Background: Atezolizumab plus bevacizumab (atezo+bev) is a standard-of-care 1L treatment for unresectable hepatocellular carcinoma (uHCC). Understanding its adoption and use, clinical outcomes, and subsequent therapies are needed. Methods: This retrospective cohort study included 550 patients with uHCC in the US who initiated 1L atezo+bev between June 2020 and April 2023. Medical records were abstracted to describe treatment patterns and outcomes. Results: Of 294 patients who discontinued 1L therapy, 176 patients initiated 2L therapy (2L cohort) and 48 patients didn't initiate 2L therapy after >= 8 weeks of follow-up (No 2L cohort). More of the No 2L cohort had Stage IVb tumors, BCLC stage D, ECOG-PS >= 2, ascites, and hepatic encephalopathy at baseline. The 2L cohort were more likely to discontinue atezo+bev due to disease progression (92.1% vs. 56.3%), and less likely due to toxicity/intolerability (4.0% vs. 10.4%) than the No 2L cohort. OS from 1L atezo+bev initiation was significantly longer in the 2L cohort vs. No 2L cohort (median 23.0 vs. 14.3 months; p < 0.001]). Conclusions: 1L Atezo+bev was clinically active with 256 patients remaining on therapy at last follow-up. Patients who progressed after 1L atezo+bev benefited from additional systemic therapies. Future research analyzing the comparative effectiveness of 2L therapies is needed.

AIMS:To describe United States real-world oral mucositis/stomatitis (OM/S) management for patients with non-small cell lung cancer (NSCLC) or breast cancer (BC) and document physician awareness of OM/S guidelines, risk factors, and barriers to care. PATIENTS & METHODS:This study included a cross-sectional physician survey and retrospective chart review. Physicians completed an electronic survey and abstracted chart data for patients with advanced/metastatic NSCLC or BC who developed treatment-related OM/S on or after 1 January 2021. RESULTS:Thirty-one physicians abstracted data for 272 patients (146 NSCLC; 126 BC). Median patient age at OM/S event was 66.2 years (NSCLC) and 61.6 years (BC). Systemic treatments included chemotherapy (NSCLC: 86.3%; BC: 67.5%), immunotherapy (NSCLC: 56.8%; BC: 10.3%), and targeted therapy (NSCLC: 9.6%; BC: 46.8%). OM/S-related treatment changes (reduction/interruption/discontinuation) were reported in 20.5% and 35.7% of patients with NSCLC or BC, respectively. A majority of physicians (61.3%) were unaware of published OM/S management guidelines. Physicians identified poor oral hygiene (80.6%) and limited physician awareness of OM/S guidelines (71.0%) as barriers to OM/S management. CONCLUSIONS:OM/S occurs across cancer treatment regimens and can lead to treatment modification. Improvements in OM/S management at the patient and provider level are needed to enhance care and improve clinical outcomes.

ABSTRACT Background Tafasitamab, a CD19‐targeting immunotherapy, is approved in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B‐cell lymphoma (R/R DLBCL) ineligible for autologous stem cell transplant. This real‐world study describes patient characteristics, treatment patterns, and outcomes associated with tafasitamab for R/R DLBCL across US practice settings. Methods A retrospective physician‐abstracted chart review was conducted among US adults initiating tafasitamab (with/without lenalidomide) for R/R DLBCL as part of routine clinical care. Data were summarized using descriptive statistics. Cox proportional hazards‐based analyses were performed to determine baseline characteristics associated with real‐world progression‐free survival and overall survival. Results Twenty‐three physicians (83% community physicians) provided data on 181 patients (64% White; median follow‐up since initiation, 14.7 months) meeting eligibility criteria. Most patients (72%) received tafasitamab as second‐line (2L) therapy. Real‐world overall response rate (95% CI) to tafasitamab was 73.5% (67.0–79.9). Median (95% CI) real‐world progression‐free survival and overall survival from tafasitamab initiation were 11.3 (9.8–13.6) and 24.8 (17.8–NE) months, respectively. In multivariable Cox proportional hazards‐based analyses, tafasitamab use in third‐line to fifth‐line (3L–5L) (vs. 2L), bulky disease (vs. non‐bulky), Ann Arbor Stage III–IV (vs. stage I–II), and increasing Charlson Comorbidity Index scores were determined as factors associated with increased progression risk. In addition, increasing age, tafasitamab in 3L–5L (vs. 2L), bulky disease (vs. non‐bulky), and Eastern Cooperative Oncology Group performance status (ECOG PS) ≥ 2 (vs. < 2) were associated with higher mortality risk. Conclusion This analysis of a diverse US population who received tafasitamab for R/R DLBCL predominantly in community practice settings supports the clinical benefit of tafasitamab. Trial Registration The authors have confirmed clinical trial registration is not needed for this submission.

