TECVAYLI - Step-up Dosing - Real-world Evidence

SUMMARY

• Summarized below are key real-world, observational and retrospective studies and registries which evaluated the step-up dosing (SUD) schedule of TECVAYLI, specific to the timeframe between doses or length of stay (LOS), in adult patients with multiple myeloma (MM).^1-7 
  • Ailawadhi et al (2025)⁷ presented a retrospective analysis of Medicare claims data that described healthcare resource utilization (HCRU) among Medicare patients with relapsed/refractory multiple myeloma (RRMM) who initiated TECVAYLI in the United States (US).
  • Varga et al (2025)⁶ presented a real-world, retrospective chart review study evaluating patient characteristics, safety outcomes, and HCRU during outpatient (OP), inpatient (IP), and hybrid (HY) SUD of TECVAYLI or TALVEY in patients with RRMM.
  • Abrams et al (2025)⁵ presented the outcomes of a retrospective, observational study of patients with RRMM who initiated TECVAYLI or TALVEY with SUD in OP, IP, or HY settings within a large US community oncology network.
  • Tan et al (2025)^3,4 reported a retrospective, observational study that evaluated patient characteristics, LOS during the SUD and the real-world incidence and management of cytokine release syndrome (CRS) in patients with MM who had initiated TECVAYLI.
  • Banerjee et al (2023)² presented a retrospective, observational analysis that evaluated patient profiles and HCRU during the SUD period and the incidence of real-world CRS in patients with MM who had received TECVAYLI.
  • Banerjee et al (2023)¹ presented a real-world, retrospective analysis of Acentrus MM EMRs that evaluated the dosing patterns, HCRU, and the early safety outcomes during TECVAYLI SUD among US patients receiving TECVAYLI.
• Additional data in smaller sample sizes (<100) have been identified and are included below for your reference.^8-12 

PRODUCT LABELING

• TECVAYLI (teclistamab-cqyv) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/TECVAYLI-pi.pdf.
• TALVEY (talquetamab-tgvs) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/TALVEY-pi.pdf.

Real-world data

Medicare Claims-Based HCRU Following TECVAYLI Initiation

Ailawadhi et al (2025)⁷ presented a retrospective analysis of Medicare claims data that described HCRU among Medicare patients with RRMM who initiated TECVAYLI in the US.

Study Design/Methods

• The study used a 100% sample of fee-for-service Medicare enrollment and medical claims data (parts A and B) collected from October 25, 2021, to September 30, 2024 (study period).
• Eligible patients had at least 1 MM diagnosis and at least 1 TECVAYLI claim at least 30 days before the end of the study period.
• Continuous Medicare medical benefits enrollment was required during the 12 months before and including the first TECVAYLI claim (index date).
• Other key eligibility criteria were:
  • Index date on or after the availability of both IP and OP procedure codes for TECVAYLI
  • Absence of MM treatment claims other than TECVAYLI or a corticosteroid within 30 days after the index date
  • Patients with the first TECVAYLI administration in the OP setting received a dose consistent with the first step-up dose
  • Age ≥65 years at the index date
• The follow-up period for each patient was defined as the time from the index date to the first occurrence of death, end of continuous enrolment, or end of the study period.
• Treatment initiation setting was determined based on the setting of the first TECVAYLI claim (IP or OP).
  • In the IP cohort, SUD completion was defined by ≥1 OP administration of a full TECVAYLI dose (ie, not an SUD) ≥10 days after the index date.
  • In the OP cohort, SUD completion was defined by ≥2 OP administrations of TECVAYLI at a full treatment dose.

Results

Patient Characteristics

• Of the 2185 patients with ≥1 TECVAYLI claim during the study period, 1373 met all eligibility criteria.
• Patients had a mean (median) age of 75 (74) years at the index date, and 49% were female.
• The median duration of follow-up was 7.0 months (range, 0.2-22.7).

