Использование " Teclistamab " в реальных мировых ресурсах для обеспечения безопасности и охраны здоровья в рамках Амбулаторной модели управления по уходу за пациентами.

INTRODUCTION

The emergence of T-cell redirection therapy, including B-cell maturation antigen (BCMA)–targeted chimeric antigen receptor (CAR) T-cell therapies and bispecific antibodies, has resulted in high response rates in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM), with overall response rates reported in clinical trials ranging from 63% to 97%. 1 - 3 Teclistamab, the first BCMA × CD3 bispecific antibody, gained US regulatory approval in October 2022 for adult patients with triple-class exposed (defined as having received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody) RRMM on the basis of the phase 1/2 MajesTEC-1 clinical trial. 1 T-cell redirection therapies, including teclistamab, have been associated with cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS). To reduce the risk of these adverse events (AEs), teclistamab is initiated using a step-up dosing (SUD) schedule, which includes two step-up doses (0.06 mg/kg and 0.3 mg/kg) and the first full treatment dose (1.5 mg/kg) 2-4 days apart. 4

CONTEXT

Key Objective

Can teclistamab step-up dosing (SUD) be administered safely in an outpatient setting in patients with multiple myeloma (MM)?

Knowledge Generated

Sixty-five patients with MM were treated with teclistamab at Mayo Clinic, across three different locations, between October 26, 2022, and October 31, 2023; 58 (89%) patients initiated teclistamab SUD in an outpatient setting, including 57 who completed SUD by data cutoff. Of the 57 patients, 18 (31.6%) developed cytokine release syndrome (CRS) and two had immune effector cell–associated neurotoxicity syndrome (ICANS). All CRS and ICANS resolved, and all patients continued with teclistamab.

Relevance

As teclistamab is increasingly used in real world, the SUD model for teclistamab continues to evolve, shifting from inpatient to outpatient settings to reduce health care resource utilization and improve treatment experience while ensuring patient safety. Findings of this study add evidence to support institutions and providers that seek to initiate teclistamab SUD in an outpatient setting.

Early users of teclistamab commonly received SUD in a hospital setting for close patient monitoring. As teclistamab use in the clinical practice increases, health care institutions are exploring outpatient SUD administration as an option to reduce health care resource utilization (HRU) and improve patient experiences while ensuring patient safety. 5 , 6 Since teclistamab approval in the United States, Mayo Clinic has pioneered an outpatient model for administering teclistamab SUD as part of its well-established, hospital-based outpatient (HBO) program for immunotherapies. 7 Under this program, eligible patients receive teclistamab SUD in an HBO clinic and are monitored remotely throughout the SUD period for signs and symptoms of CRS and ICANS. To receive outpatient SUD, patients are required to stay within 30 minutes of the clinic and have access to 24-hour caregiver support. Patients may receive inpatient SUD if they lack a caregiver or if they are deemed too frail for outpatient monitoring by their physicians. Following each SUD dose, patients are monitored for immediate hypersensitivity reactions for 30 minutes in the clinic. The HBO remote patient monitoring model involves a technology package for patient to use at home that comprises a tablet and Bluetooth-enabled devices (blood pressure cuff and monitor, pulse oximeter, and thermometer). The tablet notifies patients to measure vital signs and complete condition-specific symptom assessments every 4 hours while awake and more frequently if experiencing symptoms. Nurses on the HBO team respond to alerts triggered by predetermined parameters, leveraging standardized decision trees and protocols for interventions and escalation as appropriate. The registered nurses in the Mayo Clinic Command Center are the initial responders to any alerts that require further assessment. Patients are seen daily in the HBO clinic and educated to contact the HBO clinic team for symptoms or abnormal vital signs during SUD. Depending on Mayo Clinic site and the onset timing of symptoms, patients may be admitted directly to the cellular therapy service through the HBO clinic or through the emergency department (ED) for toxicity management.

In this study, we evaluated safety outcomes and HRU during the teclistamab SUD period among patients with RRMM who initiated teclistamab at Mayo Clinic. Findings of this study will inform the feasibility of administering teclistamab SUD in the outpatient setting and guide best practices to optimize HRU, cost, and patient outcomes.