INTRODUCTION:Nearly half of patients with prostate cancer experience biochemical recurrence (BCR) within 10 years after definitive treatment. Among them, patients with high-risk BCR are those who have a prostate-specific antigen (PSA) doubling time (PSADT) of ≤ 9 months, which is one of the strongest predictors of poor outcomes. This study aimed to define characteristics and treatment patterns among patients whose PSADT was documented or undocumented by treating physicians at the time of high-risk BCR diagnosis. PATIENTS AND METHODS:Participating physicians from the United States Cardinal Health Oncology Provider Extended Network abstracted medical record data of patients with high-risk BCR into electronic case report forms (index: 2018-2020; follow-up through 2022). Physicians reported PSADT values at index using labs, clinical judgment, or online calculation. If not provided, PSADT was retrospectively calculated using PSA data from the case report forms. Baseline characteristics and treatment patterns were compared between patients with documented versus undocumented PSADT. RESULTS:Among 284 patients, PSADT was not documented by treating physicians in 180 patients (63%) at the time of high-risk BCR diagnosis. For the 104 patients (37%) for whom PSADT was documented, physicians often overestimated PSADT compared with retrospective calculations based on validated tools, underestimating progression risk. Notably, patients with documented PSADT had a significantly shorter median time to treatment than those with undocumented PSADT (1.0 vs. 6.7 months; hazard ratio: 3.4; 95% confidence interval: 2.6-4.4; P < .0001). CONCLUSION:Many patients with high-risk BCR may be unidentified in practice despite widespread availability of PSADT calculators to characterize risk. Physicians that document PSADT are more likely to prescribe treatment early, despite underestimating progression risk (ie, overestimating PSADT). Efforts should be made to improve consistent, accurate PSADT calculation and documentation by physicians to inform treatment decision-making for management of high-risk BCR.

Real-world data on treatment response after switching between thrombopoietin receptor agonists are limited for patients with immune thrombocytopenia (ITP). The objective of this study is to describe treatment patterns and outcomes in patients with primary ITP who switched from eltrombopag (ELT) or romiplostim (ROMI) to avatrombopag (AVA). We conducted a retrospective chart review study of adults with primary ITP who initiated ELT or ROMI on or after 1 July 2019, switched to AVA within 30 days of ELT/ROMI discontinuation and had ≥6 months follow-up after AVA initiation. Patients were followed from AVA initiation until last contact, death or study end (21 March 2025), whichever occurred earliest. Response was defined as achieving ≥1 platelet count (PC) of ≥30 × 109/L, ≥50 × 109/L or ≥100 × 109/L in the absence of rescue therapy. Response durability was the percentage of time on AVA with PCs above the response threshold among responders. Patients (N = 201) most commonly discontinued ELT/ROMI due to lack of efficacy (59.2%). Among patients with baseline PCs <30 × 109/L (n = 79), 98.7% and 94.9% achieved PCs ≥30 × 109/L and ≥50 × 109/L on AVA respectively. Median response durability was 93.8%, 89.6% and 67.4% for ≥30 × 109/L, ≥50 × 109/L and ≥100 × 109/L respectively. Most patients who switched to AVA from ELT or ROMI achieved or maintained a clinically meaningful and durable platelet response throughout the study period.

Background Avatrombopag (AVA) is a thrombopoietin receptor agonist (TPO-RA) approved for patients with immune thrombocytopenia (ITP), but real-world data is limited in TPO-RA-naïve patients. Objectives To describe treatment patterns and outcomes in TPO-RA-naïve adult patients with primary ITP treated with AVA. Methods This retrospective chart review study included TPO-RA-naïve adults with primary ITP who initiated AVA on or after July 1, 2019, with ≥ 6 months of follow-up. Patients were followed from AVA initiation until the earliest of either last contact, death, or study end (January 20, 2025). Response was defined as achieving a platelet count (PC) ≥ 30, ≥ 50, or ≥ 100 × 109/L at least once. Response durability was calculated as the percentage of time on AVA with PCs above a response threshold among responders. PCs during or directly after rescue therapy were excluded from response assessments. Results Among 200 patients, 84.0% initiated AVA with baseline PCs < 30 × 109/L. Of these, 98.8% achieved PCs ≥ 30 × 109/L, 94.0% achieved PCs ≥ 50 × 109/L, and 74.4% achieved PCs ≥ 100 × 109/L. Median response durability was 93.2% for ≥ 30 × 109/L, 88.3% for ≥ 50 × 109/L, and 70.2% for ≥ 100 × 109/L. Most patients (66.5%) remained on their initial AVA dose. Median follow-up and treatment duration were 8.5 months (IQR, 7.0-13.5) and 8.0 months (IQR, 6.4-10.9), respectively. At last follow-up, 74.5% of patients remained on AVA. Discontinuation reasons included target PC achievement (51.0%), death (7.8%), and adverse events (2.0%). Most living patients who discontinued AVA (59.6%) received no further ITP treatment. Conclusion AVA is an effective treatment option for TPO-RA-naïve patients with ITP, demonstrating a high real-world rate of sustained PC response.

