Evidence map›Paper›PMID 36961654›Full record

Trial reportAdvances in therapy2023

Comparative Efficacy of Teclistamab Versus Current Treatments in Real-World Clinical Practice in the Prospective LocoMMotion Study in Patients with Triple-Class-Exposed Relapsed and/or Refractory Multiple Myeloma.

Philippe Moreau, Niels W C J van de Donk, Michel Delforge, Hermann Einsele, Valerio De Stefano, Aurore Perrot, Britta Besemer, Charlotte Pawlyn, Lionel Karlin, Salomon Manier and 12 more

2 registry-linked trialsOpen access · hybridAbstract readClinical TrialComparative Study
In one paragraph

Trial report in Advances in therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 20 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 3 pooled it
7.3field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04035226 completednot on this map

A Prospective, Multinational Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including PI, IMID, and CD38 Monoclonal Antibody Treatment

TypeobservationalSponsorJanssen-Cilag Ltd.Ran2019 to 2022Enrolled254ConditionsMultiple MyelomaArmsNo intervention
NCT04557098 phase2active not recruitingnot on this map

TECLIMMY1001-P3: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

TypeinterventionalSponsorJanssen Research & Development, LLCRan2020 to 2027Enrolled194ConditionsHematological MalignanciesArmsTeclistamab
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 17 institutions in 8 countries.

Philippe MoreauHematology Clinic, University Hospital Hôtel-Dieu, Nantes, France.
Niels W C J van de DonkDepartment of Hematology, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Michel DelforgeUniversity of Leuven, Leuven, Belgium.
Hermann EinseleMedizinische Klinik Und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany.
Valerio De StefanoSection of Hematology, Catholic University, Fondazione Policlinico A. Gemelli, IRCCS, Rome, Italy.
Aurore PerrotService d'Hématologie, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
Britta BesemerUniversity of Tübingen, Tübingen, Germany.
Charlotte PawlynThe Institute of Cancer Research, London, UK.
Lionel KarlinCentre Hospitalier Lyon Sud, Pierre-Bénite, France.
Salomon ManierUniversity of Lille, Lille, France.
Xavier LeleuCHU and University, Poitiers, France.
Katja WeiselUniversity Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Francesca GhilottiJanssen-Cilag SpA, Cologno Monzese, Italy.
Joris DielsJanssen Pharmaceutica NV, Beerse, Belgium.
Ahmed ElsadaJanssen-Cilag, High Wycombe, Buckinghamshire, UK.
Raul MoranoJanssen EMEA, Madrid, Spain.
Vadim StrulevJanssen Pharmaceutica NV, Beerse, Belgium.
Lixia PeiJanssen Research & Development, Raritan, NJ, USA.
Rachel KobosJanssen Research & Development, Raritan, NJ, USA.
Jennifer SmitJanssen Research & Development, Spring House, PA, USA.
Mary SlavcevJanssen Global Services, LLC, Raritan, NJ, USA.
Maria-Victoria MateosDepartamento de Hematología, University Hospital of Salamanca/IBSAL, CIC, Salamanca, Spain. mvmateos@usal.es.
Janssen (United States) · USJanssen (Belgium) · BEAgostino Gemelli University Polyclinic · ITCentre Hospitalier Universitaire de Poitiers · FRCentre Hospitalier Universitaire de Toulouse · FRHôpital Lyon Sud · FRHôtel-Dieu de Paris · FRInstitute of Cancer Research · GBInstituto de Investigación Biomédica de Salamanca · ESJanssen (Italy) · ITJanssen (United Kingdom) · GBKU Leuven · BEUniversitätsklinikum Würzburg · DEUniversité de Lille · FRUniversity Medical Center Hamburg-Eppendorf · DEUniversity of Tübingen · DEVrije Universiteit Amsterdam · NL

Funding

Cancer Research UK 29957
6 · The paper itself

Abstract

introductionPatients with triple-class-exposed relapsed/refractory multiple myeloma (TCE-RRMM) have a poor prognosis and limited treatment options. Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, was studied in patients with TCE-RRMM in the single-arm MajesTEC-1 study. To assess the relative effectiveness of teclistamab versus real-world physician's choice of therapy (RWPC), adjusted comparisons were performed using individual patient data from MajesTEC-1 and LocoMMotion, a prospective study of patients with TCE-RRMM.

methodsAn external control arm for MajesTEC-1 was created from patients in LocoMMotion (n = 248; clinical cut-off: November 2, 2021) and compared with treated patients (n = 165) from MajesTEC-1 (teclistamab 1.5 mg/kg weekly; clinical cut-off: March 16, 2022). Inverse probability weighting was used to adjust for imbalances in baseline covariates. For binary endpoints [overall response rate (ORR), very good partial response or better (≥ VGPR) rate, complete response or better (≥ CR)], relative effect of teclistamab versus RWPC was estimated with an odds ratio and relative response rate and 95% confidence interval (CI), derived from weighted logistic regression. Weighted Cox proportional hazards model was used to estimate hazard ratios (HR) and 95% CIs for time-to-event endpoints [duration of response (DOR), progression-free survival (PFS), and overall survival (OS)].

resultsAfter weighting, baseline characteristics were balanced across cohorts. In adjusted comparisons, teclistamab-treated patients were 2.3-fold, 5.2-fold and 148.3-fold, more likely to reach ORR [response-rate ratio (RR) = 2.31, 95% CI 1.77-2.85, p < 0.0001], ≥ VGPR (RR = 5.19, 95% CI 3.26-7.12, p < 0.0001) and ≥ CR (RR = 148.25, 95% CI 20.63-1065.40, p < 0.0001), respectively, versus patients receiving RWPC. Following adjustment, DOR (HR 0.32, 95% CI 0.19-0.54, p < 0.0001) and PFS (HR 0.48, 95% CI 0.35-0.65, p < 0.0001) were significantly longer with teclistamab versus RWPC. OS was numerically better with teclistamab versus RWPC [HR 0.77 (0.55-1.09), p = 0.1419].

conclusionTeclistamab demonstrated improved effectiveness versus RWPC, highlighting its clinical benefit as a novel and effective treatment for patients with TCE-RRMM.

trial registrationMajest TEC-1, ClinicalTrials.gov NCT04557098; LocoMMotion, ClinicalTrials.gov NCT04035226.

Indexed as

Antineoplastic AgentsMultiple MyelomaAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneHumansProspective StudiesRemission InductionTreatment OutcomeAntineoplastic AgentsDexamethasoneLocoMMotionMajesTEC-1TeclistamabTriple-class exposed relapsed or refractory multiple myeloma

Identifiers

PMID36961654
PMCPMC10129954
OpenAlexW4360806629

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.