Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial
dc.contributor.author | Cowan, Richard A | |
dc.contributor.author | Scarisbrick, J. J. | |
dc.contributor.author | Zinzani, P. L. | |
dc.contributor.author | Nicolay, J. P. | |
dc.contributor.author | Sokol, L. | |
dc.contributor.author | Pinter-Brown, L. | |
dc.contributor.author | Quaglino, P. | |
dc.contributor.author | Iversen, L. | |
dc.contributor.author | Dummer, R. | |
dc.contributor.author | Musiek, A. | |
dc.contributor.author | Foss, F. | |
dc.contributor.author | Ito, T. | |
dc.contributor.author | Rosen, J. P | |
dc.contributor.author | Medley, M. C. | |
dc.date.accessioned | 2021-08-17T12:22:44Z | |
dc.date.available | 2021-08-17T12:22:44Z | |
dc.date.issued | 2021 | en |
dc.identifier.citation | Cowan R, Scarisbrick JJ, Zinzani PL, Nicolay JP, Sokol L, Pinter‐Brown L, et al. Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial. Journal of the European Academy of Dermatology and Venereology. 2021 Jul 17. | en |
dc.identifier.pmid | 34273208 | en |
dc.identifier.doi | 10.1111/jdv.17523 | en |
dc.identifier.uri | http://hdl.handle.net/10541/624446 | |
dc.description.abstract | Background: Mogamulizumab was compared with vorinostat in the phase 3 MAVORIC trial (NCT01728805) in 372 patients with relapsed/refractory mycosis fungoides (MF) or Sézary syndrome (SS) who had failed ≥1 prior systemic therapy. Mogamulizumab significantly prolonged progression-free survival (PFS), with a superior objective response rate (ORR) versus 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 versus 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 versus vorinostat in patients with MF and SS classified as having B1 and B2 blood involvement. | en |
dc.language.iso | en | en |
dc.relation.url | https://dx.doi.org/10.1111/jdv.17523 | en |
dc.title | Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial | en |
dc.type | Article | en |
dc.contributor.department | Christie Hospital Foundation NHS Trust, University of Manchester, UK. | en |
dc.identifier.journal | Journal of the European Academy of Dermatology and Venereology | en |
dc.description.note | en] |