Aim: In oncology trials, blinded independent central review (BICR) is the standard for treatment response classification. Real-world data methodologies that align with BICR may reduce misclassification in realworld evidence (RWE) studies and enhance reproducibility, increasing value of RWE. We aimed to develop and validate a novel real-world data-based methodology – real-world Lugano (rwLugano) – for assessing lymphoma response to align with clinical trials. Materials & methods: We conducted a retrospective, multisite chart abstraction study using Cardinal Health Practice Research Network (PRN) sites to identify adults with diffuse large B-cell lymphoma initiating first-line (1L) therapy from 1 January 2015, through 31 December 2022, in US community oncology. Sites collected patient characteristics and PET/CT scans at baseline and first response. Two radiologists independently classified responses; a medical oncologist adjudicated discordances. Results: We compared initial treatment responses using three methods: physician-charted from electronic health records, rwLugano-derived per Lugano 2014 and BICR-adjudicated per Lugano 2014. Agreement was assessed via percentage concordance, kappa (κ), and multivariable generalized linear mixed modeling for assigning complete response (CR). Among 178 patients, CR rates were 63.5% (physician-charted), 81.5% (rwLugano) and 83.1% (BICR). Compared with BICR, rwLugano showed higher agreement (87.9%, κ = 0.52) than physician-charted (77.0%, κ = 0.40). The generalized linear mixed modeling analyses identified clinical factors associated with concordance: for physician charted assessments, greater numbers of extranodal sites increased agreement with BICR (OR 1.92), while MYC mutation (OR 0.38) and anemia (OR 0.37) reduced agreement. For rwLugano, nonprivate insurance was associated with higher agreement (odds ratio [OR]: 4.40), whereas MYC mutation reduced agreement (OR: 0.26). Conclusion: rwLugano improves real-world lymphoma response classification, aligning with BICR and supporting more accurate, reproducible RWE for clinical and regulatory decision-making. Using methods BICR and rwLugano may provide opportunities to minimize outcome misclassification and improve comparability of clinical trial and clinical practice approaches.

6575 Background: Pacritinib (PAC), a JAK1-sparing JAK2/IRAK1/ACVR1 inhibitor has shown spleen volume and symptom improvement in clinical trials of in patients (pts) with myelofibrosis (MF) with similar benefits in the real-world. This analysis evaluated real-world outcomes in pts with MF and platelet counts (PLT) ≥50 x10 9 /L at PAC initiation. Methods: This was a multisite chart review of pts with MF treated with PAC for ≥1 month between 06/01/2022 and 07/31/2024 with ≥6 months of follow-up through 01/31/2025. Pts were followed from PAC initiation (index) until the earliest of end of the study, the end of data availability for the pt, or death. Evaluated data included Pt characteristics, treatment patterns, palpable spleen length (total spleen length minus 10cm) and spleen size category based on palpation or palpable spleen length below costal margin (not palpable/minimally palpable <5 cm below costal margin; mild: 5-10 cm palpable; moderate: 11-20 cm palpable; severe: >20 cm palpable), PLT, hemoglobin (Hb), MF-related symptoms, and overall survival through Day 180. Results for pts with PTL ≥50 x10 9 /L at index are described using counts and percentages, medians and interquartile range (IQR), and survival probabilities. Results: Of 169 pts with MF treated with PAC, 27% (45/169) had PLT ≥50 x 10 9 /L at index. Median age was 67 years (IQR: 62-74) at diagnosis and median time from diagnosis to index was 6 months (IQR: 1.3-14.3). The median duration of follow-up from index was 7.6 months (IQR: 6.7-11.0) and 82% of pts (n=37) were still on PAC at end of follow-up. Of 12 pts with spleen length measured by ultrasound at index and Day 180, median spleen length reduction (SLR) was 39% (IQR: 30.4-48.3) with 83% (10/12) achieving SLR ≥25% by Day 180. Among those with categorical spleen size based on palpation (n=5) or ultrasound (n=12), 53% (9/17) achieved a reduction in spleen size category. No pts had a worsening in spleen size category, and spleen size category remained stable for 47% (8/17) of pts. At index, all but one pt had ≥1 MF-related symptom. By Day 180, 80% (35/44) experienced a reduction in the number of symptoms, with a median reduction of 67% (IQR: 33-75). Median PLT at index was 72 x 10 9 /L (IQR: 53-110) and from index to Day 180, median increase in PLT was 14% (n=38, IQR: 0-30). Among pts with PLT ≤100 x10 9 /L at index 20% (6/30) achieved an increase of ≥30x10 9 /L. At index, median Hb was 8.8 g/dL (IQR: 8.0-9.7). Among 29 pts with Hb <10 g/dL at index and Hb at Day 180, Hb increased by a median of 0.8 g/dL (IQR: -0.1-1.0), with 31% (9/29) achieving an increase ≥1.0 g/dL. Overall survival by the end of follow-up was 89% (40/45), and 6-month survival probability was 93% (95% confidence interval: 81, 98). Conclusions: Similar to clinical trials, pts with MF and higher PLT counts treated with PAC in the real-world also experienced reduction or stabilization in spleen size category, decreased MF-symptom burden, PLT stability, and improved Hb.