METHODS

Study Design and Data Source

This retrospective observational study used data from Mayo Clinic's electronic medical record (EMR) system and was approved by the Mayo Clinic Institutional Review Board (23-000267). All data were collected during routine clinical care at Mayo Clinic. Mayo's clinical systems use a primary identifier and secondary identifiers to ensure that data are accurately and appropriately linked between various types of clinical data across different Mayo data sources. The primary identifier is a unique patient Medical Record Number that is used in all Mayo systems. Secondary identifiers, including a unique patient ID, are also used in the Mayo data warehouse. Data used in this study were extracted from the Mayo data warehouse and analyzed using standard python packages.

Study Population

Patients included in this study were adults (age ≥18 years) with multiple myeloma (MM) who initiated teclistamab at any of the three Mayo Clinic locations (Rochester, MN; Phoenix/Scottsdale, AZ; Jacksonville, FL) between October 26, 2022, and October 31, 2023 (data cutoff). These patients were identified using a combination of structured data and unstructured patient information. Patients who received teclistamab in a clinical trial were excluded.

Data Analysis

Patients were indexed on the first step-up dose and followed throughout the SUD period and until the data cutoff date. Baseline patient characteristics were captured during the 6-month period before or on the index date. Myeloma-specific characteristics such as risk of cytogenetics and previous use of BCMA-targeted therapies were captured at any time before the index date.

Characteristics were analyzed for all patients who received ≥1 teclistamab dose to understand the overall patient population treated with teclistamab, and then separately for those who initiated SUD in an outpatient setting. Dosing patterns during and post-SUD were evaluated in all patients who completed SUD at data cutoff regardless of the SUD setting. Safety outcomes (ie, rates and severity of CRS and ICANS), HRU (ie, hospital admission rate, length of hospital stay [LOS], ED visits, and intensive care unit [ICU] use), and AE management during SUD were assessed in patients who completed SUD in an outpatient setting (the outpatient subgroup). LOS per admission and total hospital days per patient during SUD were calculated using all inpatient stays, regardless of the cause. CRS-related hospital days were calculated between the time of patient admission for CRS and discharge or till the next teclistamab dose if the patient stayed in the hospital for a subsequent teclistamab dose after CRS was resolved. All calculated days were rounded up to the next whole day. All CRS and ICANS grades were determined by Mayo clinicians using the American Society for Transplantation and Cellular Therapy grading system 8 and coded in the EMR system. Furthermore, CRS was separately reported in patients with and without previous exposure to other BCMA-targeted therapies to evaluate the potential impact of previous BCMA exposure on CRS risk. ICANS rate was not stratified by previous BCMA exposure because of its low incidence. Clinic time between teclistamab administration and patient checkout was reported for each of the three SUD doses and post-SUD treatment doses (ie, dose 4 and beyond).

All variables were analyzed descriptively. Mean, standard deviation (SD), median, IQR, and/or range were reported for continuous variables; numbers and percentages were reported for categorical variables.

RESULTS

Patient Demographics and Characteristics

At data cutoff, 65 patients across the three Mayo Clinic locations received ≥1 teclistamab dose (Fig 1 ). Among this overall population, 58 (89.2%) initiated teclistamab SUD directly in an outpatient setting. In the outpatient population (median [range] age, 69.2 [38.7-85.6] years), most were male (63.8%), White (89.7%), and non-Hispanic (96.6%); 36 (62.1%) had MM with known high-risk cytogenetics, defined as having ≥1 of the following abnormalities: del(17p), t(4;14), t(14;16), t(14;20), and gain or amp(1q) (Table 1 ). Fourteen patients (24.1%) had previous exposure to BCMA-targeted therapies, including nine previously treated with CAR T-cell therapy (all ide-cel), four with belantamab mafodotin, and one with other BCMA-targeted bispecific antibody (pavurutamab). Prevalent comorbidities and MM-related conditions of interest before teclistamab included anemia (72.4%), peripheral neuropathy (67.2%), hypogammaglobulinemia (32.8%), hypertension (31%), renal impairment/failure (31%), and neutropenia (24.1%) (Table 1 ).

