Background Treatment options for penile squamous cell carcinoma (PeCa) are limited. We sought to investigate clinical outcomes and safety profiles of patients with PeCa receiving immune checkpoint inhibitors (ICIs). Methods This retrospective study included patients with locally advanced or metastatic PeCa receiving ICIs during 2015-2022 across 24 centers in the United States, Europe, and Asia. Overall survival (OS) and progression-free survival (PFS) were estimated by the Kaplan-Meier method. Objective response rates (ORRs) were determined per RECIST 1.1 criteria. Treatment-related adverse events (trAEs) were graded per the Common Terminology Criteria for Adverse Events v5.0. Two-sided statistical tests were used for comparisons. Results Among 92 patients, 8 were Asian (8.7%), 6 (6.5%) were Black, and 24 (29%) were Hispanic/Latinx. Median age was 62 (inter-quartile range: 53 to 70) years. 83 (90%) had metastatic PeCa, and 74 (80%) received ≥2nd line treatment. Most patients received pembrolizumab monotherapy (n = 26, 28%), combination nivolumab/ipilimumab +/- multi-targeted tyrosine kinase inhibitors (n = 23, 25%), nivolumab (n = 16, 17%) or cemiplimab (n = 15, 16%) monotherapies. Median OS and PFS were 9.8 (95% CI: 7.7-12.8) months and 3.2 (95% CI: 2.5-4.2) months, respectively. ORR was 13% (n = 11/85) in the overall cohort and 35% (n = 7/20) in patients with lymph node-only metastases. Visceral metastases, ECOG performance status ≥1, and higher Neutrophil/Lymphocyte ratio (NLR) were associated with worse OS. TrAEs occurred in 29% (n = 27) and 9.8% (n = 9) were grade ≥3. Conclusions ICIs are active in a subset of patients with PeCa. Future translational studies are warranted to identify patients more likely to derive clinical benefit from ICIs.

An older man from the mid-Southeastern USA presented with acute onset of fever, fatigue, and non-bloody diarrhoea. There was high suspicion for tick-borne illness given exposure history, clinical presentation and laboratory abnormalities. Despite prompt treatment with doxycycline, the patient clinically worsened. He was diagnosed with secondary hemophagocytic lymphohistiocytosis (HLH) due to Heartland virus (HRTV). This is the second documented case of secondary HLH due to HRTV, and the first in a relatively immunocompetent patient. Furthermore, though HRTV has been primarily concentrated in the Central USA, our case provides evidence of further geographic expansion of HRTV, mirroring the increased range of the Lone Star tick. Clinicians should consider HRTV when a patient with a clinical presentation consistent with tick-borne illness fails to respond to doxycycline. Furthermore, healthcare providers should be aware of the geographic expansion of HRTV and the potential of HRTV to lead to secondary HLH.

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