HCRU

• Overall, 87% of patients initiated TECVAYLI treatment in the IP setting.
  • The mean LOS for the index hospitalization was 9.3 days.
• Among patients who received TECVAYLI in the OP setting, 41% were hospitalized within 1 month of treatment initiation.
• In the overall population, the Kaplan-Meier estimated median TECVAYLI treatment duration was 6.1 months, and SUD was completed by 87% of patients.
• During TECVAYLI treatment, patients had a mean (median) of 0.72 (0.32) hospitalizations per patient per month (PPPM) and 6.4 (5.8) hospital outpatient or physician office visits PPPM.

SUD Patterns Across Care Settings in the eMMpower Consortium

Varga et al (2025)⁶ presented a real-world, retrospective chart review study evaluating patient characteristics, safety outcomes, and HCRU during OP, IP, and HY SUD of TECVAYLI or TALVEY in patients with RRMM.

Study Design/Methods

• Patients were identified from the eMMpower consortium (PA-322), an ongoing, multicenter, longitudinal, real-world retrospective chart review study of patients with MM in the US. Data were collected through March 31, 2025.
• Eligible patients were adults with RRMM who initiated TECVAYLI or TALVEY monotherapy following US Food and Drug Administration (FDA) approval of each agent. Patients who received TECVAYLI or TALVEY as part of a clinical trial, through an expanded access program, or as bridging therapy before chimeric antigen receptor T-cell (CAR-T) therapy were excluded.
• The index date was defined as the date of the first dose of TECVAYLI or TALVEY.
• Patients were followed until the earliest occurrence of the end of the SUD period (defined as 2 days after the last SUD dose), the last documented patient encounter, initiation of the next line of therapy, or death.
• Patients were categorized into 3 cohorts based on the SUD administration setting:
  • OP: patients had no planned hospitalizations during the SUD period.
  • IP: patients had ≥1 planned hospitalization that encompassed all SUD administrations.
  • HY: patients had ≥1 planned hospitalization during the SUD period, but not all SUD administrations occurred during hospitalization.

Results

Patient Demographics and Baseline Characteristics

• A total of 221 patients were included in the study.
• Patient demographics and clinical characteristics were evaluated as of the index date. and are presented in Table: Patient Characteristics at Index.
• The median duration of follow-up after the index date was 4.8 months (IP, 9.9 months; HY, 7.9 months).
• All IP TECVAYLI SUD patients completed SUD, except 1 with ongoing SUD at chart abstraction.

Hospitalizations

• Patterns of HCRU during SUD are presented in Table: Hospitalization During the SUD Period by SUD Setting.

Safety

• Details pertaining to CRS are presented in Table: CRS Outcomes During and Following the SUD Period.
  • No grade 4 or grade 5 CRS events were reported during this period.
  • Tocilizumab was administered for CRS management in 47.7% of patients in the IP SUD cohort and 30.9% of patients in the HY SUD cohort; no patients in the OP SUD cohort received tocilizumab.
  • One patient in the HY SUD cohort received prophylactic tocilizumab for CRS.
• Overall safety outcomes are summarized in Table: Safety Outcomes.

SUD Patterns Across Care Settings in the OneOncology Network

Abrams et al (2025)⁵ presented the outcomes of a retrospective, observational study of patients with RRMM who initiated TECVAYLI or TALVEY with SUD in OP, IP, or HY settings within a large US community oncology network.

Study Design/Methods

• Patients were identified from the OneOncology network, a large consortium of community oncology practices across the US.
• Eligible patients included adults (≥18 years of age) who received TECVAYLI after October 25, 2022. Data were collected through February 28, 2025.
• Data were extracted from patient charts and electronic medical records (EMRs), including clinical characteristics, treatment history, SUD patterns, adverse events, and HCRU.
• Treatment followed US prescribing information guidelines, with pre-treatment and prophylactic measures administered at the physician’s discretion.
• Patients were categorized into 3 cohorts based on the SUD administration setting:
  • OP: patients received all SUD doses in an OP setting. Grade 1 CRS was managed with acetaminophen or dexamethasone at the physician’s discretion, while grade ≥2 CRS warranted hospitalization.
  • IP: patients received all SUD doses in an IP setting.
  • HY: patients began SUD in an OP setting, followed by a 48-hour IP observation period.

