Penile Cancer...Preferred Regimen...Pembrolizumab, if unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumor that has progressed following prior treatment and no satisfactory alternative treatment options or if tumor mutational burden-high (TMB-H), TMB ≥ 10mut/mb, in patients who have progressed on previously approved lines of therapy.

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:...for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

The first patient is a 64 year old male with PSCC who was treated with neoadjuvant chemotherapy, partial penectomy, and adjuvant radiation prior to developing metastatic disease. He had a high TMB (14 mutations/Mb) and was started on pembrolizumab with a complete response, which has been maintained for 38 months.