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.

501 Background: EC remains a global health challenge with a rising incidence and poor prognosis despite advancements in treatment modalities. Standard therapies include surgery, chemotherapy (CT), radiation therapy, and recently, targeted and immunotherapy. The PD-L1 inhibitors pembrolizumab (pembro) and nivolumab (nivo) received FDA approval for frontline treatment in EC in March and May 2021, respectively, based in part on the KEYNOTE-590 (KN590) and CheckMate 648 trials. In this study, we aimed to uncover rationale in physician preference for PD-L1 inhibitors in EC. Methods: US-based oncologists convened at two in-person meetings in April 2024 to discuss clinical and real-world data presented at the 2024 ASCO GI Cancers Symposium. Among data discussed included the KN590 5-year update. Survey questions were fielded at the meeting to capture participants’ impressions. Demographics were captured via an online survey ahead of the meeting. Responses from participants who manage EC and responded to all survey questions were aggregated. Results: 86 participants qualified; and, collectively, are 76% community physicians with 18 years average in clinical practice, see 18 patients median on clinic days, and spend 83% of their time in direct patient care on average. ECOG PS status (50%), tumor histology (52%), and location/stage (48%) were reported as critical factors in treatment decision-making; only 14% said PD-L1 status was a major factor. Participants were queried on a hypothetical patient case of esophageal squamous cell and adenocarcinoma before and after reviewing the KN590 data. Prior to reviewing KN590, physician preferences in the squamous cell 1L setting were split between nivo+CT and pembro+CT; following data review, pembro+CT was favored nearly 3:1. In the adenocarcinoma 1L setting, preference shifted from 60/40 nivo+CT to 60/40 pembro+CT, see Table. The cohort were most impressed with the overall survival (87%) and objective response rates (40%), and 55% would consider pembro+CT for both squamous cell and adenocarcinoma disease while 37% would consider it for PD-L1 CPS>10 squamous cell disease only. Conclusions: Our study showed PD-L1 status was not a major factor in clinical decisions. The shift in treatment preference toward pembro+CT for both patient cases following KN590 data review suggests an impact for data review to influence physician behavior. This highlights the importance of educational initiatives to disseminate clinical updates to providers. It is still to be determined the optimal platform and length for these initiatives, and to quantify their effectiveness. 65-year-old male patient with advanced EC;PD-L1 CPS ≥10;ECOG PS of 1 Squamous cell disease Adenocarcinoma Before After Before After Fluoropyrimidine (FP) + platinum (P)-based CT 1% 1% 1% 0% FP +P-based CT + nivo 55% 27% 60% 36% FP + P-based CT + pembro 43% 71% 38% 63% Nivo + ipilimumab 1% 1% 0% 1% None of the above 0% 0% 0% 0%

