Efficacy and Safety of Topical Hypericin Photodynamic Therapy for Early-Stage Cutaneous T-Cell Lymphoma (Mycosis Fungoides)

• DOI: 10.1001/jamadermatol.2022.2749
• Publication Date: 2022-07-20T15:02:30Z
• Authors: Ellen J. Kim; Aaron R. Mangold; Jennifer A. DeSimone; Henry K. Wong; Lucia Seminario-V...; Joan Guitart; James Appel; Larisa Geskin; Edward Lain; Neil J. Korman; Nathalie Zeitouni; Neda Nikbakht; Kenneth Dawes; Oleg Akilov; Joi Carter; Michi Shinohara; Timothy M. Kuzel; Warren Piette; Neal Bhatia; Amy Musiek; David Pariser; Youn H. Kim; Dirk Elston; Erin Boh; Madeleine Duvic; Auris Huen; Theresa Pacheco; Jeffrey P. Zwerner; Seung Tae Lee; Michael Girardi; Christiane Querfeld; Kimberly Bohjanen; Elise Olsen; Gary S. Wood; Adam Rumage; Oreola Donini; Andrea Haulenbeek; Christopher J. Sc...; Richard Straube; Christopher Pullion; Alain H. Rook; Brian Poligone
• Keywords: Cutaneous T-cell lymphoma; Tolerability; Clinical endpoint

Given that mycosis fungoides-cutaneous T-cell lymphoma (MF/CTCL) is chronic, there a need for additional therapies with minimal short- and long-term adverse effects. Topical synthetic hypericin ointment, 0.25%, activated visible light novel, nonmutagenic photodynamic therapy (PDT).To determine the efficacy safety of topical as PDT in early-stage MF/CTCL.This was multicenter, placebo-controlled, double-blinded, phase 3 randomized clinical trial (FLASH study) conducted from December 2015 to November 2020 at 39 academic community-based US medical centers. Participants were adults (≥18 years) (IA-IIA) MF/CTCL.In cycle 1, patients 2:1 receive or placebo index lesions twice weekly 6 weeks. In 2, all received active drug weeks lesions. (optional), both weeks.The primary end point lesion response rate (ILRR), defined 50% greater improvement modified Composite Assessment Index Lesion Severity (mCAILS) score baseline after 1. For cycles 2 3, open label rates secondary points. Adverse events (AEs) assessed each treatment visit, cycle, then monthly months. Data analyses performed on 21, 2020.The study population comprised 169 (mean [SD] age, 58.4 [16.0] years; 96 [57.8%] men; 120 [72.3%] White individuals) MF/CTCL. After treatment, more effective than (cycle 1 ILRR, 16% vs 4%; P = .04). The ILRR increased 40% who (P < .001 hypericin) 49% hypericin). Significant responses observed patch plaque type similar regardless sex, race, stage IA IB, time since diagnosis, number prior therapies. most common treatment-related AEs mild local skin (13.5%-17.3% across 1-3 10.5% 1) application-site reactions (3.2%-6.9% 4% 1). No drug-related serious occurred.The findings this indicate MF/CTCL has favorable profile.ClinicalTrials.gov Identifier: NCT02448381.