Efficacy and safety of mogamulizumab by patient blood classification
Scarisbrick, J. Zinzani, P. L. Nicolay, J. P. Caballero, D. Sokol, L. Pinter-Brown, L Rosen, J. P.
Scarisbrick, J.
Zinzani, P. L.
Nicolay, J. P.
Caballero, D.
Sokol, L.
Pinter-Brown, L
Rosen, J. P.
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Abstract
Cutaneous T-cell lymphomas (CTCLs) are rare, serious and potentially life-threatening
forms of non-Hodgkin lymphoma that primarily present in skin.
Mycosis fungoides (MF) and S ezary syndrome (SS) are the classic
subtypes and together account for around two-thirds of all CTCLs.
Initial methods of disease staging in MF and SS built upon the
tumour-node-metastasis (TNM) classification using disease-specific
findings. Blood classification (B0–2) was added to staging in 2007
based upon the recognition of blood involvement as a prognostic
factor; increasing blood tumour burden has previously been linked
with worsening of overall survival (OS) and disease-specific survival
(DSS), and an increased risk of disease progression (RDP) (Agar
2010, Am Soc J Clin Oncol), although this is a subject of debate and
further study. Patients with B1 disease have previously been shown
to have a median survival of just 3.2 years, similar to B2 for which it
was 3.1 years (Agar 2010, Am Soc J Clin Oncol). The addition of
blood classification allows for more specific disease staging which
may inform clinical management strategy, whilst also contributing to
a better understanding of prognostic factors and treatment response
in MF and SS. This post hoc analysis from the MAVORIC trial examined
the efficacy and safety of mogamulizumab (MOGA) compared
with vorinostat (VORI), stratified by patient blood classification.
Materials & Methods: MAVORIC (NCT01728805) was an openlabel,
phase 3 study where patients were randomized 1:1 to receive
either intravenous MOGA 1.0 mg/kg weekly for the first 28 day cycle, then on days 1 and 15 of subsequent cycles, or oral VORI 400
mg once daily. VORI patients who experienced disease progression
or intolerable toxicity could cross over to MOGA. The primary endpoint
was investigator-assessed progression-free survival (PFS).
Results: In MAVORIC, investigator-assessed PFS was significantly
longer for MOGA than VORI overall at 7.7 months and 3.1 months,
respectively (P < 0.0001). When data were stratified by blood classification,
PFS was found to be significantly superior for MOGA as
compared to VORI in patients with both B1 and B2 disease
(Table 1). Overall response rate (ORR) was also significantly greater
for MOGA than VORI in MAVORIC at 28.0% and 4.8%, respectively
(P < 0.0001), and was found in this analysis to be significantly
greater for MOGA than VORI in those patients with B2 disease
(Table 1). ORR for B1 was not significant, but showed a trend
(25.8% vs. 6.5% for MOGA and VORI, respectively). Time-to-nexttreatment
(TTNT) was not significant for patients without blood
involvement (B0), but was significantly greater for MOGA in patients
with blood involvement (B1 or B2) with 13.07 and 3.30 months for
MOGA and VORI, respectively (P < 0.0001) (Table 1). Drug-related
treatment-emergent adverse events (TEAEs) were similar in patients
regardless of blood involvement and were lower for MOGA than
VORI at each blood classification level (Table 1).
Conclusion: MOGA is effective in patients with blood involvement
(B1 and B2), often showing a greater clinical benefit in patients in
the B1 and B2 groups than those in the B0 group. Drug safety is
similar between patients irrespective of level of blood involvement.
Affiliation
Description
Date
2021
Publisher
Collections
Keywords
Type
Meetings and Proceedings
Citation
Scarisbrick J, Zinzani PL, Cowan R, Nicolay JP, Caballero D, Sokol L, et al. Efficacy and safety of mogamulizumab by patient blood classification. British Journal of Haematology. 2021;193:49.