Matching-Adjusted Indirect Treatment Comparison (MAIC) of Teclistamab Versus Selinexor-Dexamethasone for the Treatment of Patients with Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM)
Author(s)
Moreau P1, Usmani SZ2, van de Donk NWCJ3, Garfall AL4, Delforge M5, Oriol A6, Nooka A7, Rosiñol L8, Bahlis N9, Rodríguez Otero P10, Martin TG11, Diels J12, Van Sanden S12, Pei L13, Ammann E14, Chastain K13, Marshall A14, Slavcev M14, Londhe A15, Krishnan A16
1Hematology Clinic, University Hospital Hôtel-Dieu, Nantes, France, 2Memorial Sloan Kettering Cancer Center, New York, NY, USA, 3Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, North Holland, Netherlands, 4Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA, 5Department of Haematology, University of Leuven, Leuven, Belgium, 6Institut Català d’Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain, 7Winship Cancer Institute, Emory University, Atlanta, GA, USA, 8Hospital Clinic, IDIBAPS, University of Barcelona, Barcelona, Spain, 9Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, AB, Canada, 10Clínica Universidad de Navarra, CIMA, CIBERONC, IDISNA, Pamplona, Navarra, Spain, 11University of California San Francisco, San Francisco, CA, USA, 12Janssen Pharmaceutica NV, Beerse, Belgium, 13Janssen Research & Development, Raritan, NJ, USA, 14Janssen Global Services, Raritan, NJ, USA, 15Janssen Research & Development, Titusville, NJ, USA, 16City of Hope Comprehensive Cancer Center, Irvine, CA, USA
Presentation Documents
OBJECTIVES: Teclistamab is the only approved BCMA×CD3 bispecific antibody with a personalized, weight-based dosing schedule for the treatment of TCE RRMM. We assessed the comparative efficacy of teclistamab vs selinexor-dexamethasone for patients with TCE RRMM.
METHODS: An unanchored MAIC used individual patient-level data (IPD) for patients who received teclistamab (1.5 mg/kg subcutaneous QW, Q2W, or Q4W; clinical cut-off: Jan 4, 2023; N=165) in MajesTEC-1 (NCT03145181/NCT04557098) and published summary-level data from treated patients in STORM Part 2 (NCT02336815, N=122). IPD from MajesTEC-1 patients meeting STORM Part 2 eligibility criteria were included, weighted to match aggregated STORM Part 2 baseline characteristics (BCs). The analysis adjusted for BCs of prognostic significance (refractory status, cytogenetics, R-ISS stage, extramedullary disease, number of prior lines of therapy). Comparative efficacy was estimated for ORR, ≥VGPR rate, ≥CR rate, DOR, PFS, and OS. Relative effects were quantified using an odds ratio (OR), 95% CI, and risk ratio (RR) derived from a weighted logistic regression analysis (binary endpoints). Hazard ratios (HRs), including 95% CI, were estimated using a weighted Cox proportional hazards model (time-to-event endpoints).
RESULTS: BCs for reweighted MajesTEC-1 patients were balanced with the STORM Part 2 population. Patients treated with teclistamab had improved ORR (OR, 2.91; [95% CI, 1.42–5.98]; RR, 1.94; P=0.0036), ≥VGPR rate (OR, 13.84; [5.45–35.17]; RR, 7.51; P<0.0001), ≥CR rate (OR, 38.69; [8.33–179.62]; RR, 23.91; P<0.0001), DOR (HR, 0.06; [0.03–0.14; P<0.001), PFS (HR, 0.61; [0.33–1.13]; P=0.1164), and OS (HR, 0.55; [0.33–0.93]; P=0.0265) vs selinexor-dexamethasone. Cross-trial differences in BCs led to a relatively low effective sample size (n=43) after adjustment, resulting in wide CIs for some outcomes.
CONCLUSIONS: Using updated MajesTEC-1 data, these analyses demonstrated improved efficacy of teclistamab vs selinexor-dexamethasone, highlighting the clinical benefit of teclistamab in patients with TCE RRMM, a population with a high unmet medical need.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
CO93
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Comparative Effectiveness or Efficacy, Meta-Analysis & Indirect Comparisons
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology