Atezolizumab With or Without Radiotherapy for Advanced Squamous Cell Carcinoma of the Penis (The PERICLES Study): A Phase II Trial
Hielke M. de Vries, Tynisha S. Rafael, Alberto Gil-Jimenez, Jeantine M. de Feijter, Elise M. Bekers, Elsbeth van der Laan, Marta López‐Yurda, Erik Hooijberg, Annegien Broeks, Dennis Peters, Iris M. Seignette, Floris J. Pos, Simon Horenblas, Bas W.G. van Rhijn, Ekaterina S. Jordanova, Oscar R. Brouwer, Eva Schaake, Michiel S. van der Heijden
Abstract
PURPOSE: Patients with advanced penile squamous cell carcinoma have a poor prognosis (21% 2-year overall survival [OS] from diagnosis). We assessed the activity of atezolizumab (anti-PD-L1) in patients with advanced penile cancer, with or without radiotherapy (RT). PATIENTS AND METHODS: A single-center, nonrandomized phase II study with two treatment arms was conducted in 32 patients with histologically confirmed advanced penile cancer. All patients received atezolizumab (1,200 mg) once every 3 weeks. Twenty patients, who were expected to benefit from RT for locoregional disease control, received additional irradiation. The primary end point was 1-year progression-free survival (PFS) for the complete cohort and was reached if the actual 1-year PFS was at least 35%. Secondary end points included OS, objective response rate (ORR), and tolerability. Exploratory biomarker analyses were conducted in pretreatment specimens. RESULTS: = .037). CONCLUSION: T-cell infiltration, may help to better select responders.