endpoints were overall response rate (ORR; Lugano criteria) in arm 6 and safety/tolerability in arm 7. Results: As of Nov 22, 2023, 41 pts with 1L FL received epcoritamab + R2 (arm 6) and 20 pts in CR or PR after SOC tx received epcoritamab maintenance (arm 7). In arm 6 (median follow-up, 21.1 mo), median age was 57 y and 34% had FLIPI 3– 5. ORR was 95%; CR rate was 85%. The most common treatment-emergent AEs (TEAEs) were COVID-19 (63%), CRS (56%), and neutropenia (56%). CRS was low grade (41% G1, 15% G2) and resolved; most events occurred after the first full dose and none led to epcoritamab discontinuation. Two fatal TEAEs occurred (COVID-19 pneumonia and septic shock). In arm 7 (median follow-up, 19.7 mo), median age was 54.5 y and 25% had FLIPI 3–5; 60% had CR and 40% had PR with their last tx line. All pts had prior anti-CD20 tx, 80% had prior alkylating agents, and 50% had prior anthracyclines; 80% had 1 prior tx line. The most common TEAEs were COVID-19 (70%) and CRS (55%). CRS was G1 (40%) or G2 (15%) and resolved; events mostly occurred after the first full dose, and none led to tx discontinuation. One fatal TEAE occurred (respiratory failure; post-acute COVID syndrome after 2 Cs of tx). No ICANS or clinical tumor lysis syndrome occurred in either arm. Additional efficacy data are in Table. Conclusions: In arm 6, epcoritamab + R2 continued to show deep, durable responses in 1L FL; safety was manageable and consistent with prior reports. In arm 7, the first epcoritamab maintenance data in FL showed conversions from PR to CR, with manageable safety and no new safety signals. The data warrant further evaluation of epcoritamab-based, chemotherapy-free regimens in FL. Clinical trial information: NCT04663347 . [Table: see text]