Pembrolizumab for advanced penile cancer: a case series from a phase II basket trial

• DOI: 10.1007/s10637-021-01100-x
• Publication Date: 2021-03-26T07:02:46Z
• Authors: Andrew W. Hahn; Jad Chahoud; Matthew T. Campbell; Daniel D. Karp; Jennifer Wang; Bettzy Stephen; Shi-Ming Tu; Curtis A. Pettaway; Aung Naing
• Keywords: Male; Patient Acuity; Antibodies, Monoclonal, Humanized; 3. Good health; 03 medical and health sciences; Antineoplastic Agents, Immunological; 0302 clinical medicine; Carcinoma, Squamous Cell; Humans; Neoplasm Metastasis; Neoplasm Recurrence, Local; Penile Neoplasms; Aged

Treatment options for unresectable, locally advanced or metastatic penile squamous cell carcinoma (SCC) are limited. Previous studies have shown that 40-62% of patients with penile SCC express PD-L1. We report three cases of locally advanced or metastatic penile SCC treated with pembrolizumab.Herein, we present three patients with recurrent, locally advanced or metastatic penile SCC who progressed on a platinum-based chemotherapy triplet and were treated with pembrolizumab, administered as part of a phase II clinical trial for rare tumors (NCT02721732). One patient with a microsatellite instability high (MSI-H) tumor experienced a durable partial response to pembrolizumab, underwent surgical consolidation, and remains disease-free 38.7 months later. Two patients experienced progressive disease within 3 months of beginning pembrolizumab. No one experienced a grade 3 or worse treatment-related adverse event.In sum, single-agent pembrolizumab was well tolerated as salvage therapy in a small cohort of patients with unresectable, locally advanced or metastatic penile SCC. Pembrolizumab produced an objective response in an MSI-H tumor, yet it did not control disease in two patients with MSS penile SCC. Rationale combination therapies, including pembrolizumab, warrant further investigation.ClinicalTrials.gov identifier: NCT02721732 . Registered March 23, 2016.