Ambati, Srikanth

Abstract Complete response (CR) is an important treatment goal in follicular lymphoma (FL). In relapsed or refractory (R/R) FL, CR rates decline, and disease progression accelerates with each treatment line, with particularly poor outcomes in patients with high‐risk features. Odronextamab, a CD20 × CD3 bispecific antibody, demonstrated deep, durable responses and generally manageable safety in R/R FL in the Phase 2 ELM‐2 study (NCT03888105); we present an exploratory analysis in patients who attained a CR. Patients received intravenous odronextamab with step‐up dosing in Cycle 1, 80 mg weekly in Cycles 2–4, then 160 mg once every 2 weeks until disease progression or other protocol‐defined reason for discontinuation. Patients with CR lasting ≥9 months switched to dosing once every 4 weeks. Overall, 73.4% (94/128) of patients attained CR, 93.6% (88/94) by first response assessment (~Week 12). Median time to CR was 2.7 months (range 2.3–7.9). Median duration of CR was 25.1 months (95% confidence interval [CI] 20.5–not evaluable [NE]) overall and 23.7 months (18.2–NE) in patients with high‐risk features. Overall, 79.5% (35/44) of patients who switched to Q4W dosing maintained CR at last assessment. Patients with low/undetectable CD20 expression by immunohistochemistry (<10% CD20 + cells) or RNA sequencing (messenger RNA < 500 transcripts per million) could achieve CR. Median progression‐free survival was 27.8 months (95% CI 23.0–NE) in patients with CR and not reached in those with undetectable circulating tumor DNA at Week 12. Treatment‐emergent adverse events (TEAEs) led to treatment discontinuation in 16.0% of patients with CR; the most common TEAE was cytokine release syndrome (56.4%). This generally manageable safety profile and the sustainability of CRs support odronextamab as a potential long‐term treatment for heavily pretreated R/R FL.

Abstract Introduction Elevated levels of fetal hemoglobin (HbF) ameliorate sickle cell disease (SCD) manifestations. BEAM-101 is an investigational cell therapy comprising ex vivo base-edited autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) that directly target the HBG1/2 promoters to disrupt BCL11A binding, switching production from sickle (HbS) to majority anti-sickling HbF. We present ongoing data from the BEACON study (NCT05456880), a Phase 1/2, single-arm, open-label study evaluating a single dose of BEAM-101 in individuals with SCD and severe vaso-occlusive crises (sVOCs). Methods Eligible patients were aged 12–35 years with SCD and ≥4 sVOCs in the 2-year period prior to informed consent. After mobilization with weight-based or tiered fixed-dose plerixafor, autologous CD34+ HSPCs were collected by leukapheresis and genetically modified with an adenine base editor. Following conditioning with pharmacokinetically adjusted myeloablative busulfan (target cumulative AUC 80 hr*mg/L), patients received a single dose of BEAM-101 (≥3.0×106 viable CD34+ cells/kg). Patients were then monitored for neutrophil and platelet engraftment, adverse events (AEs), total Hb, Hb fractions, % F-cells, hemolysis markers, sVOCs, and additional protocol endpoints for up to 24 months. Results As of June 16, 2025, enrollment has been completed and 46 patients have initiated mobilization. Of the 26 patients who have received BEAM-101, mean duration of follow-up was 6.2 (range 1.0–18.7) months. Baseline demographics were: age 18–34 years, 24 βS/βS genotype, 21 self-reported Black/African American, and 11 female. One patient, who successfully engrafted and obtained stable HbF levels &gt;60%, withdrew consent 5 months post-infusion. For the 26 treated patients, the median number of stem cell collection cycles was 1 (range 1–4); 18 (69.2%) required a single cycle, 4 required 2 cycles, and 4 required &gt;2 cycles. Target cell dose was achieved with a median of 3 (1–12) collection days. Patients received a mean BEAM-101 dose of 8.4 (range 3.2–23.4) ×106 viable CD34+ cells/kg. By the data cut, patients achieved neutrophil (n=26) and platelet (n=24) engraftment at a median of 18 (12–30) days and 19 (11–50) days, respectively, with a median duration of 7 (4–17) days of neutropenia. Of the 24 evaluable patients, 9 (37.5%) achieved platelet engraftment without requiring platelet transfusion through the transplant process. No patients had ≥Grade 3 AEs or serious AEs related to BEAM-101. One patient died due to respiratory failure, assessed as likely related to busulfan conditioning, 4 months post-infusion as previously reported. Mean total Hb increased to 12.1 (range 9.0–14.7) g/dL by Month (M) 1 (n=24), 15.6 (11.9–18.6) g/dL by M6 (n=11), and was sustained through