Type: Oral
Session: 907. Outcomes Research: Plasma Cell Disorders: Bispecific Antibodies and CAR-T Therapies in Myeloma-The Yin and Yang of Powerful Therapies
Hematology Disease Topics & Pathways:
Research, Adult, Clinical Research, Health outcomes research, Plasma Cell Disorders, Diseases, Real-world evidence, Treatment Considerations, Biological therapies, Lymphoid Malignancies, Adverse Events, Monoclonal Antibody Therapy, Study Population, Human
Teclistamab, a first-in-class B-cell maturation antigen (BCMA) x CD3 bispecific antibody, gained US regulatory approval for relapsed/refractory multiple myeloma (MM) on 10/2022. Early initiators of teclistamab were commonly treated in academic systems. As healthcare institutions gain experience with teclistamab, administration models are evolving towards outpatient and/or community-based step-up dosing (SUD) administration. Current real-world studies on teclistamab have predominantly focused on patients (pts) treated in academic health systems, with limited evidence characterizing experiences with teclistamab in community settings. This study aimed to address this evidence gap by describing real-world patient profiles and outcomes in pts with MM receiving teclistamab in academic and community settings.
Methods
This retrospective observational analysis used Flatiron Health’s oncology electronic health record database and medical charts. Pts with MM (≥18 years) who received teclistamab from 10/25/22 to 12/31/23 were included. Pts were indexed on the first recorded teclistamab dose and stratified by setting (academic or community). Pt demographics and clinical characteristics were captured 6 months prior to or on the index date. MM treatment history was captured any time before the index date. Demographic and clinical characteristics, treatment patterns, infection rates, and overall response rate (ORR) were summarized descriptively. Clinical response criteria were predefined using published guidelines based on prior studies of the Flatiron Health database (i.e., ORR was captured using Flatiron’s biochemical definition of partial response or very good partial response).
Results
Among 156 pts who met study criteria, 111 (71%) and 45 (29%) were included in the academic and community cohorts, and among those, 95 (86%) and 39 (87%) completed teclistamab SUD as of data cutoff, respectively. Of the 39 pts in the community cohort, all pts were observed to have remained in the community setting for SUD. Pts in the academic cohort had a median age of 68 years (range: 37-85), and 27% were ≥75 years; pts in the community cohort had a median age of 73 years (range: 43-85), and 47% were ≥75 years. Black pts accounted for 19% and 14% in the academic and community cohorts, respectively. At teclistamab initiation, 64% pts in the academic cohort and 56% in the community cohort had an ECOG score of 0-1. High-risk cytogenetics were reported in 36% and 31% of pts in the academic and community cohorts, respectively. Relevant comorbidities included anemia (82% and 53%), renal impairment (34% and 18%), peripheral neuropathy (32% and 9%), and extramedullary disease (39% and 27%) for pts in the academic and community cohorts, respectively. Prior to receiving teclistamab, median lines of therapy were 6 (range: 1-15) in the academic cohort and 5 (range: 1-18) in the community cohort; prior exposure to BCMA-targeted therapies was observed in 34% and 22% of pts in the academic and community cohorts, respectively.
With a median follow-up of 3.7 months (range: 0.1-12.5) in the academic cohort and 2.8 months (range: 0.1-12.3) in the community cohort, infections were reported in 44 (40%) and 16 (36%) of pts, respectively. Infections led to a hospital admission in 11 (10%) of pts treated in academic setting and 3 (7%) pts in community setting. The ORR was observed to be 62% in academic and 81% in community practices.
Conclusion
This real-world study observed that most teclistamab-treated pts with MM in the Flatiron database were treated primarily in academic systems; however, over a quarter were treated in community settings. Notably, more community-based pts were older yet had lower disease burden and were less heavily pretreated than academic-based pts. Nonetheless, community-treated pts were observed to have significant disease burden. Despite this, most community-based pts remained within the community setting to complete SUD. Coupled with the high ORR observed, this analysis highlights the feasibility of administering teclistamab in the community setting. Infections that led to hospitalization were observed to be low, though longer follow-up time is needed to confirm these findings. This study highlights the potential opportunity to improve outcomes in MM through expanded access of teclistamab in community-based care settings.
Disclosures: Afrough: Sanofi: Honoraria, Other: Data safety monitoring/advisory board; Bristol-Myers Squibb: Honoraria, Other: Data safety monitoring/advisory board; Karyopharm: Honoraria, Other: Data Safety Monitoring/Advisory Board; Janssen: Research Funding; K36 Therapeutics: Research Funding; AbbVie: Research Funding; Adaptive Biotechnology: Research Funding. Khan: UT Southwestern Medical Center: Current Employment; Sanofi: Honoraria, Research Funding. Chinaeke: Johnson & Johnson Innovative Medicine: Current Employment; Johnson & Johnson: Current equity holder in publicly-traded company. Kim: Johnson & Johnson: Current Employment, Current equity holder in publicly-traded company. He: Merck & Co. Inc.: Current equity holder in publicly-traded company; Johnson & Johnson: Current equity holder in publicly-traded company; Johnson & Johnson Innovative Medicine: Current Employment. Min: Johnson & Johnson Innovative Medicine: Current Employment, Current equity holder in publicly-traded company; Amgen: Current equity holder in publicly-traded company; Amneal: Current equity holder in publicly-traded company; Danaher: Current equity holder in publicly-traded company; Novartis: Current equity holder in publicly-traded company; Bristol-Myers Squibb: Current equity holder in publicly-traded company; Merck: Current equity holder in publicly-traded company; Novo Nordisk: Current equity holder in publicly-traded company; Eli Lilly: Current equity holder in publicly-traded company; Thermo Fisher Scientific: Current equity holder in publicly-traded company; Brainstorm Cell Therapeutics: Current equity holder in publicly-traded company; Regeneron: Current equity holder in publicly-traded company; Cardinal Health: Current equity holder in publicly-traded company; McKesson: Current equity holder in publicly-traded company; Lam Research: Current equity holder in publicly-traded company; Abbott: Current equity holder in publicly-traded company; Sandoz Group AG: Current equity holder in publicly-traded company. Wu: Johnson & Johnson: Current Employment, Current equity holder in publicly-traded company. Lin: Johnson & Johnson Innovative Medicine: Current Employment, Current equity holder in publicly-traded company, Current holder of stock options in a privately-held company. Paner-Straseviciute: Johnson and Johnson Innovative Medicine: Current Employment. Hester: Janssen Research & Development, LLC: Current Employment, Current equity holder in publicly-traded company; Johnson and Johnson: Current holder of stock options in a privately-held company; Johnson & Johnson Innovative Medicine: Current Employment. Fowler: Johnson & Johnson Innovative Medicine: Current Employment; Johnson & Johnson: Current equity holder in publicly-traded company; Amgen: Current equity holder in private company. Walker: Sierra Medical Affairs LLC, Contracted to Janssen: Current Employment; Johnson and Johnson: Current equity holder in publicly-traded company. Hearty: Johnson & Johnson: Current Employment, Current equity holder in publicly-traded company. Anderson: AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; GSK: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Beigene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Prothena: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: DSMB; Cellectar Biosciences: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Karyopharm: Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Honoraria, Other: Travel Expenses, Research Funding.