SUD Pattern and Dosing Schedule

Among 59 patients with complete SUD at data cutoff regardless of the administration setting, 32 (54.2%) completed SUD on an exact 3-day dose interval (ie, days 1, 4, and 7), three (5.1%) on a 2-day interval (ie, days 1, 3, and 5), and 24 (40.7%) had other dosing intervals (eg, days 1, 4, and 6; days 1, 3, and 6; and other dosing schedules that differ from the exact 2- and 3-day intervals). The median (IQR) time between the first and third SUD doses was 6 (6-7) days. At data cutoff, 43 patients received ≥2 post-SUD treatment doses; of these patients, five (11.6%) switched from weekly to an every-other-week treatment dosing schedule at a median (IQR) time to switching of 3.1 (1.4-6.6) months.

Safety Outcomes in the Outpatient Subgroup

Among the 57 patients who completed SUD in an outpatient setting, all received acetaminophen and diphenhydramine, and most received dexamethasone (N = 56; one patient was intolerant to dexamethasone and received prednisone) as premedications on the same day as teclistamab SUD administrations (Table 2 ). Eighteen patients (31.6%) developed CRS, including 13 (22.8%) with grade 1, four (7%) with grade 2, and one (1.8%) with grade 4 CRS (Table 2 ). The patient with grade 4 CRS concurrently decompensated during a dialysis session, and all symptoms were considered for CRS grading. This patient was managed in ICU for 3 days. Eight patients (14%) had recurrent CRS, including three patients with three events during the SUD (Table 2 ). Two patients (3.5%) developed ICANS (one each with grade 2 and 4). The patient with grade 4 ICANS had concurrent grade 2 CRS and presented with altered mental status and status epilepticus 6 days after the first full treatment dose and was managed with methylprednisolone, tocilizumab, lorazepam, and levetiracetam. Of note, this patient experienced grade 2 CRS with the first SUD dose, leading to delays in therapy and repeat of the first SUD dose and had grade 1 CRS with the second SUD dose. Following steroid taper, the patient resumed teclistamab with addition of dexamethasone premedication with no further incidence of CRS or ICANS.

Safety Outcomes in the Subgroups With and Without Previous BCMA-Targeted Therapies

Of the 16 patients with previous exposure to other BCMA-targeted therapies who completed SUD regardless of settings, 31.3% developed CRS, which is comparable with the CRS rate (32.6%) in patients without previous exposure to BCMA-targeted therapies.

HRU During SUD

Per Mayo Clinic's treatment protocol at the time of data analysis, patients who received outpatient SUD and developed any grade CRS were admitted to the hospital for treatment. In the outpatient subgroup (n = 57), a total of 27 admissions were observed across 18 patients who developed CRS (Table 2 ). The median (IQR) CRS-related hospital days were 2 (2-4) days per inpatient admission and 3 (2-6) total hospital days per patient. Considering admission for any reason, 26 patients (45.6%) had ≥1 inpatient admission, with a median (IQR) LOS of 3 (2-6) days per admission and 6 (4-9) total hospital days per patient. At the population level (among all 57 patients who completed SUD in an outpatient setting), 31 patients (54.4%) did not have any hospitalization, resulting in a median (minimum, Q1, Q3, maximum) LOS of 0 (0, 0, 5, 32) days per patient.

All patients with CRS were treated with acetaminophen, 17 (94.4%) with dexamethasone, and six (33.3%; three with grade 1 and three with grade 2 or higher CRS) with tocilizumab (Table 2 ). Of the two patients (3.5%) who were admitted to ICU because of CRS, the mean (SD) length of ICU stay was 2 (1.4) days. Nine patients (15.8%) visited ED for CRS and were admitted from ED. The two patients who developed ICANS were admitted to the hospital and treated with dexamethasone, methylprednisolone, and levetiracetam. All patients continued treatment with teclistamab after symptoms resolved.

Clinic Time

Among teclistamab doses with clinic time information (99%), most (60%) of the SUD doses required <1 hour of clinic time between teclistamab administration and patient checkout. After SUD, the clinic time for teclistamab treatment dose administration decreased to <30 minutes for most doses (82%; Fig 2 ).

