TY - JOUR
T1 - Comparative Effectiveness of Teclistamab Versus Real-World Physician’s Choice of Therapy in LocoMMotion and MoMMent in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma
AU - Moreau, Philippe
AU - Mateos, María-Victoria
AU - Gonzalez Garcia, Maria Esther
AU - Einsele, Hermann
AU - de Stefano, Valerio
AU - Karlin, Lionel
AU - Lindsey-Hill, Joanne
AU - Besemer, Britta
AU - Vincent, Laure
AU - Kirkpatrick, Suriya
AU - Delforge, Michel
AU - Perrot, Aurore
AU - van de Donk, Niels W. C. J.
AU - Pawlyn, Charlotte
AU - Manier, Salomon
AU - Leleu, Xavier
AU - Martinez-Lopez, Joaquin
AU - Ghilotti, Francesca
AU - Diels, Joris
AU - Morano, Raúl
AU - Albrecht, Claire
AU - Strulev, Vadim
AU - Haddad, Imène
AU - Pei, Lixia
AU - Kobos, Rachel
AU - Smit, Jennifer
AU - Slavcev, Mary
AU - Marshall, Alexander
AU - Weisel, Katja
N1 - Funding Information: Medical writing support was provided by Kristin M. Allan, PhD, of Eloquent Scientific Solutions, and funded by Janssen Global Services, LLC. Funding Information: Open Access funding enabled and organized by Projekt DEAL. MajesTEC-1 and MoMMent were funded by Janssen Research & Development, LLC. LocoMMotion was funded by Janssen Research & Development, LLC, and Legend Biotech, Inc. Funding for the publication of this study, including the journal’s Rapid Service and Open Access fees, was provided by Janssen Global Services, LLC. Publisher Copyright: © 2023, The Author(s).
PY - 2023
Y1 - 2023
N2 - Introduction: Teclistamab is the first approved B cell maturation antigen × CD3 bispecific antibody with precision dosing for the treatment of triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM). We compared the effectiveness of teclistamab in MajesTEC-1 versus real-world physician’s choice of therapy (RWPC) in patients from the prospective, non-interventional LocoMMotion and MoMMent studies. Methods: Patients treated with teclistamab from MajesTEC-1 (N = 165) were compared with an external control arm from LocoMMotion (N = 248) or LocoMMotion + MoMMent pooled (N = 302). Inverse probability of treatment weighting adjusted for imbalances in prognostic baseline characteristics. The relative effect of teclistamab versus RWPC for overall response rate (ORR), very good partial response or better (≥ VGPR) rate, and complete response or better (≥ CR) rate was estimated with an odds ratio using weighted logistic regression transformed into a response-rate ratio (RR) and 95% confidence interval (CI). Weighted proportional hazards regression was used to estimate hazard ratios (HRs) and 95% CIs for duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Results: Baseline characteristics were well balanced between treatment cohorts after reweighting. Patients treated with teclistamab had significantly improved outcomes versus RWPC in LocoMMotion: ORR (RR [95% CI], 2.44 [1.79–3.33]; p < 0.0001), ≥ VGPR (RR 5.78 [3.74–8.93]; p < 0.0001), ≥ CR (RR 113.73 [15.68–825.13]; p < 0.0001), DOR (HR 0.39 [0.24–0.64]; p = 0.0002), PFS (HR 0.48 [0.35–0.64]; p < 0.0001), and OS (HR 0.64 [0.46–0.88]; p = 0.0055). Teclistamab versus RWPC in LocoMMotion + MoMMent also had significantly improved outcomes: ORR (RR 2.41 [1.80–3.23]; p < 0.0001), ≥ VGPR (RR 5.91 [3.93–8.88]; p < 0.0001), ≥ CR (RR 132.32 [19.06–918.47]; p < 0.0001), DOR (HR 0.43 [0.26–0.71]; p = 0.0011), PFS (HR 0.49 [0.37–0.66]; p < 0.0001), and OS (HR 0.69 [0.50–0.95]; p = 0.0247). Conclusion: Teclistamab demonstrated significantly improved effectiveness over RWPC in LocoMMotion ± MoMMent, emphasizing its clinical benefit as a highly effective treatment for patients with TCE RRMM. Trial Registration: MajesTEC-1, ClinicalTrials.gov NCT03145181 (phase 1) and NCT04557098 (phase 2); LocoMMotion, ClinicalTrials.gov NCT04035226; MoMMent, ClinicalTrials.gov NCT05160584.
AB - Introduction: Teclistamab is the first approved B cell maturation antigen × CD3 bispecific antibody with precision dosing for the treatment of triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM). We compared the effectiveness of teclistamab in MajesTEC-1 versus real-world physician’s choice of therapy (RWPC) in patients from the prospective, non-interventional LocoMMotion and MoMMent studies. Methods: Patients treated with teclistamab from MajesTEC-1 (N = 165) were compared with an external control arm from LocoMMotion (N = 248) or LocoMMotion + MoMMent pooled (N = 302). Inverse probability of treatment weighting adjusted for imbalances in prognostic baseline characteristics. The relative effect of teclistamab versus RWPC for overall response rate (ORR), very good partial response or better (≥ VGPR) rate, and complete response or better (≥ CR) rate was estimated with an odds ratio using weighted logistic regression transformed into a response-rate ratio (RR) and 95% confidence interval (CI). Weighted proportional hazards regression was used to estimate hazard ratios (HRs) and 95% CIs for duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Results: Baseline characteristics were well balanced between treatment cohorts after reweighting. Patients treated with teclistamab had significantly improved outcomes versus RWPC in LocoMMotion: ORR (RR [95% CI], 2.44 [1.79–3.33]; p < 0.0001), ≥ VGPR (RR 5.78 [3.74–8.93]; p < 0.0001), ≥ CR (RR 113.73 [15.68–825.13]; p < 0.0001), DOR (HR 0.39 [0.24–0.64]; p = 0.0002), PFS (HR 0.48 [0.35–0.64]; p < 0.0001), and OS (HR 0.64 [0.46–0.88]; p = 0.0055). Teclistamab versus RWPC in LocoMMotion + MoMMent also had significantly improved outcomes: ORR (RR 2.41 [1.80–3.23]; p < 0.0001), ≥ VGPR (RR 5.91 [3.93–8.88]; p < 0.0001), ≥ CR (RR 132.32 [19.06–918.47]; p < 0.0001), DOR (HR 0.43 [0.26–0.71]; p = 0.0011), PFS (HR 0.49 [0.37–0.66]; p < 0.0001), and OS (HR 0.69 [0.50–0.95]; p = 0.0247). Conclusion: Teclistamab demonstrated significantly improved effectiveness over RWPC in LocoMMotion ± MoMMent, emphasizing its clinical benefit as a highly effective treatment for patients with TCE RRMM. Trial Registration: MajesTEC-1, ClinicalTrials.gov NCT03145181 (phase 1) and NCT04557098 (phase 2); LocoMMotion, ClinicalTrials.gov NCT04035226; MoMMent, ClinicalTrials.gov NCT05160584.
KW - LocoMMotion
KW - MajesTEC-1
KW - MoMMent
KW - Relapsed or refractory multiple myeloma
KW - Teclistamab
KW - Triple-class exposed
UR - http://www.scopus.com/inward/record.url?scp=85180214906&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s12325-023-02738-0
DO - https://doi.org/10.1007/s12325-023-02738-0
M3 - Article
C2 - 38110653
SN - 0741-238X
JO - Advances in therapy
JF - Advances in therapy
ER -