Results

Patient Demographics and Baseline Characteristics

• A total of 120 patients were included in the study, of whom 84 received TECVAYLI (OP cohort, n=13; IP cohort, n=42; HY, n=29).
• The median number of prior lines of therapy (LOTs) for TECVAYLI-treated patients was 4 across all settings.

SUD

• All patients in the OP cohort successfully completed SUD.
• The most frequent SUD schedule for TECVAYLI was 1-3-5 in the OP (62%) and HY (38%) cohorts, and 1-4-7 in the IP cohort (48%).

Safety

• CRS and immune effector cell-associated neurotoxicity syndrome (ICANS) during SUD was reported in patients who received either TECVAYLI or TALVEY (OP, n=23; IP, n=54; HY, n=43).
  • CRS during SUD was reported in 61% of patients in the OP cohort (n=14), 50% in the IP cohort (n=27), and 63% in the HY cohort (n=27).
    • CRS events were grade 1 or 2 across all cohorts.
    • No recurrent CRS events were reported in the OP cohort; recurrence rates were 7% in the IP cohort and 26% in the HY cohort.
  • ICANS during SUD was reported in 4% of patients in the OP cohort (n=1), 6% in the IP cohort (n=3), and 14% in the HY cohort (n=6).
    • The highest grade of ICANS was 2 in the OP and HY cohorts, and 4 in the IP cohort.
    • No recurrent ICANS events were reported in the OP or IP cohorts; recurrence rate was 5% in the HY cohort.
• No patients discontinued TECVAYLI due to CRS; 1 patient in the HY cohort discontinued TECVAYLI due to ICANS of unknown grade.
• A total of 70% of patients in the OP cohort, who received either TECVAYLI or TALVEY, completed the SUD phase without requiring hospitalization. The median hospital stay was 4 days for 5 patients in the OP cohort who developed grade 2 CRS and were hospitalized.
• Tocilizumab and steroids were administered for the management of CRS and ICANS, respectively.

SUD Patterns and LOS in the Premier Healthcare Database

Tan et al (2025)^3,4 reported a retrospective, observational study that evaluated patient characteristics, LOS during the SUD and the real-world incidence and management of CRS in patients with MM who had initiated TECVAYLI.

Study Design/Methods

• Patients with ≥1 hospital encounter involving TECVAYLI administration were identified using the Premier Healthcare Database (which represents approximately 1 in 5 IP hospital stays in the US), an all-payer US hospital administrative database.
• Eligible patients included adults (≥18 years of age) with MM who had hospital encounters (including IP admissions and OP encounters) and received ≥1 TECVAYLI administration between November 1, 2022, and September 21, 2023, and were not part of a clinical trial.
• The date of the earliest hospital encounter for the first TECVAYLI 30 mg/3 mL vial was defined as an index date.
• Patients were classified as having a complete SUD schedule if they received the 2 step-up doses (0.06 mg/kg and 0.3 mg/kg) followed by the first full treatment dose of 1.5 mg/kg.
• The accuracy and completeness of SUD schedules were assessed using an algorithm that evaluated the TECVAYLI vials administered and time of administration.
  • The algorithm required an initial vial size of 30 mg/3 mL for the initial SUD, followed by a 153 mg/1.7 mL vial as the final dose in the SUD period.
• CRS-related outcomes during the SUD period were analyzed only in patients who completed the SUD period.
  • CRS was identified via International Classification of Diseases, 10^th Revision, Clinical Modification (ICD-10-CM) codes and an algorithm based on related symptoms and treatment codes.

Results

Patient Demographics and Baseline Characteristics

• A total of 413 patients were included in the study.
• Patient demographics, clinical characteristics, and comorbidities were evaluated as of the index date. Baseline characteristics are presented in Table: Baseline Characteristics of Real-World Patients Treated With TECVAYLI.