DISCUSSION

To our knowledge, this is one of the first studies evaluating real-world patient safety outcomes of teclistamab SUD under an outpatient administration model. In this study, nearly 90% of all patients received teclistamab SUD in an outpatient setting. Consistent with the MajesTEC-1 trial and other real-world studies, 1 , 5 , 9 this study showed that teclistamab was well tolerated overall. Most CRS and ICANS were low grade and managed effectively with medication, and no patient discontinued teclistamab because of CRS or ICANS. Consistent with existing real-world evidence, 9 - 11 this study found that patients treated with teclistamab in a real-world setting were older and had high disease burden, and many had already tried another BCMA-targeted therapy before receiving teclistamab, compared with the participants in the MajesTEC-1 trial. 1 Despite advanced age and heavy disease burden, most patients completed the SUD per label-recommended dosing schedule.

All patients in this study who initiated teclistamab in an outpatient setting received premedications on the same day as teclistamab SUD administration per label recommendations to reduce the risk of AEs. Although six patients received tocilizumab as supportive care during SUD, none received tocilizumab prophylactically. Previous exposure to other BCMA-targeted therapeutics did not appear to affect CRS rates.

The CRS rate captured in this study (31.6%) was markedly lower than the MajesTEC-1 trial (72.1%) 1 and other real-world analyses, 10 , 12 whereas the ICANS rate (3.5%) was similar to MajesTEC-1 (3%). In a recent study by Dima et al, 12 CRS and ICANS were reported in 64% and 14% of patients who received teclistamab in an inpatient setting. In another study by Mohan et al, 10 the CRS and ICANS rates were reported in 56% and 11% of all patients who received teclistamab (91% of patients completed SUD in an inpatient setting). However, the CRS and ICANS rates captured in this study are similar to those reported in another study by Varshavsky Yanovsky et al 6 (33% and 5%, respectively) in which teclistamab SUD was administered in an outpatient setting and patients were monitored remotely.

Lower CRS and ICANS rates among patients receiving outpatient SUD compared with those reported in inpatient settings have been observed in other real-world analyses. In a real-world evaluation of teclistamab in patients with RRMM who were treated at six academic centers from three countries (the United States, Greece, and Spain), Maringanti et al 13 reported a higher CRS rate among patients treated in inpatient settings than those treated in outpatient settings (58% v 33%). This pattern of higher CRS rate in inpatient settings was also observed in another analysis by Asoori et al 5 on the basis of data from seven academic centers associated with the International Myeloma Foundation (57% inpatient CRS rate v 35% outpatient CRS rate). These differences likely reflect variations in how CRS events were captured and reported, as well as in CRS prophylaxis strategies between health institutions, but may also be due to selection bias, as high-risk patients may be admitted for full SUD at the provider's discretion. However, direct comparison of CRS rates between inpatient and outpatient settings is not feasible in this study because of the small sample size of patients receiving inpatient SUD. Additionally, patients receiving outpatient teclistamab SUD are monitored remotely. Many institutions use medical alert systems or rely on self-reporting of symptoms, so the CRS rates captured are expected to be lower than in inpatient settings where patients are observed more closely with stricter CRS reporting criteria. Furthermore, patients who receive outpatient SUD are more likely to receive prophylactic treatments, either onsite before checkout or to take home, to prevent potential hospital admission.

It is worth noting that most patients in this study with complete SUD did not have an observed CRS event and therefore were not admitted for CRS treatment. Among patients who were admitted for CRS, the median CRS-related hospital days were 2 days per admission and 3 days per patient. When considering the total hospital LOS for any reason, the median LOS was 3 days per admission and six per patient among those with ≥1 admission. At the population level, more than half of the patients did not have any admissions, compared with the median LOS of 9 days for inpatient teclistamab SUD administration reported in other real-world studies that included early patients treated with teclistamab. 10 , 12 Additional studies are needed to confirm these findings and to further evaluate the safety and feasibility and to quantify the economic impact of outpatient models for teclistamab SUD. A phase 2 study (ClinicalTrials.gov identifier: NCT05972135 ) designed to evaluate CRS incidence and severity after prophylactic tocilizumab in patients treated with teclistamab in the outpatient setting is currently recruiting. At the time of writing this manuscript, tocilizumab as prophylaxis had not been incorporated as a standard strategy in our practice. 14 Since the data cutoff, management strategies in our practice have evolved and patients with grade 1 CRS are now managed in the outpatient setting, likely further reducing admission rates and shortening LOS.

