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5154 Real-World Treatment Outcomes of Teclistamab Under an Outpatient Model for Step-up Dosing Administration

Program: Oral and Poster Abstracts
Session: 905. Outcomes Research—Lymphoid Malignancies: Poster III
Hematology Disease Topics & Pathways:
Research, Biological therapies, Clinical Practice (Health Services and Quality), Bispecific Antibody Therapy, Clinical Research, health outcomes research, Diseases, real-world evidence, Therapies, Adverse Events, Lymphoid Malignancies
Monday, December 11, 2023, 6:00 PM-8:00 PM

Tyler B. Sandahl, PharmD1*, Scott A. Soefje1*, Ediz S. Calay2*, Yi Lin, MD, PhD3, Rafael Fonseca, MD4, Sikander Ailawadhi5, Ricardo Parrondo, MD5, Dee Lin6*, Bingcao Wu6*, Eli Silvert2*, Nina Kim6*, Corinne Carpenter2*, Tyler E. Wagner2*, Jessica Fowler, PhD7*, Laura Hester8*, Alexander Marshall9*, Patrick Stoy10, Dina Gifkins11* and Shaji Kunnathu Kumar, MD12

1Mayo Clinic, Rochester, MN
2nference Inc., Cambridge, MA
3Mayo Clinic Cancer Center, Rochester, MN
4Mayo Clinic, Phoenix, AZ
5Mayo Clinic, Jacksonville, FL
6Janssen Scientific Affairs, LLC, Horsham, PA
7Johnson & Johnson, Horsham, PA
8Janssen R&D, LLC, Horsham, PA
9Janssen Global Services, LLC, Raritan, NJ
10Janssen US Medical Affairs, Horsham, PA
11Janssen R&D, LLC, Titusville, NJ
12Division of Hematology, Mayo Clinic, Rochester, MN

Background

Teclistamab, the first-in-class B-cell maturation antigen (BCMA) x CD3 bispecific therapy was recently approved by the FDA for the treatment of triple-class exposed relapsed or refractory multiple myeloma (MM) after ≥ 4 prior lines of therapy. Because of the risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), the step-up dosing (SUD) of teclistamab is commonly administered in an inpatient setting among early users. Mayo Clinic has a well-established hospital-based outpatient program for novel immunotherapies. Since the FDA approval, teclistamab SUD has been administered as part of this program. Each dose of the SUD is administered in an outpatient setting, and the patient is given a remote monitoring kit to regularly measure vital signs and stay connected with the command center for signs and symptoms of CRS and ICANS throughout the entire SUD period. This study aimed to evaluate early safety outcomes and healthcare resource utilization during SUD in real-world (RW) patients who initiated teclistamab under the outpatient administration model across 3 Mayo Clinic locations (Rochester, MN, Phoenix/Scottsdale, AZ, Jacksonville, FL).

Methods

This was a retrospective study using Mayo Clinic’s electronic medical records from October 26, 2022 to June 12, 2023. Eligible patients were adults diagnosed with MM who had initiated commercial teclistamab at any of the 3 Mayo Clinic locations. Patient characteristics, rates and severity of CRS and ICANS, as well as healthcare resource utilization during SUD were described. Time between teclistamab administration and patient check-out was reported for SUD and treatment doses, respectively.

Results

At the time of data cutoff, 39 patients received at least 1 teclistamab dose across the 3 locations (median age 67.2 years; male: 74%; White: 87%; non-Hispanic: 92%), including 36 patients who initiated teclistamab SUD directly in an outpatient setting. A total of 8 (21%) patients had MM with high-risk cytogenetics and 14 (36%) had prior exposure to other BCMA-targeted therapies. Prevalent comorbidities prior to receiving teclistamab included anemia (77%), hypertension (56%), lytic bone lesions (51%), neutropenia (49%), and hypogammaglobulinemia (41%). Renal impairment or failure was observed in 31% of the patients (Table 1).