Abstract Potential CD19 antigen loss following CD19-directed therapy has raised concerns over sequential use of these therapies. Tafasitamab, a CD19-targeting immunotherapy, combined with lenalidomide, is approved for relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) treatment in adults ineligible for autologous stem cell transplantation. This retrospective analysis examined characteristics and outcomes of adults with R/R DLBCL who received tafasitamab preceding CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy in a real-world setting. Nine patients received tafasitamab and lenalidomide immediately preceding CAR-T. Median (first quartile [Q1]–third quartile [Q3]) follow-up time since tafasitamab initiation was 26.1 (18.0–28.0) and after CAR-T was 9.3 (1.9–16.7) months. Of the 9 patients, 4 had complete response, 4 had partial response, and 1 had stable disease following tafasitamab; all discontinued tafasitamab due to disease progression. Median (Q1–Q3) tafasitamab therapy duration was 11.0 (8.1–14.1) months. Three patients had CD19 testing following tafasitamab discontinuation, and all tests were positive. Median (Q1–Q3) time from tafasitamab discontinuation to CD19 testing was 7 (6–9) days. Among the 9 patients, median (Q1–Q3) time from tafasitamab discontinuation to CAR-T administration was 3.2 (2.3–3.6) months. Four patients had complete response, 3 had partial response, and 1 had progressive disease as best response to CAR-T; 1 patient had data unavailable. This small real-world analysis demonstrated disease response to CAR-T therapy and detectable CD19 expression following tafasitamab treatment, adding to literature investigating treatment outcomes associated with sequential use of anti-CD19 therapies in patients with R/R DLBCL.

BACKGROUND:Glasdegib (GLAS) and venetoclax (VEN) are approved in the US for treating AML in patients aged 75+ or with comorbidities precluding intensive induction chemotherapy. Community oncology outcomes for these therapies are limited. RESEARCH DESIGN AND METHODS:This retrospective chart review summarized characteristics, treatment patterns, and outcomes of US patients treated with first-line (1 L) GLAS or VEN for AML using descriptive statistics. The study was not designed or powered to compare GLAS and VEN cohorts. RESULTS:Among 50 patients receiving 1 L GLAS (82.0% with low-dose cytarabine), 50.0% achieved complete remission (CR), morphological leukemia-free state (MLFS), or partial response (PR). Median overall survival (OS) was 6.9 months (95% CI: 5.4-8.9). A trial-matched GLAS cohort represented 80.0% of all GLAS-treated patients in the study. Among 83 patients receiving 1 L VEN (94.0% with a hypomethylating agent), 51.8% achieved CR, MLFS, or PR, median OS was 8.4 months (95% CI: 5.7-16.2), and 31.3% met pivotal trial eligibility criteria. CONCLUSIONS:This observational study supports the clinical benefit of GLAS and VEN in treating AML patients in the real-world setting.

Importance:Nivolumab is a standard-of-care adjuvant therapy for patients with muscle-invasive urothelial carcinoma (MIUC) at high risk for recurrence after radical resection. However, a better understanding of its use and clinical effectiveness in general patient populations is needed. Objective:To examine treatment patterns and clinical outcomes for patients with MIUC treated with adjuvant nivolumab in a community setting. Design, Setting, and Participants:This nationwide retrospective medical record review cohort study included patients with clinical stage II to IIIB MIUC who initiated adjuvant nivolumab between September 1, 2021, and November 30, 2022, with at least 6 months follow-up (unless deceased in <6 months). Managing physicians from the Cardinal Health Oncology Provider Extended Network abstracted patient data from electronic records. Exposures:Diagnosis of MIUC and receipt of adjuvant nivolumab. Main Outcomes and Measures:Disease-free survival (DFS) and overall survival (OS) were estimated using Kaplan-Meier methods. Results:Data from 253 patients were included in this study, with median (IQR) follow-up from adjuvant nivolumab initiation of 12.8 (9.6-15.4) months. The median (IQR) age at MIUC diagnosis was 67.8 (61.5-72.4) years, and most patients were male (169 patients [66.8%]). Overall, 141 patients (55.7%) had received neoadjuvant chemotherapy (NAC). During adjuvant nivolumab, 52 patients (20.6%) experienced an adverse event (AE). At last follow-up, the median (IQR) duration of adjuvant nivolumab was 11.2 (8.4-12.0) months, and 220 patients (87.0%) had discontinued treatment. Discontinuation was primarily due to completion of scheduled therapy duration (163 of 220 patients [74.1%]), while 10 of 220 patients (4.5%) discontinued due to AEs. Median DFS and OS were not reached, and estimates at 12 months after initiation were 86.3% (95% CI, 81.0%-90.2%) for DFS and 90.8% (95% CI, 86.0%-94.0%) for OS. Outcomes were similar in patients who did not receive NAC. At last follow-up, 226 patients (89.3%) were alive, of whom 209 (92.5%) were disease-free. Conclusions and Relevance:This retrospective medical record review cohort study of patients with MIUC found clinical outcomes consistent with those observed in the CheckMate 274 trial. These results support the use of adjuvant nivolumab for patient populations in the community, including patients who did not receive NAC. Further research with extended follow-up is needed to elucidate long-term clinical outcomes of adjuvant nivolumab.