Safety of outpatient teclistamab SUD in patients with high disease burden or severe comorbidities, such as organ dysfunction, also merits additional evaluation. In this study, one patient on hemodialysis developed a grade 4 CRS event after receiving outpatient teclistamab. In a retrospective study of RRMM patients with end-stage renal failure requiring dialysis, Lachenal et al 15 reported that after receiving teclistamab within 1-2 days after dialysis, half of the patients developed CRS events (grade 1 or 2) that were resolved with tocilizumab and no patients developed ICANS. Although it appears to be safe to administer teclistamab to patients on hemodialysis, further evaluation is needed for patients who are frail and have severe comorbidities. 15

This study has a few limitations. First, it used electronic records from real-world clinical settings, which may be subject to miscoding and errors. Patient comorbidities were captured using International Classification of Diseases-10 codes, and some MM-specific conditions such as extramedullary disease may be under-reported. Second, it used EMR data from three Mayo Clinic sites, and information on patient care obtained outside of the Mayo Clinic may be incomplete. Thus, findings of this study may not be generalizable to the overall population of patients with MM. Additionally, other health care institutions may lack the infrastructure and resources available at the Mayo Clinic, and therefore, our outpatient model serves as an example but may not be universally applicable. Further research using multicenter data with a larger sample size is needed.

In conclusion, this study evaluated early real-world safety of teclistamab under an outpatient SUD administration model and found the outcomes comparable with other real-world evidence generated from various data sources. Outcomes related to teclistamab SUD from Mayo Clinic support the safety and feasibility of an outpatient SUD administration model as a potential option for teclistamab to reduce HRU and improve patient treatment experience.

Tyler B. Sandahl

Employment: Mayo Clinic, UnitedHealthcare (I)

Stock and Other Ownership Interests: CRISPR Therapeutics, Sio Gene Therapies, United Health Group

Consulting or Advisory Role: Janssen, Pfizer, BiolineRx

Research Funding: nference

Travel, Accommodations, Expenses: Janssen

Scott A. Soefje

Honoraria: Pharmacy Times Continuing Education

Consulting or Advisory Role: BeiGene, GlaxoSmithKline, Regeneron

Research Funding: Janssen Oncology, AstraZeneca

Rafael Fonseca

Employment: Mayo Clinic

Leadership: Antengene

Stock and Other Ownership Interests: Adaptive Biotechnologies, Caris Life Sciences, OncoMyx Therapeutics

Honoraria: Celgene, Bristol Myers Squibb, Bayer, Amgen, Janssen, Kite, a Gilead company, Merck Sharp & Dohme, Juno Therapeutics, Takeda, AbbVie, Aduro Biotech, Sanofi, OncoTracker

Consulting or Advisory Role: Celgene, Bristol Myers Squibb, Bayer, Amgen, Janssen, AbbVie, Kite, a Gilead company, Merck Sharp & Dohme, Juno Therapeutics, Takeda, Aduro Biotech, Sanofi, OncoTracker, GlaxoSmithKline, Karyopharm Therapeutics, Oncopeptides, Pfizer, Pharmacyclics, Regeneron, RA Capital

Patents, Royalties, Other Intellectual Property: Dr Fonseca has received a patent for the prognostication of MM based on genetic categorization of the disease

Travel, Accommodations, Expenses: Celgene, Bristol Myers Squibb, Bayer, Amgen, Janssen, Kite, a Gilead company, Merck Sharp & Dohme, Juno Therapeutics, Takeda, AbbVie, Aduro Biotech, Sanofi, OncoTracker

Other Relationship: Adaptive Biotechnologies, Caris Life Sciences

Sikander Ailawadhi

Consulting or Advisory Role: Takeda, BeiGene, GlaxoSmithKline, Sanofi, Pharmacyclics (Inst), BMS (Inst), Amgen (Inst), Janssen (Inst), Regeneron, Cellectar (Inst)

Research Funding: Pharmacyclics (Inst), Janssen Biotech (Inst), Cellectar (Inst), BMS (Inst), Amgen (Inst), GlaxoSmithKline (Inst), AbbVie (Inst), Ascentage Pharma (Inst), Sanofi (Inst)

Ricardo Parrondo

Consulting or Advisory Role: Sanofi Aventis GmbH, AstraZeneca

Research Funding: GlaxoSmithKline, Bristol Myers Squibb Foundation

Expert Testimony: MJH Life Sciences

Dee Lin

Employment: Johnson & Johnson/Janssen, Daiichi Sankyo (I)

Stock and Other Ownership Interests: Johnson & Johnson/Janssen

Bingcao Wu

Employment: Johnson & Johnson/Janssen

Stock and Other Ownership Interests: Johnson & Johnson/Janssen

Ediz S. Calay

Employment: nference

Nina Kim

Employment: Johnson & Johnson

Stock and Other Ownership Interests: Johnson & Johnson

Tyler E. Wagner

Employment: nference, Anumana, Inc

Stock and Other Ownership Interests: nference, Anumana, Inc

Patents, Royalties, Other Intellectual Property: Patents and patents pending for technologies developed by nference, Inc

Jessica Fowler

Employment: Janssen Oncology, Amgen

Stock and Other Ownership Interests: Amgen, Janssen Oncology

Laura Hester

Employment: Janssen Research & Development

Stock and Other Ownership Interests: Janssen, Oracle Health Sciences

Karthik Murugadoss

Employment: nference

Stock and Other Ownership Interests: nference

Research Funding: nference

Patents, Royalties, Other Intellectual Property: De-identification of EHR (nference)

Alexander Marshall

Employment: Johnson & Johnson/Janssen, Sanofi (I)

Stock and Other Ownership Interests: Johnson & Johnson/Janssen

Patrick Stoy

Employment: Johnson & Johnson/Janssen

Stock and Other Ownership Interests: Johnson & Johnson/Janssen, GlaxoSmithKline

Dina Gifkins

Employment: Johnson & Johnson/Janssen

Stock and Other Ownership Interests: Johnson & Johnson/Janssen

Yi Lin

Consulting or Advisory Role: Kite/Gilead (Inst), Bristol Myers Squibb (Inst), Vineti (Inst), Janssen Oncology (Inst), Pfizer (Inst), Sanofi (Inst), NexImmune (Inst), Caribou Biosciences (Inst), Regeneron (Inst), Genentech (Inst), Fosun Kite (Inst), Chimeric Therapeutics (Inst), Adicet Bio (Inst), Nektar (Inst)

Research Funding: Janssen Oncology (Inst), Bristol Myers Squibb (Inst)

Shaji Kumar

Consulting or Advisory Role: Takeda (Inst), Janssen Oncology (Inst), Genentech/Roche (Inst), AbbVie (Inst), Bristol Myers Squibb/Celgene (Inst), Pfizer (Inst), Regeneron (Inst), Sanofi (Inst), K36 (Inst)

Research Funding: Takeda (Inst), AbbVie (Inst), Novartis (Inst), Sanofi (Inst), Janssen Oncology (Inst), MedImmune (Inst), Roche/Genentech (Inst), CARsgen Therapeutics (Inst), Allogene Therapeutics (Inst), GlaxoSmithKline (Inst), Regeneron (Inst), Bristol Myers Squibb/Celgene (Inst)

Travel, Accommodations, Expenses: AbbVie, Pfizer

No other potential conflicts of interest were reported.

See accompanying Editorial, p. 596

PRIOR PRESENTATION

This work has been presented in part as a poster at the 2023 American Society of Hematology Annual Meeting, San Diego, CA on Dec 11, 2023. https://www.sciencedirect.com/science/article/pii/S0006497123117551 . Data included in this manuscript spans from October 26, 2022 to October 31, 2023, whereas the data in the poster spans from October 26, 2022 to June 12, 2023.

SUPPORT

Supported by Janssen Scientific Affairs, LLC, Horsham, PA. Editorial assistance was provided by Cobbs Creek Healthcare, LLC.

AUTHOR CONTRIBUTIONS

Conception and design: Tyler B. Sandahl, Scott A. Soefje, Rafael Fonseca, Sikander Ailawadhi, Ricardo Parrondo, Dee Lin, Bingcao Wu, Ediz S. Calay, Nina Kim, Corinne Carpenter, Tyler E. Wagner, Jessica Fowler, Alexander Marshall, Dina Gifkins, Yi Lin, Shaji Kumar

Administrative support: Scott A. Soefje

Provision of study materials or patients: Tyler B. Sandahl, Scott A. Soefje, Rafael Fonseca, Yi Lin

Collection and assembly of data: Tyler B. Sandahl, Ricardo Parrondo, Bingcao Wu, Ediz S. Calay, Eli Silvert, Tyler E. Wagner, Yi Lin, Shaji Kumar

Data analysis and interpretation: Tyler B. Sandahl, Scott A. Soefje, Rafael Fonseca, Sikander Ailawadhi, Ricardo Parrondo, Dee Lin, Bingcao Wu, Ediz S. Calay, Eli Silvert, Nina Kim, Tyler E. Wagner, Jessica Fowler, Laura Hester, Nivedita Rangarajan, Karthik Murugadoss, Alexander Marshall, Patrick Stoy, Dina Gifkins, Yi Lin, Shaji Kumar

Manuscript writing: All authors

Final approval of manuscript: All authors

Accountable for all aspects of the work: All authors

AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Real-World Safety and Health Care Resource Utilization of Teclistamab Under an Outpatient Model for Step-Up Dosing Administration

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/op/authors/author-center .

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians ( Open Payments ).

Tyler B. Sandahl

Employment: Mayo Clinic, UnitedHealthcare (I)

Stock and Other Ownership Interests: CRISPR Therapeutics, Sio Gene Therapies, United Health Group

Consulting or Advisory Role: Janssen, Pfizer, BiolineRx

Research Funding: nference

Travel, Accommodations, Expenses: Janssen

Scott A. Soefje

Honoraria: Pharmacy Times Continuing Education

Consulting or Advisory Role: BeiGene, GlaxoSmithKline, Regeneron

Research Funding: Janssen Oncology, AstraZeneca

Rafael Fonseca

Employment: Mayo Clinic

Leadership: Antengene

Stock and Other Ownership Interests: Adaptive Biotechnologies, Caris Life Sciences, OncoMyx Therapeutics

Honoraria: Celgene, Bristol Myers Squibb, Bayer, Amgen, Janssen, Kite, a Gilead company, Merck Sharp & Dohme, Juno Therapeutics, Takeda, AbbVie, Aduro Biotech, Sanofi, OncoTracker

Consulting or Advisory Role: Celgene, Bristol Myers Squibb, Bayer, Amgen, Janssen, AbbVie, Kite, a Gilead company, Merck Sharp & Dohme, Juno Therapeutics, Takeda, Aduro Biotech, Sanofi, OncoTracker, GlaxoSmithKline, Karyopharm Therapeutics, Oncopeptides, Pfizer, Pharmacyclics, Regeneron, RA Capital

Patents, Royalties, Other Intellectual Property: Dr Fonseca has received a patent for the prognostication of MM based on genetic categorization of the disease

Travel, Accommodations, Expenses: Celgene, Bristol Myers Squibb, Bayer, Amgen, Janssen, Kite, a Gilead company, Merck Sharp & Dohme, Juno Therapeutics, Takeda, AbbVie, Aduro Biotech, Sanofi, OncoTracker

Other Relationship: Adaptive Biotechnologies, Caris Life Sciences

Sikander Ailawadhi

Consulting or Advisory Role: Takeda, BeiGene, GlaxoSmithKline, Sanofi, Pharmacyclics (Inst), BMS (Inst), Amgen (Inst), Janssen (Inst), Regeneron, Cellectar (Inst)

Research Funding: Pharmacyclics (Inst), Janssen Biotech (Inst), Cellectar (Inst), BMS (Inst), Amgen (Inst), GlaxoSmithKline (Inst), AbbVie (Inst), Ascentage Pharma (Inst), Sanofi (Inst)

Ricardo Parrondo

Consulting or Advisory Role: Sanofi Aventis GmbH, AstraZeneca

Research Funding: GlaxoSmithKline, Bristol Myers Squibb Foundation

Expert Testimony: MJH Life Sciences

Dee Lin

Employment: Johnson & Johnson/Janssen, Daiichi Sankyo (I)