follow-up. Four patients had total Hb levels above the normal range beyond M6 without any associated clinical manifestations or need for therapeutic intervention. Erythropoietin levels trended towards normal in all patients, including those with elevated total Hb. Mean endogenous HbF (HbF/[HbF+HbS]) was &gt;60% and HbS was &lt;40% by M1, which was sustained through last follow-up. At M6, mean % F-cells were 99.2% (97.0–99.9; n=10) and mean HbF/F-cell was 20.8 (18.0–23.9; n=9) pg, exceeding the protective threshold of 10 pg against sickling. Peripheral blood editing was at a mean of 68.5% by M3 (n=16), 69.6% by M6 (n=10), and 72.8% by M12 (n=5). Hemolysis markers and sickling parameters normalized or improved for all patients. No patients experienced any investigator-reported sVOCs post-engraftment. Conclusions The BEAM-101 treatment process is characterized by a low number of mobilization and collection cycles and high editing efficiency, resulting in rapid neutrophil and platelet engraftment and robust pancellular HbF expression, with durability observed up to 18 months. Additionally, there is a corresponding reduction in HbS levels to &lt;40%, and improvements or resolution of hemolysis parameters and anemia, along with resolution of investigator-reported sVOCs post-engraftment. The safety profile of the BEAM-101 treatment regimen is consistent with busulfan conditioning, autologous HSCT, and underlying SCD. These results demonstrate the potential for base editing of the HBG1/2 promoters as a safe and effective therapeutic modality for the treatment of SCD that also has the potential to minimize hospitalization and treatment process burden for patients, families, and sites.

7049 Background: Odronextamab, an investigational off-the-shelf CD20×CD3 bispecific antibody, demonstrated compelling efficacy and a generally manageable safety profile in heavily pretreated pts with R/R FL in the primary analysis of the Phase 2 ELM-2 study (NCT03888105; Kim TM, et al. Ann Oncol 2024). We present updated efficacy and safety data for odronextamab in pts with R/R FL from ELM-2 after >2 yrs follow-up. Methods: Odronextamab was administered intravenously until disease progression/unacceptable toxicity, with Cycle (C) 1 step-up dosing to help mitigate cytokine release syndrome (CRS) risk, as reported previously. Pts with a complete response (CR) for ≥9 months (mo) switched from maintenance dosing Q2W to Q4W. Primary endpoint: objective response rate (ORR) per Lugano criteria by independent central review (ICR); secondary endpoints: CR rate, duration of response (DOR), progression-free survival (PFS), overall survival (OS). Results: At the updated data cutoff (Aug 15, 2024), 157 pts with centrally confirmed R/R FL Grade (Gr) 1–3a were enrolled. Median no. of treatment cycles: 19.0 (range 0.1–117.3); 96.2% (n = 151) and 82.8% (n = 130) of pts completed C1 and C4, respectively. The global cohort comprised 128 pts evaluable for efficacy. At a median efficacy follow-up of 28.3 mo, ORR was 80.5% (n = 103) by ICR and CR rate was 74.2% (n = 95); 92.2% of responders achieved CR. Responses were durable (median DOR, 26.0 mo; median duration of CR, 32.2 mo). ORR was consistent across high-risk subgroups (Follicular Lymphoma International Prognostic Index score 3–5, 78.4%; progression of disease within 2 yrs of frontline therapy, 81.0%). Median PFS was 23.0 mo (estimated 36-mo PFS rate, 37.5%), and median OS was 54.2 mo (estimated 36-mo OS rate, 62.6%). Median PFS was longer in pts who were minimal residual disease (MRD) negative (42.4 mo) versus MRD positive (21.6 mo) at Week 12. Of 47/128 pts who switched to Q4W dosing, 32 remained in CR. The odronextamab long-term safety profile was consistent with the primary analysis. All 157 pts had TEAEs (Gr ≥3, 86.0%), and 15.3% discontinued treatment due to TEAEs (most common: COVID-19 infection, 2.5%). With 0.7/4/20 mg step-up dosing (n = 89), CRS events were mostly low grade (Gr 1, 46.1%; Gr 2, 13.5%; Gr 3, n = 1; Gr ≥4, n = 0), occurred mostly in C1, and resolved in a median of 8.4 hrs. Immune effector cell-associated neurotoxicity syndrome was reported in one pt (Gr 2). Infections were reported in 79.0% of pts (124/157; Gr ≥3, 42.0%). COVID-19-related infections were reported in 38.2% of pts (Gr 5, 5.7%). Conclusions: With longer follow-up, odronextamab demonstrated durable responses in heavily pretreated pts with R/R FL from ELM-2, with robust efficacy in those with high-risk features, and a generally manageable safety profile. Overall, these compelling results support odronextamab as a potential off-the-shelf treatment option for pts with R/R FL. Clinical trial information: NCT03888105 .

