PMID- 34273208
OWN - NLM
STAT- MEDLINE
DCOM- 20211015
LR  - 20220721
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Print)
IS  - 0926-9959 (Linking)
VI  - 35
IP  - 11
DP  - 2021 Nov
TI  - Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a 
      post hoc analysis of the MAVORIC trial.
PG  - 2225-2238
LID - 10.1111/jdv.17523 [doi]
AB  - BACKGROUND: Mogamulizumab was compared with vorinostat in the phase 3 MAVORIC 
      trial (NCT01728805) in 372 patients with relapsed/refractory mycosis fungoides 
      (MF) or Sezary syndrome (SS) who had failed >/=1 prior systemic therapy. 
      Mogamulizumab significantly prolonged progression-free survival (PFS), with a 
      superior objective response rate (ORR) vs. vorinostat. OBJECTIVES: This post hoc 
      analysis was performed to evaluate the effect of baseline blood tumour burden on 
      patient response to mogamulizumab. METHODS: PFS, ORR, time to next treatment 
      (TTNT), skin response (modified Severity-Weighted Assessment Tool [mSWAT]) and 
      safety were assessed in patients stratified by blood classification (B0 
      [n = 126], B1 [n = 62], or B2 [n = 184], indicating increasing blood 
      involvement). RESULTS: Investigator-assessed PFS was longer for mogamulizumab 
      versus vorinostat across all blood classes, significantly so for B1 and B2 
      patients. ORR was higher with mogamulizumab than with vorinostat in all blood 
      classification groups and more markedly so with escalating B class (B0: 15.6% vs. 
      6.5%, P = 0.0549; B1: 25.8% vs. 6.5%, P = 0.2758; B2: 37.4% vs. 3.2%, 
      P < 0.0001). TTNT was significantly longer for patients treated with 
      mogamulizumab versus vorinostat with B1 (12.63 vs. 3.07 months; HR 0.32 [95% CI 
      0.16-0.67]; P = 0.0018) and B2 (13.07 vs. 3.53 months; HR 0.30 [95% CI 
      0.21-0.43]; P < 0.0001) blood involvement. In the mogamulizumab arm, 81 patients 
      (43.5%) had >/=50% change in the mSWAT vs. 41 patients (22.0%) with vorinostat; 
      mSWAT improvements with mogamulizumab occurred most often in B1 and B2 patients. 
      Rapid, sustained reductions were seen in CD4(+) CD26(-) cell counts and CD4:CD8 
      ratios in mogamulizumab patients for all B classes. Treatment-emergent adverse 
      events were less frequent overall with mogamulizumab and similar in frequency 
      regardless of B class. CONCLUSIONS: This post hoc analysis indicates greater 
      clinical benefit with mogamulizumab vs. vorinostat in patients with MF and SS 
      classified as having B1 and B2 blood involvement.
CI  - (c) 2021 The Authors. Journal of the European Academy of Dermatology and 
      Venereology published by John Wiley & Sons Ltd on behalf of European Academy of 
      Dermatology and Venereology.
FAU - Cowan, R A
AU  - Cowan RA
AUID- ORCID: 0000-0001-9004-8136
AD  - Christie Hospital Foundation NHS Trust, University of Manchester, Manchester, UK.
FAU - Scarisbrick, J J
AU  - Scarisbrick JJ
AD  - University Hospital Birmingham, Birmingham, UK.
FAU - Zinzani, P L
AU  - Zinzani PL
AD  - IRCCS Azienda Ospedaliero, Universitaria di Bologna, Bologna, Italia.
AD  - Istituto di Ematologia 'Seragnoli', Dipartimento di Medicina Specialistica, 
      Diagnostica e Sperimentale Universita degli Studi, Bologna, Italia.
FAU - Nicolay, J P
AU  - Nicolay JP
AD  - University Medical Centre Mannheim, Mannheim, Germany.
FAU - Sokol, L
AU  - Sokol L
AD  - Moffitt Cancer Center, Tampa, FL, USA.
FAU - Pinter-Brown, L
AU  - Pinter-Brown L
AD  - Chao Family Comprehensive Cancer Center, University of California-Irvine, Orange, 
      CA, USA.
FAU - Quaglino, P
AU  - Quaglino P
AUID- ORCID: 0000-0003-4185-9586
AD  - University of Turin, Turin, Italy.
FAU - Iversen, L
AU  - Iversen L
AD  - Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.
FAU - Dummer, R
AU  - Dummer R
AUID- ORCID: 0000-0002-2279-6906
AD  - Universitats Spital Zurich, Zurich, Switzerland.
FAU - Musiek, A
AU  - Musiek A
AD  - Division of Dermatology, Washington University in Saint Louis, St. Louis, 
      Missouri, USA.
FAU - Foss, F
AU  - Foss F
AD  - Hematology and Stem Cell Transplantation, Yale School of Medicine, New Haven, 
      Connecticut, USA.
FAU - Ito, T
AU  - Ito T
AD  - Kyowa Kirin Pharmaceutical Development, Inc., Princeton, NJ, USA.
FAU - Rosen, J-P
AU  - Rosen JP
AD  - Kyowa Kirin International, Buckinghamshire, UK.
FAU - Medley, M C
AU  - Medley MC
AD  - Kyowa Kirin International, Buckinghamshire, UK.
LA  - eng
GR  - Kyowa Kirin/
PT  - Journal Article
DEP - 20210820
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - YI437801BE (mogamulizumab)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized
MH  - Humans
MH  - *Mycosis Fungoides
MH  - Neoplasm Recurrence, Local
MH  - *Skin Neoplasms
MH  - Tumor Burden
PMC - PMC9290719
EDAT- 2021/07/18 06:00
MHDA- 2021/10/16 06:00
PMCR- 2022/07/18
CRDT- 2021/07/17 17:07
PHST- 2021/03/24 00:00 [received]
PHST- 2021/07/02 00:00 [accepted]
PHST- 2021/07/18 06:00 [pubmed]
PHST- 2021/10/16 06:00 [medline]
PHST- 2021/07/17 17:07 [entrez]
PHST- 2022/07/18 00:00 [pmc-release]
AID - JDV17523 [pii]
AID - 10.1111/jdv.17523 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2021 Nov;35(11):2225-2238. doi: 10.1111/jdv.17523. 
      Epub 2021 Aug 20.