Adjusted Comparison of Teclistamab Versus Real-World Physician’s Choice (RWPC) of Therapy in Patients with Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM)
Author(s)
Mateos MV1, Chari A2, Usmani SZ3, Goldschmidt H4, Weisel K5, Qi K6, Londhe A6, Nair S7, Lin X8, Pei L9, Ammann E10, Chastain K9, Parekh T11, Marshall A10, Slavcev M10, Moreau P12
1University Hospital of Salamanca/IBSAL/CIC/CIBERONC, Zamora, ZA, Spain, 2Mount Sinai School of Medicine, New York City, NY, USA, 3Memorial Sloan Kettering Cancer Center, New York, NY, USA, 4Internal Medicine V, GMMG-Studygroup at University Hospital Heidelberg, Heidelberg, Germany, 5University Medical Center Hamburg-Eppendorf, Hamburg, Federal Republic of Germany, Germany, 6Janssen Research & Development, Titusville, NJ, USA, 7Janssen Pharmaceutica NV, Beerse, VAN, Belgium, 8Janssen Global Services, Horsham, PA, USA, 9Janssen Research & Development, Raritan, NJ, USA, 10Janssen Global Services, Raritan, NJ, USA, 11Janssen Research & Development, Bridgewater, NJ, USA, 12Hematology Clinic, University Hospital Hôtel-Dieu, Nantes, France
OBJECTIVES: Patients with RRMM who receive ≥3 prior lines of therapy (LOT) have limited treatment options. 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 effectiveness of teclistamab vs RWPC of therapy.
METHODS: Individual patient-level data for patients who received teclistamab (1.5 mg/kg subcutaneous QW, Q2W, or Q4W; clinical cut-off: Jan 4, 2023) in the phase 1/2 MajesTEC-1 trial (NCT03145181/NCT04557098) were compared with an external control arm. The control arm comprised patients treated with RWPC as subsequent therapy after discontinuing study treatment from 4 daratumumab trials (CASTOR, POLLUX, EQUULEUS, APOLLO) who met key eligibility criteria for MajesTEC-1 (N=427 unique patients; 806 observations). Inverse probability of treatment weighting (IPTW) was used to adjust for imbalances in baseline covariates. Outcomes of interest included ORR, ≥VGPR rate, TTNT, PFS, and OS. For binary endpoints, a weighted logistic regression method was used to derive an OR and 95% CI. A weighted Cox proportional hazards model was used to compute HRs and 95% CIs for time-to-event endpoints. A sensitivity analysis, including additional covariates, was also performed.
RESULTS: After IPTW adjustment, baseline characteristics were comparable between cohorts. Patients had significantly improved outcomes with teclistamab vs RWPC of therapy: ORR (OR, 4.80; 95% CI, 3.03–7.70; P<0.0001), ≥VGPR rate (OR, 12.37; 95% CI, 7.08–22.65; P<0.0001), TTNT (HR, 0.32; 95% CI, 0.24–0.41; P<0.0001), PFS (HR, 0.58; 95% CI, 0.45–0.75; P<0.0001), and OS (HR, 0.52; 95% CI, 0.39–0.68; P<0.0001). Results of the sensitivity analysis were statistically significant, in favor of teclistamab, and consistent with the primary analysis described above.
CONCLUSIONS: Using updated MajesTEC-1 data, these analyses demonstrated significantly improved effectiveness with teclistamab vs RWPC of therapy, highlighting its clinical benefit in patients with TCE RRMM who have limited treatment options.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Acceptance Code
P18
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Comparative Effectiveness or Efficacy, Meta-Analysis & Indirect Comparisons
Disease
no-additional-disease-conditions-specialized-treatment-areas, Oncology