Real-World Patient Characteristics and Outcomes in Patients with Relapsed or Refractory Multiple Myeloma Receiving Teclistamab across Community Oncology Practices in the US

Background

Teclistamab (Tec) is a first-in-class B-cell maturation antigen (BCMA) x CD3 bispecific antibody approved in Oct 2022 for relapsed/refractory multiple myeloma (MM) and is initiated using a step-up dosing (SUD) approach. Early initiators commonly received Tec SUD in inpatient, academic settings; thus, limited literature on real-world patients (pts) treated with Tec in the community setting exists. To address this evidence gap, we evaluated real-world patient profiles, SUD patterns, and outcomes in pts with MM receiving Tec predominantly in US community settings.

Methods

This was a retrospective US multi-site chart review. Participating physicians from Cardinal Health's Oncology Provider Extended Network abstracted data from electronic medical charts of eligible pts. Eligible pts with MM (≥18 years) initiated Tec on or after 10/25/22 and had a minimum 1-month follow-up before the start of data abstraction (3/11/24); pts receiving Tec as part of a clinical trial were excluded. Pts were indexed on the first Tec dose. Characteristics and treatment history were captured during the pre-index baseline period; cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were captured during the SUD period; infections and clinical outcomes were captured during the follow-up period. All variables were analyzed descriptively in the overall population and in two subgroups of (1) pts considered MajesTEC-1 eligible by the physicians (TEC-1 eligible), and (2) pts who completed SUD fully in an outpatient setting (OP SUD).

Results

Nineteen physicians abstracted data for 101 pts (median age at index: 65 years [range: 51-92]; 65% male; 67% White; 26% Black; 92% non-Hispanic; 52% with commercial/Medicare Advantage; 34% with Medicare Fee-For-Service. Most providers (79%) were from community oncology practices, and most pts (94%) were directly managed by the abstracting physicians.

At Tec initiation, most pts (90%) had an ECOG score 0-1 and 38% had high-risk cytogenetics. Baseline comorbidities included anemia (33%) and renal impairment/failure (24%). Most pts (93%) did not have extramedullary disease at index. The median number of lines of therapy prior to Tec was 4 (range: 2-13); 9% of pts had prior exposure to other BCMA-targeted therapies. Per physician assessment, 74% of pts were identified as TEC-1 eligible.

During the SUD period, 34% of pts experienced CRS, all grades 1-2, and 11% had ICANS, majority of which (82%) were grades 1-2. Of 25 pts in the OP SUD subgroup, 2 (8%) experienced CRS (both grade 1) and 1 (4%) experienced ICANS (grade 3). None discontinued Tec due to CRS or ICANS.

At a median follow-up of 4.0 months (range: 0.9-15.1), 25% of pts developed infections while on Tec. Immunoglobulin (IVIG) as primary prophylaxis for infection was administered to 37% of pts overall; among them, 29 (78%) reported an IgG level <400 mg/dL prior to administration. Overall, 6% of pts were hospitalized and 2% discontinued Tec because of infections.

The overall response rate (ORR) was 76% among all pts and 83% among those in the TEC-1 eligible subgroup. The estimated progression-free survival (PFS) rate at 6 months post Tec initiation was 83% in the overall population and 91% among TEC-1 eligible subgroup.

Conclusion

In this US physician-led chart review, we found that most pts receiving Tec were treated at community practices and were considered to have been eligible for MajesTEC-1 trial by treating physicians. These pts were heavily pretreated and many had high risk cytogenetic abnormalities. While most pts were observed to have ECOG scores of 0-1 with no recent presence of extramedullary disease, other indicators of disease burden were present, such as high-risk cytogenetics, comorbidities, and many prior lines of therapy. Low rates and grades of CRS were seen in the overall and OP SUD population. No pts discontinued Tec due to CRS or ICANS. Additionally, consistently high ORR and 6-month PFS rate were observed in the overall and TEC-1 eligible subgroup of pts. This analysis will be updated with a larger sample size and longer follow-up to better evaluate infection rates and other clinical outcomes.

Dhakal:Carsgen: Research Funding; Sanofi: Research Funding; Acrellx: Research Funding; Bristol Myers Squibb: Honoraria, Research Funding; Janssen: Honoraria, Research Funding, Speakers Bureau; Pfizer: Consultancy, Honoraria, Speakers Bureau; Genentech: Consultancy, Honoraria; Karyopharm: Honoraria, Speakers Bureau; C4 therapeutics: Research Funding; Medical College of Wisconsin: Current Employment. Kim:Johnson & Johnson: Current Employment, Current equity holder in publicly-traded company. John:Cardinal Health: Current Employment; Bristol Myers Squibb: Research Funding; Daiichi Sankyo: Research Funding; Pfizer: Research Funding; Janssen: Research Funding; Sobi: Research Funding. Wu:Johnson & Johnson: Current Employment, Current equity holder in publicly-traded company. Lucht:Cardinal Health: Current Employment. Lin:Johnson & Johnson Innovative Medicine: Current Employment, Current equity holder in publicly-traded company, Current holder of stock options in a privately-held company. Bland:Cardinal Health: Current Employment. Paner-Straseviciute:Johnson and Johnson Innovative Medicine: Current Employment. Van Doren:Cardinal Health: Current Employment. Hester:Janssen Research & Development, LLC: Current Employment, Current equity holder in publicly-traded company; Johnson & Johnson Innovative Medicine: Current Employment; Johnson and Johnson: Current holder of stock options in a privately-held company. Giegerich:Children's Hospital of Philadelphia: Ended employment in the past 24 months; Cardinal Health: Current Employment. Fowler:Johnson & Johnson: Current equity holder in publicly-traded company; Johnson & Johnson Innovative Medicine: Current Employment; Amgen: Current equity holder in private company. Walker:Johnson and Johnson: Current equity holder in publicly-traded company; Sierra Medical Affairs LLC, Contracted to Janssen: Current Employment. Klink:Cardinal Health: Current Employment, Current equity holder in publicly-traded company, Current holder of stock options in a privately-held company. Hearty:Johnson & Johnson: Current Employment, Current equity holder in publicly-traded company. Feinberg:Cardinal Health: Current Employment, Current equity holder in publicly-traded company; Sickle Cell Foundation of Georgia Board: Membership on an entity's Board of Directors or advisory committees. Marshall:Johnson & Johnson: Current Employment. Doyle:Johnson and Johnson: Current Employment, Current equity holder in publicly-traded company. Voorhees:BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Consultancy; Regeneron: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Research Funding; Karyopharm: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Lava Therapeutics: Consultancy; GSK: Consultancy, Research Funding.