Abstract Patients with relapsed/refractory diffuse large B-cell lymphoma progressing after chimeric antigen receptor T-cell (CAR-T) therapy have dismal outcomes. The prespecified post–CAR-T expansion cohort of the ELM-1 study investigated the efficacy and safety of odronextamab, a CD20×CD3 bispecific antibody, in patients with disease progression after CAR-Ts. Sixty patients received IV odronextamab weekly for 4 cycles followed by maintenance until progression. The primary end point was objective response rate (ORR) by independent central review. The median number of prior lines of therapy was 3 (range, 2-9), 71.7% were refractory to CAR-Ts, and 48.3% relapsed within 90 days of CAR-T therapy. After a median follow-up of 16.2 months, ORR and complete response (CR) rate were 48.3% and 31.7%, respectively. Responses were similar across prior CAR-T products and time to relapse on CAR-T therapy. Median duration of response was 14.8 months and median duration of CR was not reached. Median progression-free survival and overall survival were 4.8 and 10.2 months, respectively. The most common treatment-emergent adverse event was cytokine release syndrome (48.3%; no grade ≥3 events). No cases of immune effector cell–associated neurotoxicity syndrome were reported. Grade ≥3 infections occurred in 12 patients (20.0%), 2 of which were COVID-19. Odronextamab monotherapy demonstrated encouraging efficacy and generally manageable safety, supporting its potential as an off-the-shelf option for patients after CAR-T therapy. This trial was registered at www.clinicaltrials.gov as #NCT02290951.

Introduction Patients (pts) with relapsed/refractory (R/R) follicular lymphoma (FL) experience progressively worse outcomes with each successive line of therapy; complete response (CR) rates are 44% with third-line (3L), 27% with 4L, and 22% with 5L+ therapies (Ghione P et al. Haematologica 2023). CR duration is particularly important considering the rapid disease progression observed with 3L+ therapies in pts with FL, with especially poor outcomes in those with high-risk features (Liu J et al. Front Oncol 2023; Philips T et al. ASH 2023). In ELM-2 (NCT03888105), odronextamab (an investigational CD20×CD3 bispecific antibody) demonstrated deep and durable responses and generally manageable safety in pts with R/R FL who had received ≥2 prior lines of systemic therapy. Median progression-free survival (PFS) and overall survival (OS) in pts with CR were 28 months (95% CI 23.0-not evaluable [NE]) and not reached (95% CI 40.4-NE), respectively. Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 86% of pts (Taszner M et al. EHA 2024). For the current analysis, we present details on the efficacy and safety of 3L+ odronextamab treatment in pts with R/R FL who attained CR in ELM-2, including those with high-risk features. Methods ELM-2 is an ongoing, open-label, multicenter, Phase 2 trial of odronextamab in pts with R/R B-cell non-Hodgkin lymphoma, including a cohort with FL Grade 1-3a. Intravenous odronextamab was administered in step-up doses with steroid prophylaxis during Cycle (C) 1, followed by 80 mg on Days 1, 8, and 15 of C2-4. After C4, dosing continued at 160 mg once every 2 weeks (Q2W); pts switched to Q4W dosing if they had a durable CR for ≥9 months. The primary endpoint was objective response rate (ORR) according to Lugano classification, by independent central review (ICR). Secondary endpoints included CR rate, PFS, OS, duration of response, and safety. Results Primary results in pts evaluable for efficacy and safety (N=128) using the Oct 20, 2023, data cutoff have been reported. Median duration of efficacy follow-up was 20.1 months (95% CI 17.3-27.8). The ORR was 80.5% (103/128 pts; 95% CI 72.5-86.9), and CR rate was 73.4% (94/128; 95% CI 64.9-80.9). Median duration of CR (DOCR) was 25.1 months (95% CI 20.5-NE), and median time to CR was 2.7 months (range 2.3-7.9). Baseline characteristics of pts with CR (n=94) were similar to those of the overall population, and median duration of treatment exposure was 