Stock and Other Ownership Interests: Johnson & Johnson/Janssen

Bingcao Wu

Employment: Johnson & Johnson/Janssen

Stock and Other Ownership Interests: Johnson & Johnson/Janssen

Ediz S. Calay

Employment: nference

Nina Kim

Employment: Johnson & Johnson

Stock and Other Ownership Interests: Johnson & Johnson

Tyler E. Wagner

Employment: nference, Anumana, Inc

Stock and Other Ownership Interests: nference, Anumana, Inc

Patents, Royalties, Other Intellectual Property: Patents and patents pending for technologies developed by nference, Inc

Jessica Fowler

Employment: Janssen Oncology, Amgen

Stock and Other Ownership Interests: Amgen, Janssen Oncology

Laura Hester

Employment: Janssen Research & Development

Stock and Other Ownership Interests: Janssen, Oracle Health Sciences

Karthik Murugadoss

Employment: nference

Stock and Other Ownership Interests: nference

Research Funding: nference

Patents, Royalties, Other Intellectual Property: De-identification of EHR (nference)

Alexander Marshall

Employment: Johnson & Johnson/Janssen, Sanofi (I)

Stock and Other Ownership Interests: Johnson & Johnson/Janssen

Patrick Stoy

Employment: Johnson & Johnson/Janssen

Stock and Other Ownership Interests: Johnson & Johnson/Janssen, GlaxoSmithKline

Dina Gifkins

Employment: Johnson & Johnson/Janssen

Stock and Other Ownership Interests: Johnson & Johnson/Janssen

Yi Lin

Consulting or Advisory Role: Kite/Gilead (Inst), Bristol Myers Squibb (Inst), Vineti (Inst), Janssen Oncology (Inst), Pfizer (Inst), Sanofi (Inst), NexImmune (Inst), Caribou Biosciences (Inst), Regeneron (Inst), Genentech (Inst), Fosun Kite (Inst), Chimeric Therapeutics (Inst), Adicet Bio (Inst), Nektar (Inst)

Research Funding: Janssen Oncology (Inst), Bristol Myers Squibb (Inst)

Shaji Kumar

Consulting or Advisory Role: Takeda (Inst), Janssen Oncology (Inst), Genentech/Roche (Inst), AbbVie (Inst), Bristol Myers Squibb/Celgene (Inst), Pfizer (Inst), Regeneron (Inst), Sanofi (Inst), K36 (Inst)

Research Funding: Takeda (Inst), AbbVie (Inst), Novartis (Inst), Sanofi (Inst), Janssen Oncology (Inst), MedImmune (Inst), Roche/Genentech (Inst), CARsgen Therapeutics (Inst), Allogene Therapeutics (Inst), GlaxoSmithKline (Inst), Regeneron (Inst), Bristol Myers Squibb/Celgene (Inst)

Travel, Accommodations, Expenses: AbbVie, Pfizer

No other potential conflicts of interest were reported.

REFERENCES

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2. Munshi NC, Anderson LD Jr, Shah N, et al. : Idecabtagene vicleucel in relapsed and refractory multiple myeloma. N Engl J Med 384:705-716, 2021

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4. Janssen : TECVAYLI [Prescribing Information]. 2024

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9. Gordon B, Fogel L, Varma G, et al. : Teclistamab demonstrates clinical activity in real-world patients ineligible for the pivotal MajesTEC-1 trial. Blood 142:4741, 2023

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13. Maringanti SA, Lin Y, Estritis S, et al. : MM-527 real world evaluation of teclistamab for the treatment of relapsed or refractory multiple myeloma (RRMM). Clin Lymphoma Myeloma Leuk 23:S506-S507, 2023

14. Rifkin RM, Sharman JP, Fowler J, et al. : Optec: A phase 2 study to evaluate outpatient administration of teclistamab, a BCMA-targeting bispecific antibody, in patients with multiple myeloma. Blood 142:3374, 2023

15. Lachenal F, Lebreton P, Bouillie S, et al. : Teclistamab in relapsed refractory multiple myeloma patients on dialysis: A French experience. Blood 142:4739, 2023