Journal Article Clinical Trial, Phase II Multicenter Study Ppublish
PubMed: 40319676 DOI: 10.1016/j.ejca.2025.115484
Phase II trial of atezolizumab (Anti-PD-L1) in the treatment of relapsed/refractory IIB/IVB mycosis fungoides/Sézary syndrome patients after previous systemic treatment. EORTC-1652-CLTG "PARCT".
Eur J Cancer 222:115484
Authors: Rudolf Stadler, Gabriele Roccuzzo, Pablo Ortiz-Romero, Martine Bagot, Pietro Quaglino, Emmanuella Guenova, Constanze Jonak, Evangelia Papadavid, René Stranzenbach, Sandrine Marreaud, Jammbe Musoro, Jose Casas-Martin, Duncan Murray, Samantha Drennan, Jimmy Van Hear, Paul Moss, Delphine Sartori, Maxime Battistella, Rein Willemze, Julia Scarisbrick, Robert Knobler
Affiliations
- University Clinic for Dermatology, Ruhr University of Bochum, Minden, Germany.
- Department of Medical Sciences, Section of Dermatology, University of Turin, Turin, Italy.
- Department of Dermatology, Hospital Universitario 12 de Octubre, Institute i+ 12, University Complutense, Madrid, Spain.
- Department of Dermatology, Hôpital Saint-Louis, Université Paris Cité, Paris, France.
- Department of Medical Sciences, Section of Dermatology, University of Turin, Turin, Italy.
- Department of Dermatology, Lausanne University Hospital (CHUV) and Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland; University Institute and Clinic for Immunodermatology, Medical Faculty, Johannes Kepler University, Linz, Austria.
- Department of Dermatology, Medical University of Vienna, Vienna, Austria.
- Second Department of Dermatology, National and Kapodistrian University of Athens, Athens, Greece.
- Department of Dermatology, St. Josef Hospital, UK RUB, Bochum, Germany.
- EORTC Headquarters, Brussels, Belgium.
- Department of Haematology, University Hospitals Coventry and Warwickshire and Institute of Immunology and Immunotherapy, University of Birmingham, United Kingdom.
- Department of Immunology and Immunotherapy, College of Medicine and Health, University of Birmingham, United Kingdom.
- Department of Pathology, Hôpital Saint-Louis, AP-HP, Université Paris Cité, Inserm U976, Paris, France.
- Department of Dermatology, Leiden University Medical Center, the Netherlands.
- Department of Dermatology, University Hospital Birmingham, Birmingham, United Kingdom.
Abstract
INTRODUCTION
Treatment of advanced mycosis fungoides (MF) and Sézary syndrome (SS) is a challenge. In this international, multicenter, open-label phase II trial, we assessed the efficacy and safety of anti-PD-L1 atezolizumab in stage IIB-IV refractory/relapsed MF and SS.
MATERIALS AND METHODS
Patients received atezolizumab 1200 mg IV Q3w for up to 1 year unless progression or withdrawal. The main study endpoints were overall response rate (ORR), progression-free survival (PFS), time to next systemic treatment (TTNT), and overall survival (OS).
RESULTS
A total of 26 patients were enrolled from seven countries. Seventeen patients met the inclusion criteria. At a median follow-up of 36.6 months, the ORR was 15.4 % in the intention to treat (ITT) and 17.6 % in the per protocol (PP) population, respectively. In the PP group, 58.8 % of patients, and in the ITT group, 53.9 % of patients achieved partial response or stable disease as their best outcome. One complete response was observed after 1 year. Median PFS was 3 months (95 % CI 1.4-4.9) in PP and 3.1 months (95 % CI 2.4-4.0) in ITT. Median OS was not reached for PP and was 22.3 months (20.0-NE) for ITT. Median TTNT was 5.9 months (2.8-NE) in PP and 6.2 months (3.1-14.8) in ITT. The most common grade ≥ 3 adverse events were fatigue (23.1 %) and infections (15.4 %), with two sepsis-related deaths. Atezolizumab was primarily discontinued due to disease progression (50 %).
CONCLUSIONS
Atezolizumab shows moderate activity in pretreated refractory/relapsed MF and SS. Further studies are needed to identify reliable predictors of safety and treatment response.
MeSH
Mycosis Fungoides, Safety, Sezary Syndrome, Neoplasms, Therapeutics