Inocencio, Timothy J.

e19504 Background: Initiation of bsAbs requires SUD with close monitoring, typically in IP settings, to mitigate early toxicities. As bsAb use expands, it is crucial to understand the financial viability for administering bsAbs, particularly non–PPS-exempt hospitals paid via a capitated, DRG-based method where costs may exceed payout. We compared net costs and payments for Medicare pts initiating bsAbs in the IP setting at non-PPS-exempt hospitals and explored cost variations for hospital characteristics and adverse events (AEs). Methods: Using Medicare FFS Parts A/B claims (10/25/21–10/20/24), pts ≥65 years with MM, IP bsAb initiation, and 12 mos continuous pre-index coverage were identified. Pts receiving other MM therapies <30 days post-index or treated in PPS-exempt hospitals were excluded. Hospital costs were estimated by applying revenue center–specific Medicare cost–charge ratios from CMS Hospital Cost Reports to IP facility charges. Outpatient (OP) bsAb costs were estimated using ASP/unit administered/wasted at the time of the claim. Costs for other OP services were estimated using revenue center–specific cost–charge ratios. Medicare payments were defined as total allowed amounts on IP and OP claims, and net cost as payments minus estimated costs. IP resource use and net cost recovery by academic vs nonacademic hospital, length of stay (LOS), and AEs were analyzed. Results: Of 3074 pts with a bsAb claim, 1129 met inclusion criteria. Mean IP LOS was 9 days (range 1–68). Hospital mean estimated IP cost/day for index hospitalization was $3963. Mean estimated costs for index hospitalization were $36964 per pt for IP SUD and $28366 for mean Medicare payments with a mean loss of $8598 per pt (median −$5616). Payments exceeded estimated costs on average by $2764–8149 for 1–4-day hospitalizations and roughly equal costs for hospitalizations at 5 days. For pts with LOS of 6–9 days and ≥10 days, payments were lower than costs by $6735 and $16659, respectively, suggesting a loss. For pts with subsequent OP administrations (74%) observable in this sample, cumulative payments and costs were assessed following the index hospitalization, mean cumulative longitudinal payments were ≥ cumulative costs within 2–3 mos. IP stay net losses were higher among pts with infection (−$6406 vs no infection), neutropenia (−$7006), and febrile neutropenia (−$10018). Payment patterns and estimated costs were similar across hospital types. Conclusions: Results suggest a large financial burden on non-PPS-exempt hospitals for IP-administered bsAb SUD. While shorter LOS for IP SUD generally did not result in financial losses, longer LOS was associated with disproportionately higher costs relative to payments. Care models (e.g. OP SUD) are key to manage initiation costs and ensure delivery of care for bsAbs remains financially sustainable.

Introduction: Oncologists increasingly recognize the need to evaluate the impact of cancer therapies on patients' time, known as “treatment-related time toxicity”, which is measured as the number of days of contact with the healthcare system (Gupta A et al. J Clin Oncol 2022). Current standard-of-care options for patients with TCE RRMM require frequent clinic visits for treatment administration. Reducing treatment-related time toxicity of treatment without compromising efficacy or safety may have an impact on patients' quality of life and influence treatment choice. BCMA-directed bispecific antibodies (BCMA bsAbs) provide a novel treatment option for TCE RRMM, with response-adapted dosing frequency allowing for extended dosing intervals for patients. The frequency of extended dosing intervals varies between BCMA bsAbs according to their prescribing information or pivotal trial protocol. The aim of this analysis was to evaluate the impact of BCMA bsAbs' extended dosing intervals on treatment-related contact (TRC) days corresponding to treatment administration as a component of time toxicity. Methods: An Excel-based longitudinal model was developed to quantify the number of TRC days experienced by patients with TCE RRMM within the healthcare system when receiving treatment with BCMA bsAbs (linvoseltamab, teclistamab, or elranatamab) over 1-2 years. TRC days included all planned treatment administration days. Model inputs were sourced from product labels or pivotal trial protocols for bsAbs, as well as the published literature. To allow for a comparison of total dosing regimens, it was assumed that patients continued receiving treatment throughout the study period with no discontinuation. Dosing intervals for each product during the first 6 months were once weekly (QW), except for linvoseltamab (QW for Weeks 1-14, then once every 2 weeks [Q2W] from Weeks 16-24, per Phase 2 trial protocol). The extended dosing interval for linvoseltamab was Q4W for patients reaching very good partial response or better at or after 24 weeks, and Q2W for both teclistamab patients who maintained a complete response (CR) or better for ≥6 months and for elranatamab patients who reached partial response or better at or after 6 months. Two switching scenarios were considered for teclistamab: an earliest possible switch (at Week 26), and a time-varying switch based on digitized time to CR data from MajesTEC-1 (Usmani SZ et al. ASCO 2023). Results were calculated to evaluate the difference in TRC days between the scenarios with and without extended dosing intervals for each treatment. Results: In the first year of treatment, the total number of TRC days with and without extended dosing intervals was lowest with linvoseltamab. TRC days with linvoseltamab were reduced from 33 to 26 days with extended dosing intervals. Next lowest was elranatamab (53 to 39 days), followed by teclistamab (54 to 41 days for earliest possible switch and 54 to 50 days with time-varying switching). Over 2 years, linvoseltamab had the lowest number of TRC days (59 to 39 days), followed by elranatamab (105 to 65 days) and teclistamab (106 to 67 days for earliest possible switch and 106 to 80 days with time-varying switching). Conclusions: Extended dosing intervals with BCMA bsAbs can substantially reduce time toxicity for patients with RRMM. Linvoseltamab had the lowest number of TRC days among BCMA bsAbs.