In the management of immune thrombocytopenia (ITP), an autoimmune disorder characterized by low platelet counts (PCs) and an increased risk of bleeding, thrombopoietin receptor agonist (TPO-RA) therapies are frequently used as second-line treatments following the failure of steroids and/or immunoglobulin therapy. While all three approved TPO-RAs (romiplostim [ROMI], eltrombopag [ELT], avatrombopag [AVA]) target the thrombopoietin receptor, they differ in their binding site, route of administration, hepatotoxicity, and dietary restrictions. Real-world (RW) studies have shown strong effectiveness in patients with chronic ITP who switched to AVA from a prior TPO-RA (i.e., ELT or ROMI), including those with an inadequate response. However, available data is limited by small sample sizes, the unavailability of comprehensive PC data, and short duration of follow-up. This study aims to describe treatment patterns and outcomes in adult patients with primary ITP who switched treatment from ELT or ROMI to AVA in a predominantly community-based setting. This retrospective chart review study used the Cardinal Health Oncology Provider Extended Network (OPEN). Eligible patients were adults with primary ITP who initiated ELT or ROMI on or after July 1, 2019, switched to AVA within 30 days of discontinuing ELT or ROMI, and had ≥6 months follow-up after AVA initiation. Patients who died within 6 months of AVA initiation were eligible for the study, and patients were not required to remain on AVA throughout the study period. Patients were followed from AVA initiation until date of last contact, death, or study end (21-Mar-2025), whichever occurred first. Treatment response was defined as achieving ≥1 PC above the PC response thresholds (i.e., ≥30x109/L, ≥50x109/L, or ≥100x109/L) at any time during AVA treatment in the absence of rescue therapy. Durability of response was defined as the percentage of time on AVA with PC above the response threshold without the use of rescue therapy. Medical charts for 201 patients who switched to AVA (100 ELT-to-AVA; 101 ROMI-to-AVA) were abstracted. The cohort was majority White (59.2%) and female (60.7%). The mean age at AVA initiation was 56.7 years (SD: 12.4) and median time from primary ITP diagnosis to AVA initiation was 14.6 months (IQR: 8.4-25.2). The mean follow-up duration from AVA initiation was 13.0 months (SD: 10.7). Most common reasons for discontinuing the prior TPO-RA were lack of efficacy (59.2%), patient preference (26.9%), and inconvenient administration (22.9%). Among patients with baseline PCs <30x109/L (n=79; 39.3%), 98.7%, 94.9%, and 49.4% achieved responses ≥30x109/L, ≥50x109/L, and ≥100x109/L on AVA, respectively. Most patients with baseline PCs <50x109/L (95.6%; 108/113) achieved a response ≥50x109/L while on AVA. Mean durability of response was 90.8% (SD: 10.4%), 80.5% (SD: 22.1%), and 61.0% (SD: 29.9%) for PC thresholds ≥30x109/L, ≥50x109/L, and ≥100x109/L, respectively. Both patients receiving concomitant steroids at AVA initiation discontinued while on AVA. Rescue therapy was administered to 10.4% (21/201) of patients while on AVA. At last follow-up, 81.1% (163/201) of patients were still receiving AVA, with a median AVA treatment duration of 8.4 months (IQR: 6.7-10.8). Among patients who discontinued AVA, 47.4% (18/38) discontinued due to achieving target PC levels or remission, 10.5% (4/38) due to adverse events, and 5.3% (2/38) due to death. At last follow-up, 66.7% (24/36) of patients who discontinued AVA for reasons other than death had not received any subsequent ITP treatment. None of the patients who discontinued AVA due to achieving target PCs or remission (n=18) had received subsequent ITP treatment, with a median follow-up duration after AVA discontinuation of 10.0 months (IQR: 4.6-13.2). Response and durability of response with AVA were generally similar for patients switching from ELT or ROMI. In this RW study evaluating the effectiveness of AVA treatment following a switch from ELT or ROMI, most patients achieved or maintained a clinically meaningful and durable platelet response throughout the study observation period. The need for rescue therapy was rare and all patients on concomitant steroids were able to discontinue them, further supporting the effectiveness of AVA in patients with primary ITP who switched from ELT or ROMI.

