SUMMARY

• Summarized below are real-world, observational and retrospective studies and registries which evaluated the outpatient (OP) administration of TECVAYLI in adult patients with multiple myeloma (MM).^1-5
• Other relevant literature on the evaluation of bispecific antibody (BsAb) administration and remote patient monitoring (RPM) are included below for your reference.^6-12

Real-world data

Chen et al (2025)⁵ presented a structured approach to shift TECVAYLI step-up dosing (SUD) from the inpatient (IP) to OP setting, and from academic to community centers.

Study Design/Methods

• A TECVAYLI Working Group was initiated to adapt TECVAYLI SUD protocols from IP to OP setting.
• Patients in the pilot cohort were enrolled at academic center to evaluate the protocols, with sequential patient reviews focusing on logistics and safety (treatment metrics, toxicity management, and resource utilization).
• Safety concerns and inefficiencies led to process refinements, followed by re-testing in subsequent patients.
• Key insights and best practices were consolidated into a handbook to support implementation in community settings.
• Protocol development overview:
  • First step: review of trial data and institutional experience
  • Second step: empirical OP guidelines were developed based on cytokine release syndrome (CRS) kinetics. Daily clinical visits were mandated throughout the SUD period and for up to 2 days following the first full treatment dose (continuous monitoring over 7-9 days).
    • Patients and caregivers were provided with home-monitoring tools.
    • Temporary relocation within a one-hour radius of the treatment facility was required during OP SUD, consistent with OP chimeric antigen receptor (CAR) T-cell therapy protocols.
    • A flex bed was made available for after-hours admissions to avoid emergency department utilization.
    • Guidelines for OP CRS management (treatment criteria, admission criteria, duration of monitoring after tocilizumab, delay dosing, and IP/OP disposition after delays) were established using the product monograph and trial experience.
    • Prophylactic tocilizumab was not utilized; instead, “early” implementation was initiated at first onset fever (grade 1 CRS).
  • Third step: all the patients were treated using empiric guidelines. The TECVAYLI Working Group convened 1-2 times weekly to review patient outcomes and refine protocols based on learnings.

Results

Patient Demographics and Characteristics

• A total of 13 patients were included in the pilot cohort.
  • Median age was 67 years (range 54-82); patients had a median of 4 prior lines of therapy (range 3-10), with 100% being triple-class refractory. Prior BCMA-directed therapy was documented in 5 patients (CAR-T therapy, n=1; belantamab mafodotin, n=2; BsAb, n=2). High-risk cytogenetics [t(4;14), t(14;16), del(17p)] were present in 5.4% of patients. Comorbidities were common, with serum creatinine levels ranging from 49-396 µmol/L (median 84 µmol/L), and one-third of patients had ≥3 active comorbidities. Cytopenias were frequent, with 3 patients requiring transfusion support.

Safety - CRS Incidence and Management in the OP Setting

• CRS was reported in 46% of patients (n=6), all grade 1 (fever only), with onset of 1-2 days post SUD-2. All grade 1 CRS events were resolved without progression.
• No CRS events were reported on the day of dosing.
• Of the 6 patients with grade 1 CRS, 5 received a single dose of tocilizumab, and 1 patient received acetaminophen alone. Time to defervescence ranged from 1.5-4.2 hours.
• Four patients were treated and discharged home from the day unit; 2 patients required overnight hospital monitoring but were discharged the next day without intervention.
• CRS management: scheduling TECVAYLI SUD on Monday-Wednesday to avoid weekend intervention for CRS events. Monitoring patients for 4 hours post-tocilizumab to enable safe discharge without admission. Early treatment at fever onset may prevent escalation to higher needs, thus avoiding the need for prophylactic tocilizumab.

Sandahl et al (2024)⁴ published a retrospective, observational study using Mayo Clinic’s electronic medical records (EMRs) evaluating safety outcomes and healthcare resource utilization during SUD in patients with relapsed/refractory multiple myeloma (RRMM) who received OP administration of TECVAYLI.

Study Design/Methods

• Adult patients with RRMM who received TECVAYLI at any of 3 Mayo Clinic locations (Rochester, MN; Phoenix/Scottsdale, AZ; and Jacksonville, FL) between October 26, 2022, and October 31, 2023, were included. Those who received TECVAYLI in a clinical trial setting were excluded.
• All data that were evaluated in this study were collected during routine clinical care at the 3 Mayo Clinic locations.

