Response to brentuximab vedotin versus physician's choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis.

Mycosis fungoides (MF), the most common type of cutaneous T-cell lymphoma, can lead to disfiguring lesions, debilitating pruritus and frequent skin infections. This study assessed response to brentuximab vedotin in patients with MF in the phase III ALCANZA study. Baseline CD30 levels and large-cell transformation (LCT) status were centrally reviewed in patients with previously-treated CD30-positive MF using ≥2 skin biopsies obtained at screening; eligible patients required ≥1 biopsy with ≥10% CD30 expression. Patients were categorised as CD30 Clinical activity with brentuximab vedotin was observed across all CD30 expression levels in patients with ≥1 biopsy showing ≥10% CD30 expression. Superior ORR4 was observed with brentuximab vedotin versus physician's choice in patients: with CD30 These exploratory analyses demonstrated that brentuximab vedotin improved rates of ORR4 and PFS versus physician's choice in patients with CD30-positive MF and ≥1 biopsy showing ≥10% CD30 expression, regardless of LCT status. Clinicaltrials.gov, NCT01578499.

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Déclaration de conflit d'intérêts

Conflict of interest statement Y.H.K. reports advisory roles for Seagen and Takeda. H.M.P. reports advisory board for and grants or funds from Takeda. D.F. reports advisory roles for Kyowa Kirin. S.M.H. reports consulting fees from ADC Therapeutics, C4 Therapeutics, Celgene, Janssen, Kura Oncology, Kyowa Hakko Kirin, Myeloid Therapeutics, Seagen, Takeda, Verastem and Vividion Therapeutics, and research grants or funds from ADC Therapeutics, Aileron, Celgene, Daiichi Sankyo, Forty Seven, Inc., Kyowa Hakko Kirin, Millennium/Takeda, Portola Pharmaceuticals, Seagen, Trillium Therapeutics and Verastem. M.D. reports research funding from Takeda and Millennium for this study, Seagen for a physician IST, and institutional funding from Solenginex, miragene, Rhizen and Eisai. O.B. reports consulting fees from Novartis, BMS, Sanofi, Pierre, Fabre and MSD. J.A.S. reports speaker’s bureau, and consultancy/advisory roles for Takeda (Brazil). J.S. reports consulting fees from/Clinical Expert for Takeda. P.Q. reports advisory boards and speaker fee for Takeda, Kiowa, Therakos, Miragen, Helsinn-Recordati, Innate Pharma, 4SC and Actelion. P.L.Z. reports advisory roles for and honoraria from Merck, BMS, Servier, Takeda, TG Therapeutics, ADC Therapeutics, Abbvie, Incyte, Janssen, Gilead, Eusapharma, Roche, Debiopharm and Novartis. H.E. reports advisory roles for Abbvie and Genentech, honoraria from Abbvie, Genentech, Takeda and Pharmacyclics, grants or funds from Abbvie, Genentech, Pharmacyclics, Acerta, Celgene and Astrazeneca. L.C.P-B. reports advisory roles for and honoraria from Seagen. P.L.O-R. reports advisory roles for Takeda, Helsinn, 4SC, Actelion, Innate Pharma, Recordati Rare Diseases, Kyowa and miRagen, grants or funds from MEDA, and PLCG1 mutation patent. O.E.A. reports advisory roles for Trillium Therapeutics, Bioniz, Kyowa Kirin and Meivir, and research grants or funds from Actelion, Adaptive Biotechnology, Trillium Therapeutics, Pfizer and Kyowa Kirin. J.T. reports research funding from Takeda, Celgene, Roche, Beigene, Janssen and PCYC. M.W. reports honoraria from Takeda and Kyowa Kirin, and research grants or funds from Millennium. J.W. reports advisory roles for Roche, Celgene, Takeda, Janssen-Cilag, Servier, Amgen, BMS, Abbvie, Novartis and Gilead, honoraria from Roche, Celgene, Takeda, Janssen-Cilag, Servier, Amgen, Abbvie, Gilead and Novartis, grants or funds from Roche, GSK/Novartis, Takeda and Janssen-Cilag, and conference travel support from Roche. A.A.G. reports advisory roles for Seagen, Innate Pharma and StemLine Therapeutics, honoraria and grants or funds from StemLine Therapeutics, and consultancy fees from Innate Pharma and StemLine. L.B. reports employment for Zymeworks. M.C.P-W., J.L. and M.O. report employment for and ownership of stocks/shares from Seagen. V.B. reports employment for Takeda Pharmaceuticals. M.L. reports employment for and ownership of stocks/shares from Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd. W.L.T. reports employment for and ownership of stocks/shares from Takeda Pharmaceuticals. R.D. reports intermittent, project focused consulting and/or advisory relationships with Novartis, Merck Sharp & Dhome (MSD), Bristol-Myers Squibb (BMS), Roche, Amgen, Takeda, Pierre Fabre, Sun Pharma, Sanofi, Catalym, Second Genome, Regeneron and Alligator. S.W., R.S., P.W., K.T., and M.M. have no conflicts of interest to disclose.