Comparative Effectiveness of Teclistamab Versus Real-World Physician’s Choice of Therapy (RWPC) for Patients with Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM)
Author(s)
Krishnan A1, Nooka A2, Chari A3, Garfall AL4, Martin TG5, Nair S6, Lin X7, Qi K8, Londhe A9, Pei L10, Ammann E11, Chastain K10, Parekh T12, Marshall A11, Slavcev M11, Usmani SZ13
1City of Hope Comprehensive Cancer Center, Irvine, CA, USA, 2Winship Cancer Institute, Emory University, Atlanta, GA, USA, 3Mount Sinai School of Medicine, New York City, NY, USA, 4Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA, 5University of California San Francisco, San Francisco, CA, USA, 6Janssen Pharmaceutica NV, Beerse, VAN, Belgium, 7Janssen Global Services, Horsham, PA, USA, 8Janssen Research and Development, Somerville, NJ, USA, 9Janssen Research & Development, Titusville, NJ, USA, 10Janssen Research & Development, Raritan, NJ, USA, 11Janssen Global Services, Raritan, NJ, USA, 12Janssen Research & Development, Bridgewater, NJ, USA, 13Memorial Sloan Kettering Cancer Center, New York, NY, 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. Approval was based on MajesTEC-1 (NCT03145181/NCT04557098), an open-label, single-arm, phase 1/2 trial in patients with RRMM who received ≥3 prior lines of therapy (LOT), including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. We assessed the comparative effectiveness of teclistamab vs physician’s choice of therapy using a real-world database.
METHODS: Individual patient data from MajesTEC-1 included patients (N=165) who received teclistamab (1.5 mg/kg subcutaneous QW, Q2W, or Q4W; clinical cut-off: Jan 4, 2023). An external control cohort for MajesTEC-1 was created from the Flatiron Health MM database, including patients who satisfied key MajesTEC-1 eligibility criteria (N=766 observations from 420 unique patients [Jan 2016–Aug 2021]; data cut-off: Dec 2022). Inverse probability of treatment weighting (IPTW) was used to adjust for imbalances in baseline covariates. Outcomes of interest included time to next treatment (TTNT), progression-free survival (PFS), and overall survival (OS). Outcomes were analyzed as time-to-event data using IPTW adjusted Kaplan-Meier estimates and a weighted Cox proportional hazards model. A sensitivity analysis, including additional covariates, was also performed.
RESULTS: After IPTW, baseline characteristics were comparable between cohorts. Patients treated with teclistamab had significantly improved TTNT (hazard ratio [HR], 0.36 [95% CI, 0.28–0.47]; P<0.0001) and PFS (HR, 0.44 [0.34–0.55]; P<0.0001), and numerically improved OS (HR, 0.81 [0.60–1.09]; P=0.16) vs RWPC. Outcomes for the sensitivity analysis were consistent with those from the primary analysis described above.
CONCLUSIONS: Using updated MajesTEC-1 data, teclistamab showed improved effectiveness for TTNT, PFS, and OS compared with RWPC in patients with TCE RRMM who received ≥3 prior LOT. These findings further support the clinical benefit of teclistamab 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)
Code
CO129
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Comparative Effectiveness or Efficacy, Meta-Analysis & Indirect Comparisons
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology