Pembrolizumab

A single-arm phase II trial (KEYNOTE-629 [NCT03284424]) enrolled 105 patients into the cohort of recurrent or metastatic SCC.[6] Patients were required to have measurable disease and were excluded for an autoimmune disease or a medical condition requiring immunosuppression or an Eastern Cooperative Oncology Group Performance Status above grade 1. Treatment continued for up to 2 years in the absence of disease progression, unacceptable toxicity, or investigator or patient decision to withdraw. If stable, patients with radiological-only evidence of progressive disease at first assessment were permitted to continue treatment until progressive disease was confirmed. The primary end point was RR per RECIST v1.1.

A single-arm phase II trial (KEYNOTE-629 [NCT03284424]) enrolled 105 patients into the cohort of recurrent or metastatic SCC.[6] Patients were required to have measurable disease and were excluded for an autoimmune disease or a medical condition requiring immunosuppression or an Eastern Cooperative Oncology Group Performance Status above grade 1. Treatment continued for up to 2 years in the absence of disease progression, unacceptable toxicity, or investigator or patient decision to withdraw. If stable, patients with radiological-only evidence of progressive disease at first assessment were permitted to continue treatment until progressive disease was confirmed. The primary end point was RR per RECIST v1.1.

An interim analysis at 11 months of follow-up (range, 0.4−16.3 months) demonstrated an RR of 34% (95% CI, 25%−44%) with four CRs. Median duration of response has not been reached (range, 3−13± months).

A single-arm phase II trial (KEYNOTE-629 [NCT03284424]) enrolled 105 patients into the cohort of recurrent or metastatic SCC.[6] Patients were required to have measurable disease and were excluded for an autoimmune disease or a medical condition requiring immunosuppression or an Eastern Cooperative Oncology Group Performance Status above grade 1. Treatment continued for up to 2 years in the absence of disease progression, unacceptable toxicity, or investigator or patient decision to withdraw. If stable, patients with radiological-only evidence of progressive disease at first assessment were permitted to continue treatment until progressive disease was confirmed. The primary end point was RR per RECIST v1.1.

Exploratory analysis of programmed death ligand 1 combined positive score by immunohistochemistry did not predict response to treatment.

A single-arm phase II trial (KEYNOTE-629 [NCT03284424]) enrolled 105 patients into the cohort of recurrent or metastatic SCC.[6] Patients were required to have measurable disease and were excluded for an autoimmune disease or a medical condition requiring immunosuppression or an Eastern Cooperative Oncology Group Performance Status above grade 1. Treatment continued for up to 2 years in the absence of disease progression, unacceptable toxicity, or investigator or patient decision to withdraw. If stable, patients with radiological-only evidence of progressive disease at first assessment were permitted to continue treatment until progressive disease was confirmed. The primary end point was RR per RECIST v1.1.

Adverse events were consistent with PD-1 inhibitors. Treatment-emergent adverse events led to discontinuation in 13 patients (12%); five (5%) were considered treatment-emergent adverse events, including pneumonitis, cranial nerve neuropathy, and renal failure. Grade 5 treatment-emergent adverse events occurred in 12 patients (11%) and included infection, cardiac failure, and respiratory failure. One death from cranial nerve neuropathy was considered treatment related.