Dosing Patterns and Early Safety and Effectiveness Outcomes in Patients with Multiple Myeloma Treated with Teclistamab in the Community Setting

Abstract

Introduction: Teclistamab, a novel BCMA x CD3 bispecific antibody, is indicated for the treatment of triple-class-exposed relapsed/refractory multiple myeloma (MM). Initiation of teclistamab includes a step-up dosing (SUD) phase followed by continuous weekly or bi-weekly treatment doses. While teclistamab SUD has been initiated primarily in academic medical centers following regulatory approval in October 2022, expanding SUD to community practices provides a means to improve patient access to treatment. This study explored the feasibility of community-based teclistamab administration by characterizing teclistamab SUD and continuous treatment dosing patterns, as well as early effectiveness and safety outcomes in a real-world cohort of MM patients treated in community practices. Methods: The Integra Connect (IC) database includes linked electronic health records (EHR) and claims data from 30 community-based oncology practice networks across the United States. We conducted a retrospective study of adult patients with MM who received ≥1 treatment dose (1.5mg/kg) of teclistamab at one of the practices included in IC; a subgroup of patients who completed SUD in community practices was identified. To standardize the measurement of follow-up time for all patients, the index date for time-to-event outcomes was anchored to the first observed treatment dose of teclistamab. Patients were included in the final study sample if their first recorded dose was after October 25, 2022 (FDA approval date) and before April 1, 2024. Demographics, clinical characteristics, step-up and continuous dosing patterns, and rate and severity of cytokine release syndrome (CRS) were reported descriptively. CRS rate and severity were identified using ICD-10 codes linked to patient records during the SUD period. Duration of therapy (DoT) and time to less frequent dosing (LFD, biweekly or less often) were reported using the Kaplan-Meier estimator. Results: 108 patients with MM who received at least one treatment dose of teclistamab in the community setting were identified (median age 65; 86% were White; 70% had Medicare/Medicaid; 28% had commercial insurance; 19% previously received another BCMA-targeted therapy). Most patients (n=79, 73%) did not receive any step-up doses in the community setting, indicating a referral history for SUD elsewhere; 25 of the 29 patients who received at least one step-up dose in the community setting completed the entire SUD process in the community setting. Median follow-up was 5 months (range: 0.3-15 months) after the first treatment dose of teclistamab. Among all patients who received at least one full dose of teclistamab in the community setting, 94% (n=101) started with weekly doses of teclistamab, and 39% (n=42) received biweekly dosing over the course of follow-up with a median time to LFD of 5.5 months from the first treatment dose. At data cut-off, 25% (n=27) of patients had discontinued teclistamab; median DoT was 10.3 months. Among the subset of patients who completed SUD in the community setting, 92% (n=23) completed per a label-recommended dosing schedule with an interval of 2-4 days (Day 1-4-7, n=10; Day 1-3-5, n=6; Day 1-4-6, n=3; Day 1-5-7, n=2; Day 1-5-8, n=2); 98% of all observed step-up doses were administered in the inpatient setting. 32% (n=8) of patients who completed SUD in the community setting had at least one record of CRS occurrence during the SUD period, all of which were either grade 1 or grade 2; median time to CRS onset among these was on day 4 of the SUD period. Conclusions: Results of this real-worldstudy suggest that community-based teclistamab administration is feasible for both SUD and continuous management of patients with RRMM. One-quarter of community-treated teclistamab patients completed the entire SUD process in the community setting, with over 90% following a PI-recommended dosing schedule without delay. Early results on safety and effectiveness were promising; CRS was observed in approximately 1/3 of patients completing SUD in the community setting and confined to grade 1 and 2 events, and median DoT was over 10 months. While further research using linked academic and community practice data is needed to fully understand the continuum of care for community-treated patients, findings support community-based treatment as a means to improve access to novel treatments and continuity of care for patients with relapsed/refractory MM.