SUD

• TECVAYLI was administered to 96.4% of patients in an urban hospital.
• Out of 302 patients who completed the SUD period by the data cutoff, 276 (91.4%) received the full course of SUD during a single IP admission, 14 (4.6%) in OP settings, and 3 (<1%) were treated across both IP and OP settings. See Table: Real-World SUD Pattern Among Patients Who Completed SUD for additional details.
• Out of 276 patients who completed TECVAYLI SUD during a single IP admission, 243 (88.0%) were administered TECVAYLI on the first day of hospitalization, while 44 (15.9%) received it on or after the second day of hospitalization.

CRS Incidence and Severity

• Of the 302 patients with a completed SUD period as of the data cutoff, 96 (31.8%) were diagnosed with CRS.
• Details pertaining to CRS are presented in Table: CRS Incidence and Severity Among Patients Who Completed TECVAYLI SUD.
• Incidence and management of CRS were assessed from the index date through the end of the SUD period.

Adverse Event Management

• Adverse event management is detailed in Table: Adverse Event Management Among Patients Who Completed TECVAYLI SUD.
• Medication administered during the SUD period was assessed overall and in relation to TECVAYLI SUDs: ≥1 day prior, same day, and ≥1 day post-TECAVYLI SUD administration.

HCRU and LOS During SUD in the ARMMRD Registry

Banerjee et al (2023)² presented a retrospective, observational analysis that evaluated patient profiles and HCRU during the SUD period and the incidence of real-world CRS in patients with MM who had received TECVAYLI.

Study Design/Methods

• The study utilized data from the ARMMRD registry, sourced from STATinMED RWD insights, encompassing all-payer claims data that spanned approximately 87% of the nationally insured population in the US, spanning from January 1, 2014, to July 31, 2023.
• Adult patients (≥18 years of age) with MM who had ≥1 commercial TECVAYLI claim within the ARMMRD registry during the identification period (October 26, 2022, to July 31, 2023) were included in this study.
• The index date was determined as the earliest OP claim for a TECVAYLI 30 mg/3 mL vial or the admission date of the earliest hospitalization claim containing TECVAYLI.
• Patients who had received TECVAYLI on or before the approval date were excluded from the analysis.
• A claim-based algorithm was employed to identify patients with a complete SUD period based on the following criteria:
  • Patients who have had ≥1 IP admission or ≥1 OP claim for a TECVAYLI 30 mg/3 mL vial; the earliest admission date (if IP) or claim date (if OP) was defined as the start date of the SUD period.
  • All IP or OP claims for TECVAYLI with a <5-day gap between claims within a 21-day continuous enrollment period were rolled up as part of the SUD period. If the index claim was an OP claim, an additional OP claim for a TECVAYLI 153 mg/1.7 mL vial was required.
  • The end date of the SUD period was the discharge date, if the last encounter was an IP admission, or claim date +4 days, if the last encounter was an OP claim for a 153 mg/1.7 mL vial.

Results

• In total, 182 patients with a claim for TECVAYLI were included in the study.
• The mean (SD) Quan-Charlson Comorbidity Index (Quan-CCI) score was 4.0 (3.6) for the overall population, and the cohort indexed in March 2023 had the highest Quan-CCI score of 5.6 (3.8).
• Of the 92 patients who met the criteria for evaluable treatment history, 15 (16.3%) had prior exposure to a commercial B-cell maturation antigen (BCMA) therapy.

HCRU During SUD

• Of the 131 patients who had a complete SUD period by the data cutoff, 112 (85.5%) completed TECVAYLI SUD in 1 IP admission.
  • Of the 19 (14.5%) patients with >1 encounter with SUD, 2 (10.5%) were all IP admissions, 5 (26.3%) were all OP administrations, and 12 (63.2%) were in IP IP/OP settings.
• The median (interquartile range) LOS was 8.0 (4.0) days (mean [SD], 8.5 [3.0] days) after omitting extreme outliers (N=115) among 126 (96.2%) patients with ≥1 TECVAYLI-related hospitalization during SUD.
• Over time, the mean (SD) LOS in patients who had ≥1 TECVAYLI-related hospitalization during SUD decreased from 11.4 (9.0) days for patients indexed through February 2023 to 7.0 (1.4) days for those indexed in July 2023 (outliers included). See Table: Mean LOS Among Patients With ≥1 TECVAYLI-Related Admission During SUD (n=126).