13.8 months (range 1.8-45.0). In total, 88 pts (93.6%) had CR at the first response assessment (~Week 12) and 6 (6.4%) reached CR later, including 3 pts who had stable disease initially. Twenty-eight pts (29.8%) were still receiving treatment at data cutoff, and 66 (70.2%) had discontinued treatment. Of those who discontinued, 42 still had CR at the last response assessment. Primary reasons for treatment discontinuation were disease progression (n=17), TEAEs (n=16 [including 6 pts with COVID-19]), physician decision (n=12), withdrawal by subject (n=11), and death (n=8). All 8 deaths resulted from TEAEs, including COVID-19 in 5 pts. Eighty-five pts (90.4%) with CR had high-risk features (POD24, 48.9%; FLIPI score 3-5, 55.3%; refractory to last treatment, 70.2%); median DOCR and median time to CR in these pts were similar to those in all pts (23.7 months [95% CI 18.2-NE] and 2.7 months [range 2.3-7.9], respectively). At the time of the current analysis, 44 pts with CR by ICR (46.8%) had switched to Q4W dosing, with a median duration of exposure of 17.7 months (range 13.1-45.0). Among these pts, 22 had discontinued treatment at data cutoff due to adverse events (n=7 [including 1 with COVID-19]), physician decision (n=6), death (n=3), withdrawal by subject (n=3), progressive disease (n=2), and an “other” reason (n=1). Conclusions Pts with R/R FL and CR to 3L+ odronextamab treatment in ELM-2 had a median DOCR of 25.1 months that was prolonged beyond the median duration of treatment exposure (13.8 months). Almost half (46.8%) of pts proceeded to monthly odronextamab administration, with a median duration of treatment exposure of 17.7 months. These data show the sustainability of CR in pts with FL treated with 3L+ odronextamab, including in those with high-risk features. The safety profile of odronextamab was generally manageable in the overall population, including in pts with CR, despite their prolonged drug exposure. These findings support the potential of odronextamab as a treatment for R/R FL.

Introduction CD19-directed CAR T-cell therapies are an important option for the management of relapsed/refractory (R/R) DLBCL. Studies suggest that ~50% of pts receiving CAR T-cell therapies will relapse within 6 months, with an estimated overall survival (OS) of only 5 months. Additionally, 25-35% of pts do not receive subsequent treatment, indicating a high unmet need. CD19 loss is a potential mechanism of resistance to CAR T-cell therapies; thus, treatments that target alternate B-cell antigens are an attractive option. Here, we report for the first time the primary analysis of the ELM-1 expansion cohort investigating the efficacy and safety of odronextamab, a CD20×CD3 bispecific antibody, in pts with R/R DLBCL progressing after CAR T-cell therapy (NCT02290951). Methods Pts aged ≥18 with DLBCL and disease progression after CAR T-cell therapy received intravenous odronextamab weekly in 21-day (D) cycles during Cycles (C) 1-4, with steroid prophylaxis and step-up dosing in C1 (described previously), followed by 160 mg on D 1, 8, and 15 of C2-4. After C4, odronextamab maintenance treatment continued at 320 mg Q2W until disease progression or unacceptable toxicity. Pts with complete response (CR) for ≥9 months transitioned to Q4W dosing. All pts received infection prophylaxis. The primary analysis was conducted when all pts had completed ≥9 months of follow-up. Primary endpoint was objective response rate (ORR), as assessed by independent central review (ICR) according to the Lugano classification. Key secondary endpoints included duration of response (DOR), progression-free survival (PFS), and OS. Exploratory endpoints included immune biomarker assessment. Results As of January 22, 2024, 60 pts were treated and evaluable for efficacy and safety, with median follow-up of 16.2 months. Prior CAR T-cell therapies were axi-cel (50%), tisa-cel (12%), liso-cel (10%), and not specified (28%). Median time since prior CAR T-cell therapy was 6.5 months (range 1.2-46.2). Median age was 63 years (range 27-82; aged ≥75 years: 10%), and 65% were male. Pts had received a median of 3 prior lines of therapies (range 2-9); 77% of pts were refractory to their last therapy, 77% were double refractory, and 72% were refractory to prior CAR T-cell therapy. 