354 Background: PSADT is one of the strongest predictors of outcomes in patients (pts) with BCR PC and a criterion for HR BCR definition. As such, it is crucial to determine whether physicians are aware of pts’ PSADT and how this influences Tx in routine practice. We compared Tx patterns in pts with HR BCR whose PSADT was known (kPSADT) or unknown (uPSADT) by the physician. Methods: This physician-abstracted chart review used data of pts with HR BCR from the Cardinal Health Oncology Provider Extended Network (2018–2020) in the US. HR BCR definition: PSADT ≤9 months (mo) with PSA at or above the threshold per the EMBARK trial. Follow-up was from the index date (date on which HR BCR definition was met) until disease progression, last follow-up, or death through 2022. Physicians reported PSADT in case report forms (CRFs) using doubling time from labs, clinical judgement, or an online calculator (kPSADT). If not provided in the CRF, PSADT was calculated retrospectively based on PSA values up to the index date that the physician had entered in the CRF (uPSADT). We analyzed time to treatment after index via the Kaplan–Meier method. Results: Among 284 pts with HR BCR, median time from initial PC diagnosis to the end of follow-up was 39.1 mo; most pts had kPSADT). There were differences between in age, time from localized PC diagnosis to BCR, Gleason score, and PSA at initial diagnosis and at BCR (Table). A higher proportion of pts with uPSADT had a fast PSADT (≤3 mo) (61% vs 20%, P < 0.001). A higher proportion of pts with kPSADT (64%) vs uPSADT (17%) received Tx within 60 days after index, with a shorter median time to Tx (1.0 vs 6.7 mo; HR: 3.4, 95% CI: 2.6–4.4, P < 0.0001). Conclusions: Most physicians did not know their pts’ PSADT. Even though pts with HR BCR PC who had kPSADT were older and had slower PSADT, they were over three times more likely to receive Tx vs pts with uPSADT. The results suggest that many pts with HR BCR PC may be missed in clinical practice, which limits these pts’ opportunity to receive guideline-concordant Tx to delay progression. Characteristics of index kPSADTn = 104 uPSADTn = 180 P value Age (years), mean (SD) 70.0 (7.6) 65.6 (7.0) <0.001 Primary definitive PC Tx, n (%) Radiotherapy 28 (27) 51 (28) Prostatectomy 76 (73) 129 (72) Time from localized PC diagnosis to BCR ≤2 years, n (%) 97 (93) 143 (79) 0.002 Gleason score ≥8, n (%) 76 (73) 81 (45) <0.001 PSA before initial localized PC diagnosis (ng/mL), median (IQR) 9.0 (6.7) 7.9 (8.6) 0.019 PSA at BCR (ng/mL), median (IQR) 3.4 (9.0) 2.6 (2.8) <0.001

Introduction: Tafa is a CD19-targeting immunotherapy indicated in combination with lenalidomide (len) for the treatment of R/R DLBCL in adult patients (pts) ineligible for autologous stem cell transplantation. To date, few studies have examined tafa in a US real-world setting, especially from a community practice perspective. We presented results from one such real-world study (RWS), but the limited median follow-up time of 6.5 months precluded robust evaluations of the clinical benefits of tafa (Saverno K, et al. Blood. 2023;142(suppl 1):265). Herein, we examined the effectiveness of tafa among pts in this RWS after additional follow-up data were collected. Methods: A retrospective, multisite, physician-abstracted medical chart review was conducted in US adults who initiated tafa (with or without len) on or after October 21, 2020, for R/R DLBCL outside of the clinical trial setting. Initial data collection occurred from February 22 to March 29, 2023, during which 23 physicians from Cardinal Health's Oncology Provider Extended Network abstracted data for 181 pts. Approximately 10 months later, between December 18, 2023 and January 31, 2024, the physicians were asked to provide data on the 144 pts who were still alive at the last follow-up from the initial data collection. These data were merged with the original data and summarized using descriptive statistics; time-to-event endpoints were calculated using the Kaplan-Meier method. Univariable analyses were conducted to assess potential associations between pt demographic, clinical, and treatment characteristics, with the following endpoints of interest: real-world progression-free survival (rwPFS) and overall survival (rwOS). Variables with P≤0.2 in univariable analyses were included in initial multivariable Cox proportional hazards (PH) models. Backwards selection with P<0.05 was used to determine factors, when adjusted for others, associated with rwPFS and rwOS among pts who had initiated tafa for R/R DLBCL. Results: After the most recent data collection, median (Q1-Q3) follow-up time from tafa initiation among the overall study population of 181 pts (male, 56%; White, 64%; median age at tafa initiation, 71 years; received tafa in second line [2L], 72%) was 14.7 (8.5-17.1) months. A total of 128/181 pts (71%) had discontinued tafa; reasons for discontinuation included progression of disease (POD, 71%; clinically defined POD, 9%; POD confirmed on imaging, 62%), toxicity (10%), pt/caregiver request (7%), complete response (rwCR, 4%), and other reasons (8%). Fifty-three of the 106 pts (50%) who were still alive were receiving tafa; 75/181 were reported deceased. Of the 181 pts, 42 (23%) had a rwCR and 91 (50%) had a partial response (rwPR) as their best response to tafa, resulting in a real-world overall response rate (95% CI) of 73% (67%-80%). Among those who achieved a rwCR or rwPR, median (95% CI) duration of response (mDOR) was 9.6 (8.3-13.3) months. mDOR (95% CI) was 19.2 (8.8-not evaluable [NE]) months among those achieving a rwCR and 8.5 (6.8-10.0) months among those with a rwPR as best response. Median rwPFS (95% CI) was 11.3 (9.8-13.6) months and median rwOS (95% CI) was 24.8 (17.8-NE) months from tafa initiation. In the multivariable Cox model, the factors associated (P<0.05) with increased risk of progression included tafa in 3-5L vs 2L, bulky vs nonbulky disease, Ann Arbor stage III-IV vs stage I-II, and increasing National Cancer Institute Charlson Comorbidity Index scores. To overcome violation of PH assumption caused by the variable Eastern Cooperative Oncology Group performance status (ECOG PS), coefficients were adjusted for ECOG PS ≥2 vs <2 through stratifying the model on ECOG PS. Additionally, a Cox PH model found the following factors to be associated with an increased risk of mortality: increasing age, tafa in 3-5L vs 2L, bulky vs nonbulky disease, and ECOG PS ≥2 vs <2. Conclusions: Additional follow-up time allowed for a more robust evaluation of the real-world effectiveness of tafa in a diverse population of pts with R/R DLBCL who received tafa predominantly in a community practice setting. The outcomes observed in this RWS support the clinical benefit of tafa. Furthermore, the multivariable models of rwOS and rwPFS suggest the greatest benefit from tafa is achieved when used as 2L therapy vs later lines of therapy (3-5L).