AbstractBackgroundA phase 2 cemiplimab study (NCT03132636) demonstrated a 24.1% objective response rate in patients diagnosed with metastatic basal cell carcinoma (mBCC) who were not candidates for continued hedgehog inhibitor (HHI) therapy due to intolerance to previous HHI therapy, disease progression while receiving HHI therapy, or having not better than stable disease on HHI therapy after 9 months. Here, health‐related quality of life (QoL) for this patient population is reported.MethodsAdult patients with mBCC were treated with intravenous cemiplimab at a dose of 350 mg every 3 weeks for 5 treatment cycles of 9 weeks/cycle then 4 treatment cycles of 12 weeks/cycle. Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life‐Core 30 (QLQ‐C30) and Skindex‐16 questionnaires at baseline and Day 1 of each cycle. Across Cycles 2 to 9, the overall change from baseline was analyzed using a mixed model with repeated measures. Responder analyses determined clinically meaningful improvement or deterioration (changes ≥10 points) or maintenance across all scales.ResultsPatients reported low symptom burden and moderate‐to‐high functioning at baseline. Maintenance for QLQ‐C30 global health status (GHS)/QoL and across all functioning and symptom scales was indicated by overall mean changes from baseline. Clinically meaningful improvement or maintenance was reported at Cycle 2 for GHS/QoL (77%), functioning scales (77% to 86%), and symptom scales (70% to 93%), with similar proportions of improvement or maintenance at Cycles 6 and 9, excluding fatigue. On the Skindex‐16, clinically meaningful improvement or maintenance was reported across the emotional, symptom, and functional subscales, in 76%–88% of patients at Cycle 2, which were generally maintained at Cycles 6 and 9. Overall mean changes from baseline showed maintenance across these subscales.ConclusionsThe majority of patients treated with cemiplimab reported improvement or maintenance in GHS/QoL and functioning while maintaining a low symptom burden.