48% of pts relapsed within 90 D of CAR T-cell therapy, and 67% relapsed within 180 D. Of the 20 pts with available tumor biopsies at baseline, 10 were CD19(-) and only 2 were CD20(-). 92% of pts completed C1 and 52% completed ≥4 C of treatment. The median duration of treatment was 12 weeks (range 0.7-154.1). The ORR and CR rate by ICR were 48% and 32%, respectively, and were consistent across pts with high-risk features and across prior CAR T products. ORR in pts relapsing in ≤90 D was 21% (6/29) and in pts relapsing in ≤180 D was 33% (13/40). ORR was observed even in pts with low CD20. Median DOR was 14.8 months (95% CI 2.8-not estimable [NE]) and median duration of CR was not reached (NR) (95% CI 3.3-NE); the probability of maintaining CR for 24 months was 68%. Median PFS was 4.8 months (95% CI 2.6-5.4) and median OS was 10.2 months (95% CI 4.6-15.8). Median PFS and OS in complete responders was NR. T-cell counts increased at Week 14 and demonstrated a functional phenotype (CD69 expression and TEMRA count), which was confirmed by ex vivo stimulation. T-cell expansion was observed regardless of CAR T product or time from CAR T administration. The most common TEAE was CRS (any grade [G]: 48%; G1: 25%; G2: 23%; G≥3: 0%). G≥3 TEAEs occurred in 77% of pts (most common: neutropenia 17%, anemia 13%, and neutrophil and white blood cell count decrease 10% each). Five pts (8%) permanently discontinued odronextamab due to AEs (COVID-19, pneumonia, encephalopathy, epilepsy, and gait disturbance [n=1 each]). There was one treatment-related death (COVID-19 pneumonia). No cases of ICANS were reported. G≥3 infections occurred in 12 pts (20%); 2 were due to COVID-19. No cases of tumor flare or TLS were reported. Conclusions ELM-1 is the only study to prospectively evaluate efficacy and safety of a CD20×CD3 bispecific antibody in pts with R/R DLBCL progressing after CAR T-cell therapy. Odronextamab monotherapy was associated with encouraging efficacy and generally manageable safety in a setting with limited treatment options and historically dismal outcomes. Efficacy was observed even in pts relapsing in ≤90 D, supporting the potential of odronextamab as an accessible, off-the-shelf option in the post-CAR T setting.

Introduction In ELM-2 (NCT03888105), a Phase 2, open-label, multicohort study, odronextamab monotherapy demonstrated encouraging clinical efficacy, generally manageable safety, and maintenance of patient-reported outcomes in R/R FL (Chong et al. AACR 2024; Tessoulin et al. ASH 2023). In the absence of head-to-head clinical trials comparing CD20×CD3 bispecific antibodies in R/R FL, two unanchored MAICs were conducted to evaluate the efficacy of odronextamab versus mosunetuzumab and epcoritamab in patients with R/R FL in the third-line or later (3L+) setting. Methods Patient-level data from the ELM-2 R/R FL cohort receiving odronextamab (N=128; data cutoff: October 2023) were compared with published data from similar cohorts in the GO29781 trial of mosunetuzumab (N=90; Budde et al. Lancet Oncol 2022) and EPCORE NHL-1 trial of epcoritamab (N=128; Linton et al. Lancet Haematol 2024). To adjust for baseline differences in the trial populations, a priori-identified prognostic variables (progression of disease within 2 years, primary refractory, refractory to last line of therapy [LOT], number of prior LOTs, serum lactate dehydrogenase level, Eastern Cooperative Oncology Group performance status, Follicular Lymphoma International Prognostic Index, age at start of LOT, and Ann Arbor disease stage) were included in the base-case MAICs. Two additional variables (double refractory and prior autologous stem cell transplant), reported in ELM-2 and the comparator studies, were included in a sensitivity analysis. The MAICs reported here were focused on response outcomes