Abstract Objectives: Historically, African-American/Black patients with bladder cancer have worse clinical outcomes compared with White/Caucasian patients. In the CheckMate 274 trial, nivolumab demonstrated a significant improvement in disease-free survival compared with placebo among patients with MIUC at high risk of recurrence following radical surgery; however, African-American/Black patients were underrepresented (< 1%). The objective of this analysis was to describe the characteristics and outcomes of MIUC patients treated with adjuvant nivolumab across different racial subgroups in a real-world setting. Methods: This US retrospective medical chart review included African-American/Black and White/Caucasian patients with MIUC treated with adjuvant nivolumab following radical resection between 01-Sep-2021 and 10-Sep-2022. Patient characteristics and outcomes were abstracted from the medical charts by treating oncologists. Patient characteristics and landmark survival estimates based on Kaplan-Meier analyses were summarized descriptively. Results: The analysis included 223 patients (African-American/Black: 62; White/Caucasian: 161). A numerically higher proportion of African-American/Black vs White/Caucasian patients, respectively, was male (74.2% vs 66.5%), less than 60 years old (27.4% vs 20.5%), unemployed (16.1% vs 5.6%), and had Medicaid at therapy initiation (14.5% vs 6.2%). Similar proportions in both groups had ECOG performance status 0-1 (82.3% vs 82.6%), received neoadjuvant therapy (58.1% vs 56.5%), and completed adjuvant therapy (67.7% vs 66.5%). The median follow-up time (12.5 months vs 13.1 months) and median duration of adjuvant therapy (11.0 months vs 11.3 months) were comparable. Similar estimates were observed for 12-month overall survival (96.7% vs 91.4%), 12-month disease-free survival (88.3% vs 88.4%), and 12-month distant metastasis-free survival (88.3% vs 88.4%). Conclusions: Despite higher rates of socio-economic risk factors among African-American/Black patients, this real-world study suggests similar effectiveness of adjuvant nivolumab among MIUC patients across African-American/Black and White/Caucasian patient populations. Citation Format: Regina Barragan-Carrillo, Alexander Chehrazi-Raffle, Bruce Feinberg, William S. John, Taavy A. Miller, Sarah Lucht, Prathamesh Pathak, Emily Bland, Sarah Gordon, JaLyna Laney, Andrew J. Klink, Hedyeh Ebrahimi, Nisha Singh, Carmelo Alonso, Miraj Patel, Lisa Rosenblatt, Xin Yin. Racial differences in characteristics and outcomes of adjuvant nivolumab for muscle-invasive urothelial carcinoma (MIUC) in the real-world setting [abstract]. In: Proceedings of the AACR Special Conference on Bladder Cancer: Transforming the Field; 2024 May 17-20; Charlotte, NC. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(10_Suppl):Abstract nr A008.

