PMID- 35993803 OWN - NLM STAT- MEDLINE DCOM- 20230120 LR - 20230413 IS - 1468-3083 (Electronic) IS - 0926-9959 (Print) IS - 0926-9959 (Linking) VI - 37 IP - 2 DP - 2023 Feb TI - Impact of blood involvement on efficacy and time to response with mogamulizumab in mycosis fungoides and Sezary syndrome. PG - 311-316 LID - 10.1111/jdv.18549 [doi] AB - BACKGROUND: Cutaneous T-cell lymphomas (CTCL) are rare types of non-Hodgkin lymphoma, which present in skin. Mycosis fungoides (MF) and Sezary syndrome (SS) are subtypes which make up two-thirds of all CTCL cases. The phase 3 MAVORIC study (NCT01728805) compared mogamulizumab to vorinostat in MF and SS patients, with post hoc data showing a trend for higher efficacy in mogamulizumab-treated patients as baseline blood tumour burden increases. OBJECTIVES: The aim of this study was to use updated post hoc analyses in order to examine the efficacy of mogamulizumab and vorinostat in MF patients when stratified by baseline blood involvement and to determine what factors affect time-to-global and time-to-skin response to inform clinical follow-up. METHODS: Post hoc analyses were carried out using data from MAVORIC. Overall response rate (ORR), progression-free survival (PFS) and time-to-next-treatment (TTNT) data were used to assess efficacy in patients with MF. Time-to-global response (TTR) was examined by disease subtype, by blood involvement in MF patients, and time-to-skin response was examined by blood involvement in MF patients. RESULTS: Numerically superior results were seen for ORR, PFS and TTNT in mogamulizumab-treated patients with MF compared with vorinostat, with a trend for outcomes improving with increasing baseline blood class. Statistically significant results for mogamulizumab compared with vorinostat were seen for MF B1 pts for PFS (8.43 vs. 2.83 months, p = 0.003) and TTNT (11.9 vs. 3.13 months, p = 0.002), and for MF B2 pts for ORR (46.2 vs. 9.1 months, p = 0.033). CONCLUSIONS: In mogamulizumab-treated MF patients, ORR and PFS were seen to improve with increasing blood involvement, which led to improved TTNT. TTR was more predictable for mogamulizumab-treated MF patients with blood involvement, and skin response may take longer than previously reported in some patients. CI - (c) 2022 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 - Beylot-Barry, Marie AU - Beylot-Barry M AUID- ORCID: 0000-0001-6150-1229 AD - University of Bordeaux, UMR 1312 INSERM, Bordeaux, France. AD - Dermatology Department, CHU Bordeaux, Bordeaux, France. FAU - Booken, Nina AU - Booken N AD - Department of Dermatology and Venereology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. FAU - Weishaupt, Carsten AU - Weishaupt C AUID- ORCID: 0000-0003-1195-2106 AD - Department of Dermatology, University Hospital of Muenster, Muenster, Germany. FAU - Scarisbrick, Julia AU - Scarisbrick J AD - University Hospital Birmingham, Birmingham, UK. FAU - Wu, Wende AU - Wu W AD - Kyowa Kirin, Inc, Princeton, New Jersey, USA. FAU - Rosen, Jan-Paul AU - Rosen JP AD - Kyowa Kirin International, Buckinghamshire, UK. FAU - Medley, Michael C AU - Medley MC AUID- ORCID: 0000-0001-8663-5821 AD - Kyowa Kirin International, Buckinghamshire, UK. LA - eng GR - Kyowa Kirin/ PT - Clinical Trial PT - Journal Article DEP - 20220830 PL - England TA - J Eur Acad Dermatol Venereol JT - Journal of the European Academy of Dermatology and Venereology : JEADV JID - 9216037 RN - YI437801BE (mogamulizumab) RN - 58IFB293JI (Vorinostat) SB - IM MH - Humans MH - *Lymphoma, T-Cell, Cutaneous/pathology MH - *Mycosis Fungoides/drug therapy/pathology MH - *Sezary Syndrome/drug therapy/pathology MH - *Skin Neoplasms/drug therapy/pathology MH - Vorinostat/therapeutic use PMC - PMC10087984 COIS- MBB has performed a consulting or advisory role for Kyowa Kirin and Recordati. She has also received travel expenses from Kyowa Kirin and Recordati. NB has received honoraria from Kyowa Kirin and Recordati. She has also performed a consulting or advisory role for Kyowa Kirin. She has also received travel expenses from Kyowa Kirin, Recordati and Takeda. CW has received honoraria from Bristol Meyer Squibb, Kyowa Kirin, and Merck Sharp and Dohme. He has also received travel expenses from Bristol Meyer Squibb. He has also performed an advisory role for Bristol Meyer Squibb, Kyowa Kirin, and Merk Sharp and Dohme. He has also performed a work group leadership role for Nationale Versorgungskonferenz Hautkrebs (NVKH). JS has received consulting fees from Codiak, Kyowa Kirin, Takeda, Therakos, Recordati and Helsinn. She also has performed an advisory role for Affimed Therapeutics and Codiak. WW, J-PR and MCM are employees of Kyowa Kirin, Inc. EDAT- 2022/08/23 06:00 MHDA- 2023/01/18 06:00 PMCR- 2023/04/11 CRDT- 2022/08/22 09:33 PHST- 2022/02/28 00:00 [received] PHST- 2022/08/05 00:00 [accepted] PHST- 2022/08/23 06:00 [pubmed] PHST- 2023/01/18 06:00 [medline] PHST- 2022/08/22 09:33 [entrez] PHST- 2023/04/11 00:00 [pmc-release] AID - JDV18549 [pii] AID - 10.1111/jdv.18549 [doi] PST - ppublish SO - J Eur Acad Dermatol Venereol. 2023 Feb;37(2):311-316. doi: 10.1111/jdv.18549. Epub 2022 Aug 30.