TY - JOUR
T1 - Pembrolizumab for advanced penile cancer
T2 - a case series from a phase II basket trial
AU - Hahn, Andrew W.
AU - Chahoud, Jad
AU - Campbell, Matthew T.
AU - Karp, Daniel D.
AU - Wang, Jennifer
AU - Stephen, Bettzy
AU - Tu, Shi Ming
AU - Pettaway, Curtis A.
AU - Naing, Aung
N1 - Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
PY - 2021/10
Y1 - 2021/10
N2 - Background: 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. Case Presentations: 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. Conclusion: 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. Trial registration: ClinicalTrials.gov identifier: NCT02721732. Registered March 23, 2016.
AB - Background: 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. Case Presentations: 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. Conclusion: 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. Trial registration: ClinicalTrials.gov identifier: NCT02721732. Registered March 23, 2016.
KW - Locally advanced
KW - MSI-high
KW - Pembrolizumab
KW - Penile squamous cell carcinoma
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U2 - 10.1007/s10637-021-01100-x
DO - 10.1007/s10637-021-01100-x
M3 - Article
C2 - 33770291
AN - SCOPUS:85103358273
SN - 0167-6997
VL - 39
SP - 1405
EP - 1410
JO - Investigational New Drugs
JF - Investigational New Drugs
IS - 5
ER -