Safety - CRS Events

• Of the 131 patients with a complete SUD period, 54 (41.2%) had an ICD-10-CM diagnosis code for CRS and 32 (24.4%) experienced CRS-related symptoms per the Keating algorithm. See Table: Real-World CRS Events Among Patients Who Completed TECVAYLI SUD.

• During the complete SUD period, 7 (5.3%) patients had tocilizumab-related claims, 14 (10.7%) had dexamethasone-related claims, 8 (6.1%) had antihistamine-related claims, and 4 (3.1%) had acetaminophen-related claims.

SUD Patterns and LOS in Acentrus MM EMRs

Banerjee et al (2023)¹ presented a real-world, retrospective analysis of Acentrus MM EMRs that evaluated the dosing patterns, HCRU, and the early safety outcomes during TECVAYLI SUD among US patients receiving TECVAYLI.

Study Design/Methods

• Adult patients (≥18 years old) with MM who had received ≥1 dose of TECVAYLI between October 26, 2022, and May 31, 2023, were included.
• Patients with diagnosis codes for clinical trials on the index date or those who had indicators of receiving TECVAYLI in a clinical trial setting were excluded.
• Patients were indexed on the day of the first TECVAYLI dose.
• Patient characteristics were captured during the 6-month baseline period before the index date.
• Dosing patterns, healthcare settings (IP or OP), LOS at the hospital, and rate, severity, and treatment for CRS and ICANS were described among patients with complete SUD data.
• Patients were considered to have complete SUD data if they had received the 2 SUDs (30 mg/3 mL vial size) and the first treatment dose (153 mg/1.7 mL vial size), with strength confirmed in the database, and had at least 7 days of data or the next dose observed after the first treatment dose (to allow sufficient time for capturing treatment outcomes of the first dose) by the data cutoff.

Results

• A total of 104 patients (median age, 65 years [range, 43-89]; male, 58%) were included in the study.
• Prevalent baseline comorbidities included anemia (67%), hypertension (57%), renal impairment/failure (54%), lytic bone lesions (35%), hypogammaglobulinemia (25%), and extramedullary plasmacytomas (12%).
• Twenty-five percent of patients were previously treated with BCMA-targeted therapies.

SUD Patterns

• In the cohort of 104 patients, data pertaining to SUD were available for 76 patients. Within this subset, 65 patients (86%) completed the SUD in an all-IP setting. Additionally, 64/65 (98%) patients received all 3 doses in a single admission. Alternatively, 10 patients (13%) received all 3 doses in an OP setting. One patient received SUD in IP as well as OP settings.
• A total of 42% of patients had an exact 2-day dosing interval (eg, days 1-3-5), and 16% of patients had an exact 3-day dosing interval (eg, days 1-4-7); 75% of patients received the third dose within 7 days of TECVAYLI initiation.
• Among the 36 patients with detailed IP data, the median LOS for IP SUD was 8.0 days, excluding 1 extreme outlier. Median LOS generally trended downward over time, from 11 days in December 2022 to 6.5 days in May 2023. See Table: Hospital LOS for TECVAYLI SUD by Index Month.

Safety

• Data pertaining to CRS and ICANS in patients with complete SUD (n=76) have been summarized in Table: CRS and ICANS Outcomes in Patients With Complete SUD.
• A total of 99% of patients received acetaminophen, 96% received diphenhydramine, and 71% received corticosteroids on the days of TECVAYLI administration.
  • No patients received prophylactic treatments within 2 days prior to the administration of the first TECVAYLI dose.
• A total of 3% of patients received tocilizumab on the same day as their first dose (unclear whether tocilizumab was given for prophylaxis or treatment), and 12% received tocilizumab after TECVAYLI dosing.

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 21 August 2026.