e19561 Background: One of the major factors influencing the choice of triplet versus quadruplet therapies in TIE ND MM is performance status (i.e., patient frailty). The IMROZ (NCT03319667) and BENEFIT (NCT04751877) trials both evaluate the efficacy and safety of the quadruplet regimen isatuximab plus bortezomib, lenalidomide, and dexamethasone (Isa-VRd) in TIE ND MM. We evaluated perceptions of the managing providers on the choice of quadruplet versus triplet induction therapy for the TIE ND MM population. Methods: In September and October 2024, US-based hematologists/oncologists convened at two live meetings to discuss healthcare trends in oncology, including the IMROZ and BENEFIT trials. An online premeeting survey was used to collect participants’ demographics. Participants’ experiences and management strategies surrounding TIE ND MM were captured via an audience response system during the live meeting; not all participants answered every question. Responses were aggregated and analyzed using descriptive statistics. Results: Among 94 participants, 83.0% were community providers, saw an average of 20 patients on clinic days, and had a median of 19 (2−49) years in practice. Half of participants (49.6%) reported that 40% or less of their patients with TIE ND MM were initiated on a quadruplet therapy within the past 3 months. Participants reported patient disease risk status (66.7%), patient frailty (53.3%), and treatment efficacy and safety (both 46.7%) as their top 3 factors influencing their preference of quadruplet versus triplet therapy in TIE ND MM. When presented with two standard-risk, 70-year-old patients with TIE ND MM who differed only in frailty (i.e., non-frail and frail), the majority of participants (44.6% and 53.6%, respectively) reported daratumumab plus lenalidomide and dexamethasone (DRd) as their preferred treatment. After reviewing both the IMROZ and BENEFIT trials, the majority of participants shifted their preference to Isa-VRd (44.6% à 73.8%) for the equivalent non-frail patient. For frail patient, while DRd (42.9%) was still the most preferred choice, there was a significant increase in the preference for Isa-VRd (5.8% à 31.0%). Conclusions: We show that the IMROZ and BENEFIT data significantly shifted the preference of induction regimen from DRd triplet in all comers with TIE ND MM to Isa-VRd quadruplet for fit patients. While Isa-VRd quadruplet is still not preferred in the frail population, there was a significant increase in the willingness to use it. This data reaffirms the impact and influence patient frailty and provider education has on the choice of induction therapy in TIE ND MM. Future research is needed to evaluate how other factors, including disease risk status, play a role in decision-making between triplet and quadruplet therapies.

487 Background: Axitinib (AXI) with pembrolizumab (PEM) is approved for first line (1L) treatment of advanced renal cell carcinoma (aRCC). This study provides real-world evidence of treatment patterns and outcomes in 1L aRCC patients treated in primarily community practice settings. Methods: This retrospective, multicenter, community oncologist-based chart review study used the Cardinal Health Oncology Provider Extended Network (OPEN). Patients with age ≥18 years, stage IV clear cell aRCC diagnosis, 1L AXI+PEM initiation between 22-Apr-2019 to 22-Feb-2024, and ≥6 months follow-up were included. Descriptive statistics were used to report demographics and treatment patterns. Duration of therapy (rwDOT) was defined as start date to discontinuation date of 1L AXI+PEM (any cause). Progression-free survival (rwPFS) was defined as start of 1L AXI+PEM to physician-reported progression or death. Results: Physicians (n=25) abstracted data for 300 patients, who were a median age of 66.7 years (interquartile range [IQR]: 60.0-72.8), 61.0% (n=183) male, 69.3% (n=208) White, and 11.3% (n=34) with sarcomatoid features. International Metastasis RCC Database Consortium risk groups for patients were 18.0% favorable, 59.3% intermediate, and 21.7% poor risk (n=3 unknown). Median follow-up overall was 12.3 (IQR: 8.1-21.6) months. Most patients (95%; n=285) started AXI at the initial recommended dose of 5 mg twice daily (BID; Table). Few patients (14.3%; n=43) required AXI dose reductions, with a median time to first AXI dose reduction of 2.3 months (IQR: 1.4-3.7), while 8.7% (n=26) of patients were able to dose escalate (7.3% [n=22] to 7 mg BID; 1.3% [n=4] to 10 mg BID). At data collection, 44.7% (n=134) of patients had discontinued AXI+PEM (78.7% due to progression; 7.8% due to adverse events). Median rwDOT of 1L AXI+PEM was 11.7 (IQR: 7.0-18.5) months and 12-month rwPFS was 74.3% (95% confidence interval: 68.3-79.4). Conclusions: This is one of the first comprehensive studies to describe real-world treatment patterns and clinical outcomes of 1L AXI+PEM for aRCC patients in the US community setting. The majority of patients were able to start 1L AXI+PEM at the FDA-recommended initial dose, with a minority of patients requiring dose reductions. Further prospective studies investigating the impact of 1L AXI+PEM treatment modification on clinical outcomes for aRCC are needed. Initial AXI regimen: 5 mg orally BID (n, %) 285, 95.0 Time from 1L initiation to first AXI decrease (months; median, IQR) 2.3, 1.4-3.7 Time from 1L initiation to first AXI increase (months; median, IQR) 0.5, 0.5-2.8 AXI dose/frequency after first decrease (n, %) 43, 14.3 3 mg orally BID 36, 83.7 2 mg orally BID 6, 14.0 Other ( 2 mg BID, 2 weeks on 1 week off) 1, 2.3 AXI dose/frequency after first increase (n, %) 26, 8.7 7 mg orally BID 22, 84.6 10 mg orally BID 4, 15.4

BACKGROUND:Pemigatinib demonstrated efficacy in fibroblast growth factor receptor (FGFR)-altered cholangiocarcinoma (CCA) in the FIGHT-202 trial. However, limited real-world evidence exists on treatment patterns and outcomes in this setting. PATIENTS AND METHODS:Patient characteristics, treatment patterns, and outcomes of US adults who received pemigatinib for unresectable, locally advanced or metastatic CCA were collected via retrospective physician-abstracted chart review. Results were summarized using descriptive statistics. RESULTS:Data from 120 patients (49.2% male; 55.0% White; 19.2% Hispanic; median age at initial pemigatinib prescription, 64.5 years) were collected from 18 physicians/practices. At the time of prescribing, 90.0% of patients had metastatic disease. FGFR2 testing was completed for 92.5% of patients; of those, all but one (result unknown) tested positive, and 95.5% were tested using next-generation sequencing. Pemigatinib was prescribed as second- and third-line therapy among 94.2% and 5.8% of patients, respectively. The most common starting dosage was 13.5 mg daily for 14 days of 21-day cycles (87.5% of patients). Among 60 patients (50.0% of the full cohort) who discontinued pemigatinib during the 6.5-month median study follow-up period, 68.3% discontinued due to disease progression. The median real-world progression-free survival (rwPFS) from the date of pemigatinib initiation was 7.4 months (95% CI: 6.4-8.6), and the real-world overall response rate (rwORR) was 59.2% (95% CI: 50.0%-68.4%). CONCLUSION:This study complements the FIGHT-202 clinical trial by assessing the use of pemigatinib among a diverse population of patients with CCA under real-world conditions. Findings support the clinical benefit of pemigatinib demonstrated in FIGHT-202.

In HER2-negative (HER2-), estrogen receptor-positive (ER+), stage III/IV metastatic breast cancer (mBC), overall survival (OS) and time to progression depend on treatment response as well as patient factors, molecular profiles, and prior therapy. We questioned whether combination chemotherapy + fulvestrant + aromatase inhibitor (AI) + targeted therapy improves OS and delays progression versus chemotherapy + endocrine therapy excluding fulvestrant and AI ± targeted therapy. Using AACR Project Genie, we compared OS (median, 12-, 24-, 36-, 48-, 60-, 72-month landmark) between women treated with chemotherapy + fulvestrant + AI + combination cyclin-dependent kinase 4/6 (CDK 4/6), mammalian target of rapamycin (mTOR), or AKT inhibitor (Group A) versus chemotherapy + combination endocrine therapy excluding fulvestrant + AI with or without targeted therapy with AKT, CDK 4/6, or mTOR inhibitor (Group B). Adjusting for confounding, we used inverse propensity score weighting and Cox proportional hazards to estimate hazard ratios (HRs) with Kaplan-Meier (KM) methods in R v4.4.1. We also compared between-group ages at initial and metastatic diagnosis as time-to-event (TTE) end points. Among 111 patients, adjusted weighted median OS was 89.87 (67.43-not estimable [NE]) months for Group A versus 52.53 (43.06-NE) months for Group B (HR 0.42, 95% CI 0.24-0.75; P<.001). A numeric OS advantage emerged at 24 months in Group A, reached significance at 48 months, and remained at 72 months. Mean TTE was 3 years in Group A versus 1.6 years in Group B (HR 0.60, 95% CI 0.42-0.87; P=.005). In HER2-, ER+, late-stage mBC, we found statistically significantly delayed TTE and a mean 58% OS advantage with chemotherapy plus fulvestrant + AI + targeted therapy over chemotherapy plus endocrine-based regimens excluding fulvestrant and AI. As neither OS nor progression can be attributed to treatment alone, future studies should evaluate these regimens long-term in the context of contributing factors and explore the potential for more personalized care. Alexandrina Balanean, Samuel Baird, Brooke Leon, Parisa Asgarisabet, Camryn Craig, Yolaine Smith, Harlen Hays, Bruce Feinberg, Shahnjayla Connors. Real-world evidence from AACR Project Genie: Overall survival with combination chemotherapy plus endocrine and targeted therapy in HER2-negative, ER-positive metastatic breast cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr LB372.

e21003 Background: Often characterized as exhaustion of physical or emotional strength due to prolonged stress or frustration, physician burnout has become a worsening phenomenon in oncology, especially post the COVID-19 pandemic and with a rising demand for oncology services. This study surveyed oncologists on their current perceptions of burnout, sources of stress, and any burnout management strategies implemented in their practice. Methods: In June 2024, US-based hematologists/oncologists convened at a live meeting to discuss healthcare trends in oncology, including physician burnout. An online premeeting survey was used to collect participants’ demographics. Participants’ experiences and management strategies surrounding burnout were captured via an audience response system during the live meeting. Responses were aggregated and analyzed using descriptive statistics. Results: Among 59 participants, 68% are community providers, see a median of 18 patients on clinic days, and have a median of 20 years in practice. The majority (71%) of participants are now seeing moderately to significantly more patients than 5 years ago; increased cancer incidence (42%), provider turnover/departure (32%), and increased patient quota (28%) are the main factors contributing to increased patient load. Participants indicated various types and sources contributing to work-related stress, with mandatory EHR entries/documentation (77%), notifying patients of treatment outcomes (66%), patients having constant access to providers via EMR portals (64%), and high patient volume (60%) being the most prevalent. Nearly three-fourths of participants feel burned out because of their work and nearly two-thirds feel their work is making them more cynical. Approximately three-fourths feel slightly or significantly more burnout compared to 5 years ago. Over half (52%) indicated that burnout assessments are not done in their practice and when assessment is performed, it most commonly occurs only once per year. The personal-level strategy most often employed by participants to combat burnout is to take time off from work (81%). Further, participants indicated that decreased work hours (46%) and additional support staff (45%) were the top institution-level strategies that would help combat burnout. Conclusions: Over the past 5 years, oncologists have experienced a significant increase in patient load, expanded EHR documentation, and constant accessibility to patients. These stressors and others have led to heightened levels of burnout. While taking time off is a commonly referenced strategy for mitigating burnout, participants suggested that reducing work hours and hiring additional staff could further alleviate stress. Future research should explore the effectiveness of regular burnout assessments and their potential to inform strategies aimed at reducing burnout and improving oncologists’ overall well-being.

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

e19081 Background: Innovation in the use of real-world data (RWD) for regulatory purposes is an important provision of 21st Century Cures Act. Numerous initiatives to enhance RWD methodologies in oncology drug development are ongoing, including evaluation of treatment response assessment to support effectiveness research. Blinded independent central review (BICR) standardizes response assessment in clinical trials, and corresponding RWD methodologies are needed. This study assess feasibility of BICR using RWD, and evaluates a novel, standardized treatment response methodology among patients with diffuse large B-cell lymphoma (DLBCL). Methods: A retrospective multisite chart review identified adult patients with DLBCL treated with first-line chemoimmunotherapy in US (01JAN2015-31DEC2022). Clinical data, including physician-reported response, were abstracted from medical charts and positron emission tomography-computed tomography (PET-CT) reports at treatment initiation and first response assessment. Lugano 2014 criteria, such as standardized uptake value (SUV) and Deauville score, were extracted and converted to an algorithm (rwLugano). Absence of normal tissue SUV in PET-CT reports was addressed using published values for background, mediastinum, and liver to facilitate a real-world Deauville (rwDeauville) score for rwLugano classification. PET-CTs underwent deidentified digital image transfer for BICR using Lugano 2014 criteria by two lymphoma radiologists. Descriptive analyses assessed BICR feasibility and completeness of rwLugano data elements. Results: Six oncology practices, comprising 77 physicians, abstracted medical records and PET-CT reports for 185 patients. PET-CT scans were available for BICR for 174/185 (94%) patients (41% female, mean age 66 years). BICR discordance for Deauville score at baseline and initial response occurred in 7% (12/174) and 29% (50/174), respectively. For response assessment per Lugano, BICR discordance occurred in 9% (16/174), and were further adjudicated by a third party. Lugano discordance was often related to interpretation of marrow activity and/or new disease sites, highlighting variability in lymphoma treatment response assessment. Medical record review found Deauville score charted for 97 (56%) patients at baseline and 145 (83%) at first response. Tumor SUV was complete (174/174, 100%) at baseline and for all patients (63/63, 100%) not charted as CR at first response. Thus, 29 patients (17%) required calculation of rwDeauville at first response, providing data to calculate rwLugano for all patients in the final cohort (174/174, 100%). Conclusions: This study suggests BICR, though resource intensive, can be performed, and the component measures necessary to assess response per Lugano criteria can be obtained using RWD. Accordingly, rwLugano warrants further analysis for concordance with BICR- and physician-reported response.

Real-world patient characteristics and outcomes were assessed in 150 patients with intermediate- or highrisk primary myelofibrosis (MF) who received fedratinib (a Janus kinase 2 inhibitor) following ruxolitinib failure. Fedratinib was associated with significant reductions in spleen size and reported number of MF-related symptoms, illustrating the benefit of fedratinib following ruxolitinib discontinuation. Background: There is a lack of established clinical outcomes for patients with myelofibrosis (MF) receiving fedratinib following ruxolitinib failure. This study examined real-world patient characteristics, treatment patterns, and clinical outcomes of patients with MF treated with fedratinib following ruxolitinib failure in US clinical practice. Patients and Methods: This retrospective patient chart review included adults with a physician-reported diagnosis of MF, who initiated fedratinib after discontinuing ruxolitinib. Descriptive analyses characterized patient characteristics, clinical outcomes, and treatment patterns from MF diagnosis through ruxolitinib and fedratinib treatment. Results: Twenty-four physicians abstracted data for 150 eligible patients. Approximately 55.3% of the patients were male, 68.0% were White, and median age at MF diagnosis was 68 (range, 35-84) years. Median duration of ruxolitinib therapy was 7.6 (range, 0.7-65.5) months. At initiation of fedratinib, 88.0% of patients had palpable spleen and a mean spleen size of 16.0 (standard deviation [SD], 5.9) cm. Spleen size decreased by 19.4% to 13.2 (SD, 7.9) cm at month 3 (P = .0001) and by 53.4% to 7.2 (SD, 7.4) cm at month 6 (P = .01) of fedratinib treatment, respectively. Almost one-third (26.8%) of patients had achieved >= 50% spleen reduction by month 6. Mean number of symptoms also decreased significantly at month 3 (P < .0001) and month 6 (P = .01). Conclusion: Fedratinib appears to deliver spleen and symptom benefits in real-world patients with MF previously treated with ruxolitinib. (c) 2023 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)

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.