Results

Patient Demographics and Characteristics

• At data cutoff, 65 patients across the 3 Mayo Clinic locations received ≥1 TECVAYLI dose; among these, 89.2% of patients (n=58) were initiated on TECVAYLI SUD directly in an OP setting. See Figure: Patient Attrition for additional details.
• Select baseline demographics of the study population are presented in Table: Baseline Characteristics of Patients Who Received ≥1 TECVAYLI Dose.

SUD Pattern and Dosing Schedule

• Of the 59 patients who received complete SUD at data cutoff (irrespective of the administration setting), 54.2% of patients (n=32) completed SUD in 3-day dose intervals (days 1, 4, and 7), 5.1% of patients (n=3) completed SUD in 2-day dose intervals (days 1, 3, and 5), and 40.7% of patients (n=24) completed SUD in other dosing intervals (days 1, 4, and 6; days 1, 3, and 6; and other dosing schedules that differed from the 2- and 3-day intervals).
• The median time between the first and third step-up doses was 6 days (interquartile range [IQR], 6-7).
• At a median time to switching of 3.1 months (IQR, 1.4-6.6), 43 patients received ≥2 post-SUD treatment doses; of these, 11.6% of patients (n=5) switched from a weekly (QW) to every other week (Q2W) dosing schedule.

Safety and Healthcare Resource Utilization During SUD

• Patients who underwent OP TECVAYLI SUD and developed CRS of any grade were admitted to the hospital for treatment per Mayo Clinic’s treatment protocol.
• CRS and neurotoxicity outcomes in patients with complete SUD are summarized in Table: CRS and Neurotoxicity Outcomes in Patients With Complete SUD.
• Of the 16 patients with previous exposure to other B-cell maturation antigen (BCMA)-targeted therapies who completed SUD irrespective of the administration settings, 31.3% of patients developed CRS.

Clinic Time

• Clinic time information was available for 99% of TECVAYLI doses; of these, 60% of step-up doses required <1 hour of clinic time from TECVAYLI administration to patient checkout.
• After SUD, the clinic time for TECVAYLI treatment dose administration decreased to <30 minutes for 82% of doses.

Yanovsky et al (2023)¹ evaluated the safety of OP TECVAYLI administration through a retrospective review of the toxicity outcomes in patients treated in the OP TECVAYLI program at Fox Chase.

Study Design/Methods

• Eligible patients were mandated to remain within 1 hour proximity to Fox Chase with a caregiver during the observation period (days 1-10).
• Education on CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) was provided to both patients and caregivers.
• TECVAYLI was administered on days 1, 3, and 8.
• The safety monitoring protocol included daily evaluation in the OP clinic, home monitoring of vital signs, and 8 PM physician phone call on days 1-5 and 8-10, within 48 hours of each step-up dose.
• Complete blood count, comprehensive metabolic panel, C-reactive protein (CRP) level, and ferritin level were monitored at each visit.
• Patients with any-grade CRS/ICANS were admitted for observation and management.

Results

• Between December 2022 and May 2023, 18 patients (median age, 66 years [range, 46-81]) completed OP TECVAYLI SUD.

CRS Incidence and Management

• Twelve patients (66.7%) did not have CRS/ICANS. Five patients (27.8%) had grade 1 CRS, of whom 1 (5.6%) had concurrent grade 1 ICANS, and 1 (5.6%) patient had grade 2 CRS.
• Of the 6 CRS events, 3 (50%) occurred after the first dose and 3 (50%) after the second dose.
• Of the 6 patients with CRS, 5 received 1 dose of tocilizumab, and the patient with concurrent ICANS also received dexamethasone, with prompt resolution of symptoms.
• All patients completed SUD with no recurrent CRS/ICANS.

Hebraud et al (2023)² presented a monocentric experience evaluating the characteristics and outcomes of patients with MM treated with TECVAYLI in an OP setting, including during the SUD phase.

