CIRCULATING TUMOR DNA (CTDNA) STATUS AND CLINICAL OUTCOMES IN PATIENTS (PTS) WITH PREVIOUSLY UNTREATED DIFFUSE LARGE B‐CELL LYMPHOMA (DLBCL) IN THE POLARIX STUDY

Introduction: In the POLARIX study, pts with previously untreated DLBCL were randomized to Pola-R-CHP or R-CHOP (NCT03274492; Tilly et al., 2022). We validated prognostic value of ctDNA at baseline and after one cycle therapy in (Herrera 2022); here, we evaluate relationship between clearance PFS OS. Methods: Pts included if longitudinal results available. Plasma was measured baseline, Cycle (C) 5 Day (D) 1, end treatment (EOT), AVENIO NHL CAPP-Seq assay (Stokowski al. determined as described OS according status reported landmarked hazard ratios (HR) 3-yr rates. HRs adjusted for IPI score (>2), region, bulky disease (>7.5 cm), age (>60 years), cell origin. Results: At 654 had results; 494 (76%) 519 (79%) evaluable C5D1 EOT, respectively. Undetectable (ctDNA−) achieved by 57% (152/265) Pola-R-CHP-treated 59% (135/229) R-CHOP-treated (p = 0.79), 66% (172/262) 67% (172/257) EOT 0.83). Achieving ctDNA—was each arm (Table). who complete response (CR) PET-CT ctDNA—at superior compared CR detectable (ctDNA+) (PFS HR 0.30, 95% confidence interval [CI]: 0.14–0.66; 0.20, CI: 0.07–0.60). This not observed 0.74, 0.34–1.63; 1.11, 0.30–4.16). Among treated versus (HR 0.41, 0.21–0.82); this 0.14–1.18). There no statistically significant difference arms ctDNA+ 1.20, 0.49–2.83). Conclusions: longer survival. Although number arms, achieving arm, suggesting deeper molecular responses beyond detection sensitivity used analysis. Encore Abstract—previously submitted ASCO 2023 The research funded by: study (NCT03274492) sponsored F. Hoffmann-La Roche Ltd Genentech, Inc. Third-party editorial assistance, under direction authors, provided Carla Smith, MSc, Ashfield MedComms, an Inizio company, Ltd. Keywords: aggressive B-cell non-Hodgkin lymphoma, diagnostic biomarkers, minimal residual Conflicts interests pertinent abstract A. Herrera Consultant advisory role: Bristol-Myers Squibb, Seattle Genetics, Merck, Inc./F. Ltd, AstraZeneca/MedImmune, Karyopharm Therapeutics, ADC Takeda, Regeneron, Genmab, Tubulis GmbH, Pfizer, Adicet Bio, Caribou Biosciences, AbbVie Research funding: Kite (a Gilead company), AstraZeneca, Sciences, Therapeutics Educational grants: Squibb S. Tracy Employment leadership position: Stock ownership: L. H. Sehn Celgene, AbbVie, TG Janssen, Amgen, Ltd/Genentech, Inc., Lundbeck, Apobiologix, Company), Teva, therapeutics, Acerta Pharma, MorphoSys, Incyte, Debiopharm Group, Sandoz-Novartis, Verastem Honoraria: Janssen-Ortho, Verastem, Genmab Teva Jardin AbbVie/Genentech, G. Lenz Gilead, Novartis, Constellation, Karyopharm, Miltenyi, PentixaPharm, Sobi, Immagene, Genase, Hexal/Sandoz, Lilly Bayer, MorphoSys Other remuneration: Hexal/Sandoz (Speaker's Bureau). (Expert Testimony) M. Trněný Novartis Salles Epizyme, Velosbio, BeiGene, Miltenyi Biotec, Ipsen, Kite/Gilead, Loxo/Lilly, Molecular Partners, Nordic Nanovector, RAPT Incyte Owkin C. R. Flowers Spectrum Pharmaceuticals, Denovo Biopharma, Pharmacyclics/Janssen, Foresight Diagnostics, Squibb/Celgene, Curio Science, N Power Janssen Oncology, Pharmacyclics, Millennium, Alimera Xencor, 4D Adaptimmune, Cellectis, EMD Serono, Guardant Health, Iovance Biotherapeutics, Nektar, Sanofi, ZIOPHARM Oncology Celgene/Bristol-Myers J. P. Sharman Pharma/AstraZeneca, Merck Takeda Balasubramanian V. Raghavan Hirata Lee Y. Jiang Morschhauser Servier, Chugai, Eisai