Background: Cancer spares no demographic or socioeconomic group; it is indeed the great equalizer. But its distribution is not equal; when structural discrimination concentrates poverty and race, zip code surpasses genetic code in predicting outcomes. Compared with White patients in the United States, Black patients are less likely to receive appropriate treatment and referral to clinical trials, genetic testing, or palliative care/hospice. Methods: In 2021, we administered a survey to 369 oncologists measuring differences in perceptions surrounding racial disparity, racial anxiety, and unconscious bias and adverse in fluence on clinical interactions, treatment, and outcomes for non-White patients. We analyzed responses by generational age group, sex/gender, race/ethnicity, US region, and selection of "decline to respond. " Results: The most signi ficant differences occurred by age group followed by race/ethnicity. Racial disparity was perceived as moderate to very high by 84% of millennial, 69% of Generation X, and 57% of baby boomer oncologists, who were also 86% more likely than millennials and 63% more likely than Generation Xers to perceive low/nonexistent levels of racial anxiety/unconscious bias. Conclusions: Most oncologists rarely or never perceived racial anxiety/unconscious bias as adversely in fluenc- ing clinical treatment or survival outcomes in non-White patients, and White oncologists were 85% more likely than non-White oncologists to perceive rare/nonexistent in fluence on referral of non-White patients to palliative care/hospice. The discrepancy between 62% of oncologists perceiving moderate to very high levels of racial anxiety/unconscious bias and 37% associating them with adverse in fluence on non-White patients shows a disconnect, especially among older oncologists (baby boomers), who were also least likely to select the decline option. Together, these factors hinder effective patient -provider communication and result in differential care and outcomes. Oncologists should uncover their own perceptions surrounding racial disparity, racial anxiety, and unconscious bias and modify their behaviors accordingly. It is this simple -and this complicated. Cancer does not discriminate, and neither should cancer care.

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.

Background Teclistamab, a first-in-class B-cell maturation antigen (BCMA) x CD3 bispecific antibody, gained US regulatory approval for relapsed or refractory multiple myeloma (MM) in Oct 2022 based on the MajesTEC-1 trial. Real-world patients (pts) with MM receiving teclistamab may differ from trial participants and be ineligible for clinical trials. We sought to evaluate patient profiles, treatment patterns, and outcomes in pts with MM who had high-risk cytogenetic abnormalities and received teclistamab in real-world settings in the US. Methods This was a retrospective US multi-site chart review. Participating physicians from Cardinal Health's Oncology Provider Extended Network abstracted data from electronic medical charts of eligible pts. Eligible pts with MM (≥18 years) initiated teclistamab on or after 10/25/22 and had a minimum 1-month follow-up at time of data abstraction (3/11/24); pts receiving teclistamab as part of a clinical trial were excluded. Pts were indexed on the first teclistamab dose. Characteristics and treatment history were captured during the pre-index baseline period; cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were captured during the step-up dosing (SUD) period; infections and clinical outcomes were captured during the follow-up period. Variables were analyzed descriptively. This analysis reports only on a subgroup of pts with observed presence of high-risk cytogenetics at initial MM diagnosis, defined as t(4;14), t(14;16), t(14;20), del(17p), gain(1q21), or amp(1q21) (‘high-risk‘). Results Thirty-eight high-risk pts were identified out of a total sample of 101 pts. Median age at teclistamab initiation was 66 years (range: 56-84); 63% male; 74% White, 18% Black, and 92% non-Hispanic; 53% had commercial and/or Medicare Advantage and 24% had Medicare Fee-For-Service insurance. Of the 38 pts with high-risk cytogenetics, 34 (90%) had an ECOG score 0-1 at time of teclistamab initiation and 23 (61%) had known stage III Revised International Staging System (R-ISS) at initial MM diagnosis. Relevant baseline comorbidities included anemia (32%) and renal impairment or failure (11%). 5 pts (13%) had an observed presence of extramedullary plasmacytoma and most (71%) had presence of lytic bone lesions on imaging at initiation. Pts had a median of 4 (range: 2-13) prior lines of therapy. Prior to teclistamab initiation, 5 pts (13%) had been treated with other BCMA-targeted therapies (all CAR-T therapy). Among pts with prior anti-BCMA therapy exposure, the median time from last anti-BCMA therapy to teclistamab initiation was 9.9 months (range: 4.0-41.8). During the SUD period, 14 (37%) pts experienced CRS, all grades 1-2, and 4 (11%) experienced ICANS, majority (75%) of which were grade 1-2. No pts discontinued teclistamab due to CRS or ICANS. At a median follow-up of 4.0 months (range: 0.9-15.1), 10 (26%) high-risk pts developed infections while on teclistamab. Immunoglobulin (IVIG) as primary prophylaxis for infection was administered to 17 (45%) of high-risk pts; of these pts, 15 (88%) reported an IgG level <400 mg/dL prior to IVIG administration. In this high-risk population, 2 (5%) pts were hospitalized and no pts discontinued teclistamab due to infections. The overall response rate (ORR) was 74% among pts with high-risk cytogenetics. The estimated progression-free survival (PFS) rate at 6 months post teclistamab initiation was 79%. Conclusion In this interim analysis of an ongoing, physician-led chart review study in the US, we evaluated a subset of pts who were observed to have high-risk cytogenetic abnormalities, a population broadly considered as hard-to-treat in the real world. Despite these high-risk features and heavy pre-treatment, high ORR and estimated 6-month PFS rate were observed in this real-world population. CRS and ICANS rates and severity appeared similar to existing literature on real-world teclistamab-recipients, with no pts discontinuing teclistamab due to CRS or ICANS. While updated results with longer follow-up are warranted, the preliminary findings suggest that teclistamab is an effective and safe treatment option for pts with high-risk relapsed/refractory MM.