Study Design/Methods

• Patients were eligible for the OP administration of TECVAYLI if they maintained a general condition with no active infection, with no high tumor burden or very rapidly progressing disease, and who stayed within 0.5 hours proximity to the treatment site for 48 hours after each step-up dose and after the first full dose.
• Patients meeting the eligibility criteria received specific at-home monitoring for 15 days, which included blood pressure, oxygen saturation (SpO₂), and body temperature measurements by a homecare nurse twice a day.
• Patients and caregivers were given a blood pressure monitor and an oximeter and trained to self-monitor CRS.
• Emergency use of oral dexamethasone was available at home, along with hospital’s 24-hour contacts, in case grade 2 CRS or any other complication occurred.

Results

• The data cutoff was November 10, 2023.
• Of the 18 patients who completed TECVAYLI SUD in the French Early Access program, 9 (50%) were exclusively dosed in an OP setting.
• Following premedications (including dexamethasone until day 8), dose escalation was aligned with Food and Drug Administration (FDA) and European Medicines Agency (EMA) recommendations. All patients received TECVAYLI step-up doses on days 1 and 4, and the first full dose on day 8. At-home monitoring was carried out by a nurse twice a day until day 15.
  • All patients received systematic primary prophylaxis with antibiotic and antiviral medications (amoxicillin or equivalent, cotrimoxazole or equivalent, and valaciclovir), as well as polyvalent immunoglobulins (administered subcutaneously once a week at home).
• Median age of patients at TECVAYLI initiation was 76 years (range, 45-82). The medium number of prior lines of therapy before TECVAYLI initiation was 4 (range, 3-7).
  • One patient who received TECVAYLI less than a month before cutoff was not evaluable for response.

Efficacy

• All 8 evaluable patients achieved a very good partial response or better (≥VGPR).
• One patient (who had a seventh relapse of MM) had progression of disease after 88 days and received 1 subsequent line; this patient eventually died of progression.
• All the other patients remained under treatment at a median follow-up at 88 days at the data cutoff.

Safety

• Grade ≥2 infections were reported in 2 patients before day 30; 1 patient required hospitalization, and both patients had a complete recovery.
• CRS was reported in 3 patients (grade 1, n=2 [managed with dexamethasone 10 mg at home], grade 2, n=1 [managed with dexamethasone and tocilizumab injection]).
• No ICANS was reported.
• One patient required an unplanned admission of 10 days to manage both grade 2 CRS and cytomegalovirus (CMV) reactivation, which occurred simultaneously.
• There were no toxicity-related deaths.

Bansal et al (2023)³ presented a retrospective analysis of patients who received FDA-approved CAR-T or TECVAYLI in the hospital-based OP unit at Mayo Clinic, Rochester between October 2020 and April 2023.

Study Design/Methods

• RPM was done from day 0 to at least day 30.
  • Scheduled entry was recorded at least 4 times a day which included vital sign and mental status assessment.
  • Unscheduled entry was recorded as needed based on patient condition/new symptoms.
  • Alert was generated routinely, on a semi-urgent basis, an urgent basis, or an emergency basis.
  • Days 1-30, daily visits occurred the first 7 days followed by visits based on clinical need and RPM.
  • Admission criteria included the following: fever ≥38.3°C, unstable vital signs, elevated CRP, new onset neurologic symptoms, and clinical concern.

Results

• Twenty-three patients (median age, 67 years [range, 38-81]) received TECVAYLI, with a total of 155 injections between IP dosing (3/155 injections [2%]) and OP dosing (152/155 injections [98%]; 132/152 (87%) were never admitted).
• The median number of prior lines of therapy recorded was 5 (range, 3-14), and 9 patients (39%) had high-risk cytogenetics.

Safety

• Twenty patients were admitted to the hospital, of whom 18 patients (90%) were admitted during the SUD period. The average LOS for each admission was 2 days (range, 0-12). See Table: Summary of Hospital Admission.
• Grade 1 CRS was reported in 14/15 patients (93%), and grade 4 CRS was reported in 1/15 patients (7%).
  • CRS was managed via steroids in 14/15 patients (93%), with 1/15 patients (7%) receiving steroids + tocilizumab.
• No deaths were reported due to OP management.

• Six patients received TECVAYLI via hospital-based OP dosing and enrolled in RPM.
  • The median number of RPM days was 14 (range, 10-17).
  • The median number of entries recorded was 411 (range, 193-710).
  • The median percentage of alerts recorded was 2% (range, 0-4).

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 14 October 2025.