Comparative Effectiveness of Teclistamab Versus Real-World Physician's Choice of Therapy in LocoMMotion and MoMMent in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma.

LocoMMotion MajesTEC-1 MoMMent Relapsed or refractory multiple myeloma Teclistamab Triple-class exposed

Journal

Advances in therapy
ISSN: 1865-8652
Titre abrégé: Adv Ther
Pays: United States
ID NLM: 8611864

Informations de publication

Date de publication:
19 Dec 2023
Historique:
received: 06 10 2023
accepted: 14 11 2023
medline: 19 12 2023
pubmed: 19 12 2023
entrez: 19 12 2023
Statut: aheadofprint

Résumé

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. 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). 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). Teclistamab demonstrated significantly improved effectiveness over RWPC in LocoMMotion ± MoMMent, emphasizing its clinical benefit as a highly effective treatment for patients with TCE RRMM. MajesTEC-1, ClinicalTrials.gov NCT03145181 (phase 1) and NCT04557098 (phase 2); LocoMMotion, ClinicalTrials.gov NCT04035226; MoMMent, ClinicalTrials.gov NCT05160584.

Identifiants

pubmed: 38110653
doi: 10.1007/s12325-023-02738-0
pii: 10.1007/s12325-023-02738-0
doi:

Banques de données

ClinicalTrials.gov
['NCT05160584', 'NCT04557098', 'NCT04035226', 'NCT03145181']

Types de publication

Journal Article

Langues

eng

Informations de copyright

© 2023. The Author(s).

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Auteurs

Philippe Moreau (P)

Hematology Clinic, University Hospital Hotel-Dieu, Nantes, France.

María-Victoria Mateos (MV)

University Hospital of Salamanca/IBSAL/CIC/CIBERONC, Salamanca, Spain.

Maria Esther Gonzalez Garcia (ME)

University Hospital Cabueñes, Gijón, Spain.

Hermann Einsele (H)

Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany.

Valerio De Stefano (V)

Section of Hematology, Catholic University, Fondazione Policlinico A. Gemelli, IRCCS, Rome, Italy.

Lionel Karlin (L)

Centre Hospitalier Lyon Sud, Pierre-Bénite, France.

Joanne Lindsey-Hill (J)

Nottinghamshire University Hospitals NHS Trust, Nottingham, UK.

Britta Besemer (B)

University of Tübingen, Tübingen, Germany.

Laure Vincent (L)

Centre Hospitalier Universitaire de Montpellier, Montpellier, France.

Suriya Kirkpatrick (S)

University of the West of England, Bristol, England, UK.

Michel Delforge (M)

University of Leuven, Leuven, Belgium.

Aurore Perrot (A)

Centre Hospitalier Universitaire de Toulouse, Oncopole, Toulouse, France.

Niels W C J van de Donk (NWCJ)

Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Charlotte Pawlyn (C)

The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.

Salomon Manier (S)

CHU Lille, University of Lille, Lille, France.

Xavier Leleu (X)

CHU Poitiers, Poitiers, France.

Joaquin Martinez-Lopez (J)

Hematología Hospital 12 de Octubre, Madrid, Spain.

Francesca Ghilotti (F)

Janssen-Cilag SpA, Cologno Monzese, Italy.

Joris Diels (J)

Janssen Pharmaceutica NV, Beerse, Belgium.

Raúl Morano (R)

Janssen-Cilag, Madrid, Spain.

Claire Albrecht (C)

Janssen-Cilag, Issy-les-Moulineaux, France.

Vadim Strulev (V)

Janssen Pharmaceutica NV, Beerse, Belgium.

Imène Haddad (I)

Janssen-Cilag, Issy-les-Moulineaux, France.

Lixia Pei (L)

Janssen Research & Development, Raritan, NJ, USA.

Rachel Kobos (R)

Janssen Research & Development, Raritan, NJ, USA.

Jennifer Smit (J)

Janssen Research & Development, Spring House, PA, USA.

Mary Slavcev (M)

Janssen Global Services, Raritan, NJ, USA.

Alexander Marshall (A)

Janssen Research & Development, Raritan, NJ, USA.

Katja Weisel (K)

University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany. k.weisel@uke.de.

Classifications MeSH