PMID- 36967244
OWN - NLM
STAT- MEDLINE
DCOM- 20230425
LR  - 20230425
IS  - 2152-2669 (Electronic)
IS  - 2152-2669 (Linking)
VI  - 23
IP  - 5
DP  - 2023 May
TI  - Comparative Efficacy of Teclistamab Versus Physician's Choice of Therapy in the 
      Long-term Follow-up of APOLLO, POLLUX, CASTOR, and EQUULEUS Clinical Trials in 
      Patients With Triple-class Exposed Relapsed or Refractory Multiple Myeloma.
PG  - 385-393
LID - S2152-2650(23)00061-7 [pii]
LID - 10.1016/j.clml.2023.02.006 [doi]
AB  - BACKGROUND: The efficacy and safety of teclistamab in patients with RRMM who 
      received >/=3 prior lines of therapy and were triple-class exposed (TCE) are being 
      evaluated in the single-arm, multicohort, phase I/II MajesTEC-1 trial 
      (NCT04557098). We evaluated the comparative effectiveness of teclistamab versus 
      physician's choice (PC) of therapy in TCE RRMM patients. METHODS: Individual 
      patient-level data from MajesTEC-1 patients who received teclistamab (1.5 mg/kg 
      weekly; clinical cutoff March 16, 2022) were included. An external control arm 
      was created from patients in long-term follow-up of 4 clinical trials of 
      daratumumab who were treated with PC therapy after discontinuation of trial 
      treatments. In the primary analysis, inverse probability of treatment weighting 
      was used to adjust for imbalances in 9 baseline covariates. A fully adjusted 
      model included 5 additional prognostic factors. Outcomes included overall 
      response rate (ORR), very good partial response or better (>/=VGPR) rate, overall 
      survival (OS), progression-free survival (PFS), and time to next treatment 
      (TTNT). RESULTS: After adjustment, baseline characteristics were balanced between 
      cohorts. In the primary analysis, outcomes were significantly improved with 
      teclistamab versus PC: ORR (OR [95% CI] 4.81 [3.04-7.72]; P < .0001); >/=VGPR rate 
      (OR, 12.07 [6.91-22.11]; P < .0001); OS (HR, 0.54 [0.40-0.73]; P < .0001); PFS 
      (HR, 0.59 [0.46-0.78]; P = .0001); and TTNT (HR, 0.32 [0.24-0.42]; P < .0001). 
      Results of the fully adjusted model were consistent with the primary analysis. 
      CONCLUSION: Teclistamab showed significantly improved effectiveness versus PC on 
      all outcomes, highlighting its clinical benefit in patients with TCE RRMM and 
      limited treatment options.
CI  - Copyright (c) 2023 Elsevier Inc. All rights reserved.
FAU - Mateos, Maria-Victoria
AU  - Mateos MV
AD  - University Hospital of Salamanca/IBSAL/CIC, Salamanca, Spain. Electronic address: 
      mvmateos@usal.es.
FAU - Chari, Ajai
AU  - Chari A
AD  - Mount Sinai School of Medicine, New York, NY.
FAU - Usmani, Saad Z
AU  - Usmani SZ
AD  - Memorial Sloan Kettering Cancer Center, New York, NY.
FAU - Goldschmidt, Hartmut
AU  - Goldschmidt H
AD  - University Hospital Heidelberg, Heidelberg, Germany.
FAU - Weisel, Katja
AU  - Weisel K
AD  - University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
FAU - Qi, Keqin
AU  - Qi K
AD  - Janssen Research & Development, Titusville, NJ.
FAU - Londhe, Anil
AU  - Londhe A
AD  - Janssen Research & Development, Titusville, NJ.
FAU - Nair, Sandhya
AU  - Nair S
AD  - Janssen Pharmaceutica NV, Beerse, Belgium.
FAU - Lin, Xiwu
AU  - Lin X
AD  - Janssen Research & Development, Spring House, PA.
FAU - Pei, Lixia
AU  - Pei L
AD  - Janssen Research & Development, Raritan, NJ.
FAU - Ammann, Eric
AU  - Ammann E
AD  - Janssen Global Services, Raritan, NJ.
FAU - Kobos, Rachel
AU  - Kobos R
AD  - Janssen Research & Development, Raritan, NJ.
FAU - Smit, Jennifer
AU  - Smit J
AD  - Janssen Research & Development, Spring House, PA.
FAU - Parekh, Trilok
AU  - Parekh T
AD  - Janssen Research & Development, Bridgewater, NJ.
FAU - Marshall, Alexander
AU  - Marshall A
AD  - Janssen Global Services, Raritan, NJ.
FAU - Slavcev, Mary
AU  - Slavcev M
AD  - Janssen Global Services, Raritan, NJ.
FAU - Moreau, Philippe
AU  - Moreau P
AD  - University Hospital Hotel-Dieu, Nantes, France.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
DEP - 20230303
PL  - United States
TA  - Clin Lymphoma Myeloma Leuk
JT  - Clinical lymphoma, myeloma & leukemia
JID - 101525386
RN  - 0 (Antineoplastic Agents)
RN  - 7S5I7G3JQL (Dexamethasone)
SB  - IM
MH  - Humans
MH  - *Antineoplastic Agents/therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Dexamethasone/therapeutic use
MH  - Follow-Up Studies
MH  - *Multiple Myeloma/drug therapy
MH  - *Physicians
MH  - Progression-Free Survival
OTO - NOTNLM
OT  - B-cell maturation antigen
OT  - Bispecific antibody
OT  - Comparative effectiveness
OT  - Indirect treatment comparison
OT  - MajesTEC-1
EDAT- 2023/03/27 06:00
MHDA- 2023/04/21 06:41
CRDT- 2023/03/26 23:01
PHST- 2022/11/23 00:00 [received]
PHST- 2023/01/27 00:00 [revised]
PHST- 2023/02/16 00:00 [accepted]
PHST- 2023/04/21 06:41 [medline]
PHST- 2023/03/27 06:00 [pubmed]
PHST- 2023/03/26 23:01 [entrez]
AID - S2152-2650(23)00061-7 [pii]
AID - 10.1016/j.clml.2023.02.006 [doi]
PST - ppublish
SO  - Clin Lymphoma Myeloma Leuk. 2023 May;23(5):385-393. doi: 
      10.1016/j.clml.2023.02.006. Epub 2023 Mar 3.