as assessed by independent central review, which were reported across trials. Relative treatment effects before and after matching were presented as odds ratios (ORs), along with 95% confidence intervals (CIs). Results The effective sample size for odronextamab was 102.0 after matching with mosunetuzumab and 90.6 after matching with epcoritamab in the base-case MAICs. All key prognostic variables were balanced between ELM-2 and both comparator trials in each analysis. Before and after matching, odronextamab demonstrated comparable objective response rates (ORRs) and significantly higher complete response (CR) rates versus mosunetuzumab (before matching: ORR 80.5% vs 80.0%, OR 1.03 [95% CI 0.52-2.03], p=0.93; CR rate 73.4% vs 60.0%, OR 1.84 [95% CI 1.04-3.28], p=0.04; after matching: ORR 83.5% vs 80.0%, OR 1.27 [95% CI 0.61-2.65], p=0.53; CR rate 75.7% vs 60.0%, OR 2.08 [95% CI 1.12-3.86], p=0.02). Odronextamab demonstrated numerically higher CR rates versus epcoritamab before and after matching (before matching: CR rate 73.4% vs 62.5%, OR 1.66 [95% CI 0.98-2.82], p=0.06; after matching: CR rate 69.4% vs 62.5%, OR 1.36 [95% CI 0.77-2.41], p=0.29). The ORRs of odronextamab and epcoritamab were comparable before matching (ORR 80.5% vs 82.0%, OR 0.90 [95% CI 0.48-1.69], p=0.75) and after matching (ORR 78.1% vs 82.0%, OR 0.78 [95% CI 0.40-1.53], p=0.47). Consistent results were observed in the sensitivity analyses. Conclusions In the absence of head-to-head clinical trials comparing bispecific antibodies in the setting of 3L+ FL, MAICs demonstrate that odronextamab was associated with higher CR rates compared with mosunetuzumab and epcoritamab. Since achieving a CR in the R/R FL setting is an important treatment goal, our results highlight the potential of odronextamab as an effective treatment option in R/R FL.

e19057 Background: In ELM-2 (NCT03888105), a Ph 2, single arm, open label trial, odronextamab demonstrated robust efficacy, generally manageable safety, and overall maintenance of patient-reported outcomes (PROs) in R/R FL pts (Villasboas et al. ASH 2023). In FL, pts with disease progression within 2 yrs of frontline chemoimmunotherapy (POD24) are hard to treat with poor clinical outcomes, representing an unmet need. We report PROs by POD24 status in pts with Grade 1–3a R/R FL from ELM-2. Methods: Pts received IV odronextamab in 21-day cycles (C): 80 mg QW in C1–4, with C1 dose step up to mitigate cytokine release syndrome, then 160 mg Q2W (Q4W if complete response ≥9 mo) until progression. PROs were collected at baseline (BL), Wks 2–4, 10, then Q8W in Yr 1, and Q12W in Yr 2. Post-hoc POD24 subgroup analyses were performed on six EORTC QLQ-C30 scales, the EQ-5D-3L VAS, and FACT-Lym LymS. Estimated mean change from BL (CFB) was analyzed using mixed models for repeated measures (MMRM) through Wk 42 (≥10 pts at last assessment). Published meaningful CFB thresholds were used to define deterioration/improvement in responder analyses. Results: By Jan 31, 2023, 140 pts with R/R FL had received odronextamab. Pts with POD24 (n=70) were younger than pts without POD24 (n=70; median age 57.5 vs 62.0 y), had fewer prior Tx lines (median 2 vs 3), and a higher proportion double refractory to anti-CD20 Ab + alkylator (53% vs 29%). Objective response rate was similar in evaluable pts with (n=63; 79%) and without (n=65; 80%) POD24. PRO questionnaire completion ranged from 52–95% through Wk 42 across groups. Descriptive analyses suggest BL PRO scores were similar by POD24 status, showing good HRQoL/functioning and low symptom burden, and were generally maintained through Wk 42 with minimal between-group differences (overlapping 95% CIs for LS mean CFB [Table]). In both groups, more pts reported PRO maintenance or improvement vs deterioration across visits, except for fatigue at Wk 10 in pts without POD24. Conclusions: In pts with heavily pretreated R/R FL, odronextamab Tx maintained HRQoL, functioning, and symptoms irrespective of POD24 status. Clinical trial information: NCT03888105 . [Table: see text]