Aim: In rheumatoid arthritis (RA), seropositivity for both anticitrullinated protein antibody (ACPA) and rheumatoid factor (RF) is associated with disease severity and therapeutic response. Biologic (b) disease-modifying antirheumatic drugs (DMARDs) such as abatacept are recommended after inadequate response or contraindication to conventional synthetic DMARDs. This retrospective cohort study aimed to describe changes in Clinical Disease Activity Index (CDAI) measures over 12 months among patients with ACPA+ and RF+ RA with an inadequate response to methotrexate treated with abatacept as a first-line bDMARD. Patients & methods: Patient data were abstracted from medical records by treating rheumatologists. Analyses included McNemar tests for paired proportions or paired t -tests to assess longitudinal changes in CDAI scores, and Kaplan–Meier methods for time-to-event outcomes. Serious AEs and rationale for initiating treatment were recorded. Results: Overall, 296 patients were included. Mean CDAI scores improved (decreased) by 34.0, 61.0 and 74.0% (all p < 0.001) from baseline to 3–6 months, 6–12 months and ≥12 months after abatacept initiation, respectively. Of 279 patients not in CDAI low disease activity (LDA) or remission at baseline, 24.7% of patients achieved it within 6 months, 56.3% within 12 months and 71.0% at any point during follow-up after abatacept initiation. Median time to CDAI LDA/remission was 10.2 months. Serious AEs were reported in 2.4% of patients. Common reasons reported by rheumatologists for initiating abatacept were effectiveness/efficacy (52.7%), safety (31.4%) and patient preference (25.3%). Conclusion: In this analysis of patients with ACPA+ and RF+ RA treated with abatacept as a first-line bDMARD in a clinical practice setting, clinical outcomes and remission rates were improved at all time points, providing real-world evidence to further support the use of abatacept in this patient population.

Objectives: Diffuse large B-cell lymphoma (DLBCL) is an aggressive lymphoma with variable prognoses. Patients with primary refractory DLBCL tend to have poor outcomes with second-line therapy and beyond. Tafasitamab, a CD19-targeting immunotherapy, combined with lenalidomide, is approved by the US Food and Drug Administration for relapsed or refractory (R/R) DLBCL in adults ineligible for autologous stem cell transplantation. In a recent real-world study, over one in four patients receiving tafasitamab for R/R DLBCL had primary refractory disease. Here, we describe patient characteristics, treatment patterns, and clinical outcomes observed in this study by primary refractory status. Material and methods: In this retrospective cohort study, participating physicians from Cardinal Health's Oncology Provider Extended Network abstracted data from eligible patients’ medical records into electronic case report forms. Eligible patients were aged ≥18 years, initiated tafasitamab for R/R DLBCL on or after October 21, 2020, and had ≥4 months of follow-up (however, otherwise eligible patients who died during follow-up were also included). Results were summarized by primary refractory status using descriptive statistics. Primary refractory was defined as disease progression while receiving or ≤6 months after completion of first-line therapy. Tafasitamab treatment duration was estimated using the Kaplan-Meier method. Results: The analysis included 181 patients, 47 (26%) with primary refractory and 134 (74%) with nonprimary refractory disease. At tafasitamab initiation, 43% of patients in the primary refractory and 49% in the nonprimary refractory subgroups had ECOG PS ≥2, and most patients had revised International Prognostic Index scores of 3-5 (primary refractory, 83%; nonprimary refractory, 80%). Median (Q1-Q3) follow-up from tafasitamab initiation in the primary refractory and nonprimary refractory subgroups was 5.7 (4.6-7.6) and 6.5 (5.1-9.2) months, respectively. Most patients received tafasitamab as second-line treatment (primary refractory, 70.2%; nonprimary refractory, 72.4%). Median (95% CI) duration of tafasitamab treatment in the primary refractory and nonprimary refractory subgroups was 11.0 (5.8-14.1) and 11.9 (10.5-16.8) months, respectively. Real-world overall response rate (95% CI) was 61.7% (47.8-75.6%) for the primary refractory and 73.1% (65.6-80.6%) for the nonprimary refractory subgroups. At the time of data collection, 35 patients (74.5%) with primary refractory disease and 109 patients (81.3%) with nonprimary refractory disease were still alive, of whom 27 (77.1%) and 94 (86.2%) were still receiving tafasitamab, respectively. Discussion: Findings from this study indicate that real-world overall response rates to tafasitamab were favorable among patients with primary refractory and nonprimary refractory DLBCL. Most patients who were alive at time of data collection were still receiving tafasitamab. A limitation is the relatively short follow-up time. Conclusion: This analysis supports the clinical benefit of tafasitamab treatment for patients with primary refractory and nonprimary refractory disease. Longer follow-up is required to evaluate long-term outcomes with tafasitamab treatment among patients with primary refractory DLBCL. Funding: Incyte Corporation.

Objectives: Potential CD19 antigen loss following CD19-directed therapy has raised concerns over sequential use of these therapies, and real-world data are limited. Tafasitamab, a CD19-targeting immunotherapy, combined with lenalidomide, is approved by the US Food and Drug Administration for treatment of relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) in adults ineligible for autologous stem cell transplantation. Here, we examine characteristics and outcomes of patients who received tafasitamab for R/R DLBCL preceding CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy in a real-world setting. Material and methods: In this retrospective, multisite, medical chart review study, participating physicians from Cardinal Health's Oncology Provider Extended Network abstracted data from US adults who initiated tafasitamab (with or without lenalidomide) on or after October 21, 2020, for R/R DLBCL outside clinical trial settings. Patients were required to have ≥4 months of follow-up after tafasitamab initiation unless deceased. Initial data collection (February-March 2023) identified 181 eligible patients, and follow-up data were collected approximately 10 months thereafter. Results for patients who received tafasitamab preceding CAR-T therapy were summarized using descriptive statistics. Results: Nine patients (median age at tafasitamab initiation, 63 years; 3 male; 6 White) received tafasitamab and lenalidomide (tafa+len) as a line of therapy immediately preceding CAR-T therapy. Median (Q1-Q3) follow-up time since tafasitamab initiation was 26.1 (18.0-28.0) months and after CAR-T administration was 9.3 (1.9-16.7) months. At tafasitamab initiation, 7 patients had Eastern Cooperative Oncology Group performance status 0-1 and 2 had primary refractory disease. Of the 9 patients, 4 had complete response, 4 had partial response, and 1 had stable disease as best real-world response to tafa+len; all discontinued tafasitamab due to disease progression. Median (Q1-Q3) tafasitamab therapy duration was 11.0 (8.1-14.1) months. Three patients had CD19 testing following tafasitamab discontinuation, and all test results were positive. Median (Q1-Q3) time from tafasitamab discontinuation to CD19 testing was 7 (6-9) days. Among the 9 patients, median (Q1-Q3) time from tafasitamab discontinuation to initiation of CAR-T therapy was 3.2 (2.3-3.6) months. Four patients had complete response, 3 had partial response, and 1 had progressive disease as best real-world response to CAR-T therapy; 1 patient was not evaluable. Discussion: These results suggest that in patients treated with tafasitamab, CD19 expression remains detectable following treatment discontinuation, and disease response can be achieved with subsequent CD19-directed CAR-T therapy. However, this study is limited by small sample size. Conclusion: This small real-world analysis demonstrated disease response to CD19-directed CAR-T therapy and detectable CD19 expression following tafasitamab treatment for R/R DLBCL. Further studies with larger sample sizes are warranted to confirm these findings. Funding: Incyte Corporation.

Context Potential CD19 antigen loss following CD19-directed therapy has raised concerns over sequential use of these therapies. Tafasitamab, a CD19-targeting immunotherapy, combined with lenalidomide, is approved for R/R DLBCL treatment in adults ineligible for autologous stem cell transplantation. Objective Examine characteristics and outcomes of patients who received tafasitamab preceding CD19-directed CAR-T therapy in a real-world setting. Design Retrospective, multisite, physician-abstracted medical chart review of US adults who initiated tafasitamab (with or without lenalidomide) on or after October 21, 2020, for R/R DLBCL outside clinical trial settings. Patients were required to have ≥4 months follow-up after tafasitamab initiation unless deceased. Initial data collection (February-March 2023) identified 181 eligible patients, and follow-up data were collected ~10 months thereafter. Results for patients who received tafasitamab preceding CAR-T therapy were summarized using descriptive statistics. Results Nine patients (median age at tafasitamab initiation, 63 years; 3 male; 6 White) received tafasitamab and lenalidomide (tafa+len) as a line of therapy immediately preceding CAR-T therapy. Median (Q1-Q3) follow-up time since tafasitamab initiation was 26.1 (18.0-28.0) months and after CAR-T administration was 9.3 (1.9-16.7) months. At tafasitamab initiation, 7 patients had Eastern Cooperative Oncology Group performance status 0-1 and 2 had primary refractory disease. Of the 9 patients, 4 had complete response, 4 had partial response, and 1 had stable disease following tafa+len; all discontinued tafasitamab due to disease progression. Median (Q1-Q3) tafasitamab therapy duration was 11.0 (8.1–14.1) months. Three patients had CD19 testing following tafasitamab discontinuation, and all test results were positive. Median (Q1-Q3) time from tafasitamab discontinuation to CD19 testing was 7 (6-9) days. Among the 9 patients, median time (Q1-Q3) from tafasitamab discontinuation to initiation of CAR-T therapy was 3.2 (2.3-3.6) months. Four patients had complete response, 3 had partial response, and 1 had progressive disease as best real-world response to CAR-T therapy; 1 patient was not evaluable. Conclusion This small real-world analysis demonstrated disease response to CD19-directed CAR-T therapy and detectable CD19 expression following tafasitamab treatment.