e23310 Background: Chimeric antigen receptor T-cell therapy (CAR T) is FDA-approved in pts with triple-class exposed (TCE) relapsed/refractory (RR) MM after four or more prior lines of therapy (LOTs). Real-world access to CAR T remains challenging due to manufacturing capacity, financial barriers, and pt fitness. Pts with certain pre-existing comorbidities (e.g., central nervous system disease, heart disease, secondary malignancies) are commonly excluded from clinical trials, including those investigating CAR T. The objective of this study was to identify the factors associated with the use of CAR T in pts with TCE RRMM to better understand the unmet need in this population. Methods: We conducted an observational cohort study using Medicare fee-for-service data; each pt in the CAR T intention-to-treat (ITT) population between 2021 and 2023 was matched to three non-CAR T pts, without replacement. Pts were eligible if they had an initial MM diagnosis, were continuously enrolled, were TCE, and did not receive treatment in a clinical trial. The index date was the ITT date. Baseline characteristics included age, sex, race/ethnicity, census region, three comorbidity indexes (Charlson, Elixhauser, CMS hierarchical condition categories [HCCs]), a claims-based frailty index (CFI), and dual enrollment in Medicare and Medicaid (as a proxy to social economic status [SES]). Logistic regression was used to derive odds ratios (ORs) and 95% confidence intervals (CIs) comparing the characteristics of CAR T vs non-CAR T pts. Results: Seventy-three ITT CAR T pts (nine underwent apheresis but did not receive CAR T) were matched to 219 non-CAR T pts by LOT and index year. Matched pts were treated with varied standard regimens (daratumumab-containing: 63%). Median prior LOTs were similar in the two cohorts (8; range 2–13). Median time from MM diagnosis to index date was 44.6 and 51.9 months for CAR T and non-CAR T pts, respectively. Compared with non-CAR T pts, pts in the CAR T population were younger (aged < 75 years: 59% CAR T vs 36% non-CAR T), less frail (mean CFI: 0.18 vs 0.20) and had higher SES (without dual enrollment in Medicare and Medicaid: 96% vs 81%), but were similar in terms of sex, region, and race/ethnicity. Variation in individual comorbidity prevalence was observed between CAR T and non-CAR T pts. In a multivariable regression analysis, factors strongly associated with lower odds of CAR T use included age ≥75 years (OR 0.29; 95% CI 0.16–0.53), comorbidities (lung/other severe cancers [OR 0.39; 95% CI 0.20–0.74] and chronic obstructive pulmonary disease [OR 0.32; 95% CI 0.10–0.99] defined by HCCs), and SES (OR 0.09; 95% CI 0.02–0.37). Conclusions: Older age, certain comorbidities, and lower SES are associated with lower odds of receiving CAR T in real-world pts with TCE RRMM, demonstrating an unmet need for more accessible and effective treatment options with acceptable safety profiles for these pts.

e23309 Background: BCMA-directed T-cell–engaging therapies have been introduced into clinical practice for the treatment of TCE RRMM. While efficacious, such treatments are associated with safety considerations such as cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and serious infections. These treatments also vary in reported efficacy, administration processes, and hospitalization requirements. The aim of this study is to quantify patient preferences and tradeoffs regarding these attributes. Methods: A discrete choice experiment (DCE) was designed to elicit preference weights corresponding to seven attributes related to efficacy (objective response rate [ORR], overall survival [OS]), safety (all-grade CRS, all-grade ICANS, serious infections) and treatment procedures (treatment administration, hospitalization requirements). Attribute levels were based on plausible ranges of potential values. Patients in the United States (US) with a physician-confirmed diagnosis of TCE RRMM were recruited. Pre-test interviews with patients were conducted and the final survey deployed online in 2023. A random-parameters logit model was used to estimate preference weights. Conditional relative importance (CRI) was calculated to rank the relative importance of each attribute. The minimum acceptable benefit (MAB) and maximum acceptable risk (MAR) were calculated to estimate the tradeoffs between efficacy and safety attributes. Results: The sample included 200 respondents (mean [standard deviation] age: 61 [6.4] years; 43% female; 46% White; 10% African American). A total of 197 participants reported having responded to prior treatment, of whom 195 had relapsed or become refractory. In the DCE, a 24-month increase in OS was found to be the most important attribute, with a CRI of 32.0%. Next most important were avoiding a 60% risk of serious infection (CRI 17.3%), avoiding 14-day hospitalization requirements (CRI 15.0%), and a 38% increase in ORR (CRI 13.7%). A treatment that could be started immediately and administered weekly or up to every 4 weeks was preferred over a CAR T-like procedure with a waiting period. Fewer initial hospitalization days was significantly preferred over more hospitalization days. The MABs for OS when the risk of serious infection was increased from 20% to 60%, CRS from 40% to 95%, and ICANS from 3% to 20% were 24.2, 17.1, and 18.0 months, respectively. When OS was increased from 12 to 36 months, the estimated MARs for serious infections, CRS, and ICANS were > 60%, > 95%, and > 20%, respectively. Conclusions: This study highlights US patient preferences regarding treatment attributes for TCE RRMM. Treatment benefits and risks and the mutual tradeoffs considered by patients should be evaluated when developing and selecting therapeutic approaches.