Almost all patients received acetaminophen (95%), diphenhydramine (95%), and dexamethasone (92%) as pre-medications on the same day as teclistamab administrations during SUD. Of the teclistamab doses with clinic time data, the majority (62%) of doses during SUD required 30 minutes to 1 hour of clinic time for monitoring between administration and check-out. After SUD, the clinic time for weekly treatment doses decreased to less than 30 minutes for most (79%) doses (Figure 1). In patients who completed SUD by data cutoff (n = 37), most patients (70%) received the SUD on a 3-day dose interval (i.e., day 1, 4, 7). The mean time between the first and third doses was 6.3 days.

Among the 37 patients with complete SUD, 12 (32%) developed CRS. The highest CRS grade was grade 1 for 10 patients; 1 patient had a grade 2 CRS, and 1 patient had a grade 4 CRS. The patient with grade 4 CRS concurrently decompensated during a dialysis session and all symptoms were considered for CRS grading. A total of 6 patients had recurrent CRS, including 1 patient with 3 events during SUD. All patients who developed CRS during SUD (n=12) were admitted to the hospital for treatment, with a total of 19 admissions across all patients and a median length of stay of 1.7 days per admission. Among patients who were admitted for CRS (n=12), the majority were treated with acetaminophen (92%), diphenhydramine (83%) and dexamethasone (83%); tocilizumab was given to the 2 patients with CRS grade 2 or higher. Only 1 ICANS event (grade 2) was observed in 1 patient during SUD, after dose 3, and the patient was admitted to the hospital for treatment.

Conclusion

This study evaluated early RW safety outcomes of teclistamab under an outpatient administration model and found the CRS rate and severity to be comparable with other RW evidence generated from various data sources. Outcomes related to teclistamab SUD from Mayo Clinic supported the safety and feasibility of outpatient administration model as a potential option to reduce healthcare resource utilization and improve treatment experiences.

Disclosures: Sandahl: Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees. Calay: GeneDx: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Fonseca: Janssen: Consultancy; Takeda: Consultancy; Adaptive Biotechnologies: Membership on an entity's Board of Directors or advisory committees; Caris Life Sciences: Membership on an entity's Board of Directors or advisory committees; AbbVie: Consultancy; Adaptive Biotechnologies: Consultancy; Binding Site: Consultancy; Aztrazenica: Consultancy; FISH: Patents & Royalties: FISH; Millenium: Consultancy; AZBio: Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy; AMGEN: Consultancy; BMS (Celgene): Consultancy; Bayer: Consultancy; Antegene: Membership on an entity's Board of Directors or advisory committees; Regeneron: Consultancy; Oncotracker: Membership on an entity's Board of Directors or advisory committees; Pharmacyclics: Consultancy; Pfizer: Consultancy; Merck: Consultancy; Kite: Consultancy; Juno: Consultancy. Ailawadhi: AbbVie, Amgen, Ascentage, BMS, Cellectar, GSK, Janssen, Pharmacyclics, Sanofi: Research Funding; Beigene, BMS, Cellectar, GSK, Janssen, Pfizer, Regeneron, Sanofi, Takeda: Consultancy. Lin: Janssen Scientific Affairs, LLC.: Current Employment, Current equity holder in publicly-traded company. Wu: Janssen Scientific Affairs, LLC: Current Employment, Current equity holder in publicly-traded company. Silvert: nference: Consultancy, Current Employment, Current holder of stock options in a privately-held company. Kim: Janssen: Current Employment. Carpenter: nference Inc.: Ended employment in the past 24 months. Wagner: Anumana, Inc.: Current Employment, Current equity holder in private company, Current holder of stock options in a privately-held company, Patents & Royalties. Fowler: Janssen: Current Employment. Hester: Janssen R&D, LLC: Current Employment, Current equity holder in publicly-traded company. Marshall: Johnson & Johnson: Current Employment, Current equity holder in publicly-traded company. Stoy: Janssen Biotech, Inc: Current Employment, Current equity holder in publicly-traded company; GlaxoSmithKline: Current equity holder in publicly-traded company. Gifkins: Janssen R&D, LLC: Current Employment, Current equity holder in publicly-traded company.

*signifies non-member of ASH