171 Background: Serious mental illness (SMI), defined as a mental, behavioral, or emotional disorder resulting in serious functional impairment, that substantially interferes with or limits one or more major life activities, includes schizophrenia, bipolar disorder, and major depression. Patients with SMI and cancer have poor survival rates attributed to inequities in cancer care. Such patients are often diagnosed at an advanced stage and are more likely to have their cancer care interrupted. This study surveyed the general practices oncologists apply to integrate mental health and cancer care in their clinical practice. The study also surveyed perspectives on personalized collaborative care intervention to improve cancer outcomes in patients with SMI while identifying the barriers to adapting such intervention in clinical settings. Methods: In February and March 2024, US-based hematologists/oncologists convened at live meetings to discuss abstracts presented at the 2023 ASCO Quality Care Symposium. An online premeeting survey was used to collect participants’ demographics. Participants’ approach to mental health care for patients with cancer were captured via an audience response system during the live meetings. Responses were aggregated and analyzed using descriptive statistics. Results: Among 125 participants, 77% were community providers. The majority of participants (60%) reported frequently discussing mental health with their patients with cancer. Respondents support the mental health needs of their patients with cancer by utilizing in-house social workers (52%) or in-house counseling services (31%), or by referring to in-house clinical psychologist (40%) or an external psychiatrist (41%). They identified challenges to integrating mental health care into cancer treatment: lack of dedicated staff (54%), high patient volume (44%), and lack of available psychosocial tools (40%). Additionally, a subset of participants was asked about their perspectives on collaborative care intervention for cancer care of patients with SMI, and while most participants were encouraged, they also reported that mental health services should be coordinated primarily through either a psychiatrist (25%) or a social worker (25%). Interestingly, limited access to psychiatric care (78%) and lack of resources to screen patients for SMI (56%) were the primary barriers to adapting a personalized and collaborative care approach in the real-world setting. Conclusions: Participants were inclined to incorporate personalized mental health assessments into routine clinical care for their patients with cancer, however they face several barriers to implementation. Further research is needed to address those modifiable barriers and assess the impact of a personalized and collaborative care approach on timely diagnosis and mitigating inequities in cancer care to improve cancer outcomes in patients with SMI.