Time to Next Treatment in Patients With Previously Treated Cutaneous T‐cell Lymphoma (Ctcl) Receiving Mogamulizumab or Vorinostat: A Post‐hoc Analysis of the Mavoric Study

Kim, Y.H.; Ortiz‐Romero, Pablo L.; Pro, Barbara; Sokol, Lubomir; Scarisbrick, J.; Musiek, Amy; Vermeer, Maarten H.; Dummer, Reinhard; Halwani, Ahmad; Fierro, Maria Teresa; Moriya, Junji; Leoni, Mollie; Bagot, Martine

doi:10.1002/hon.95_2630

Cited by 4 publications

(17 citation statements)

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“…Over the past 5 years, TTNT has been utilised and endorsed as a surrogate marker for DOCB in clinical studies of CTCL [2][3][4][5][6][7][8]. TTNT represents the interval from commencement of one treatment to initiation of the next line of therapy.…”

Section: Ttnt In Ctclmentioning

confidence: 99%

“…For the first time, TTNT has been recognised as a valid endpoint in prospective, randomised studies of CTCL [7,8]. These two international prospective trials have demonstrated the usefulness of TTNT to provide clinically meaningful assessment of treatment efficacy, considering differences in the toxicity profiles and modes of delivery, beyond the traditional markers of disease control.…”

Section: Ttnt In Published Prospective Clinical Studies In Ctclmentioning

confidence: 99%

“…In the second international phase 3 study (MAVORIC), 372 MF/SS patients were randomised to intravenous mogamulizumab or oral vorinostat, with crossover in the latter group upon disease progression or treatment-intolerance [7,16]. PFS was the primary endpoint, with superior median PFS seen in the group receiving mogamulizumab, 7.7 months (95% CI: 5.7-10.3) versus 3.1 months (95% CI: 2.9-4.1) in the vorinostat group (HR = 0.53; 95% CI: 0.41-0.69; p < 0.0001) [16].…”

Section: Ttnt In Published Prospective Clinical Studies In Ctclmentioning

confidence: 99%

“…Furthermore, TTNT offers a better reflection of the patients' treatment experiences than conventional disease-related endpoints by incorporating the time course of treatment tolerability and patient compliance. In clinical studies of CTCL, TTNT is used as an addition to conventional evaluation criteria and also as a stand-alone assessment of duration of treatment efficacy [2][3][4][5][6][7][8], but to date no standardised definition has been agreed. Herein, we review the use of TTNT in the published CTCL literature, and propose a new standardised definition that accounts for the unique characteristics and challenges of CTCL.…”

Section: Introductionmentioning

confidence: 99%

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Time to Next Treatment as a Meaningful Endpoint for Trials of Primary Cutaneous Lymphoma

Campbell

Scarisbrick

Kim

et al. 2020

Cancers

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Time to next treatment (TTNT) is an emerging endpoint in clinical studies of primary cutaneous T-cell lymphomas (CTCL), with utility as a surrogate marker for the “duration of clinical benefit”. TTNT provides a highly clinically meaningful endpoint that uniquely reflects not only the duration of treatment efficacy on disease and symptom control, but also incorporates the patient experience by accounting for patient compliance and tolerance to the studied therapy(s). Given the distinct challenges of pin-pointing the exact date of progression in patients with multi-compartmental CTCL, TTNT overcomes many of the shortcomings of conventional, disease-focused, clinical endpoints in primary CTCL research. Although widely accepted in clinical research for numerous other incurable malignancies, TTNT currently lacks a standardised definition. In this paper, we describe the value of TTNT as a clinical endpoint, review the applications of TTNT in primary CTCL research, and propose a standardised definition of TTNT to be applied in future clinical research of primary CTCL therapies.

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Section: Ttnt In Ctclmentioning

confidence: 99%

Section: Ttnt In Published Prospective Clinical Studies In Ctclmentioning

confidence: 99%

Section: Ttnt In Published Prospective Clinical Studies In Ctclmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Time to Next Treatment as a Meaningful Endpoint for Trials of Primary Cutaneous Lymphoma

Campbell

Scarisbrick

Kim

et al. 2020

Cancers

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“…Of note, vorinostat was the control arm of the MAVORIC study where a median progression‐free survival of 3·1 months [95% confidence interval (CI) 2·9–4·1 months] was reported . Moreover, a recent analysis of the MAVORIC study presented in abstract form demonstrated a TTNT of 3·5 months (95% CI 3·1–4·3 months] . These results are strikingly similar to our TTNT of 4 months and confirms the value of TTNT as a clinically meaningful end point, particularly in retrospective analyses of real‐world studies where detailed global response scoring as used in prospective clinical trials is not always feasible.…”

mentioning

confidence: 99%

A comparative analysis of histone deacetylase inhibitors for the treatment of mycosis fungoides and Sézary syndrome

et al. 2019

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Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial

Cowan

Scarisbrick

Zinzani

et al. 2021

Acad Dermatol Venereol

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Background Mogamulizumab was compared with vorinostat in the phase 3 MAVORIC trial (NCT01728805) in 372 patients with relapsed/refractory mycosis fungoides (MF) or S ezary 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 + CD26cell 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.

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Time to Next Treatment in Patients With Previously Treated Cutaneous T‐cell Lymphoma (Ctcl) Receiving Mogamulizumab or Vorinostat: A Post‐hoc Analysis of the Mavoric Study

Cited by 4 publications

References 0 publications

Time to Next Treatment as a Meaningful Endpoint for Trials of Primary Cutaneous Lymphoma

Time to Next Treatment as a Meaningful Endpoint for Trials of Primary Cutaneous Lymphoma

A comparative analysis of histone deacetylase inhibitors for the treatment of mycosis fungoides and Sézary syndrome

Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial

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