Cemiplimab

A phase I expansion cohort trial (NCT02383212) that required patients to have at least one measurable lesion enrolled patients with metastatic (n = 16) or locally advanced (n = 10) SCC. Cemiplimab was administered as 3 mg/kg IV over 30 minutes every 2 weeks.[4]

A phase I expansion cohort trial (NCT02383212) that required patients to have at least one measurable lesion enrolled patients with metastatic (n = 16) or locally advanced (n = 10) SCC. Cemiplimab was administered as 3 mg/kg IV over 30 minutes every 2 weeks.[4]

Formal hypothesis testing was not included in phase I. However, responses, as assessed by an independent review committee, were seen in 13 of 26 patients using Response Evaluation Criteria In Solid Tumors (RECIST) criteria for radiological scans.[4]

A phase II trial (NCT02760498) entered patients into one of two cohorts: patients with metastatic SCC (nodal or distant; 59 patients) [4] or patients with locally advanced SCC who were not eligible for local surgery or radiation therapy (78 patients).[5]Patients were required to have at least one measurable lesion and were excluded for an autoimmune disease that required systemic therapy within 5 years, previous checkpoint inhibitor therapy, solid organ transplant, Eastern Cooperative Oncology Group performance status below 1, and hepatitis or infection with HIV. Patients received treatment with 3 mg/kg IV every 2 weeks until progressive disease. RRs were assessed by an independent review committee using RECIST criteria for radiological scans and World Health Organization criteria for medical photography for a composite response. RRs were assessed after all patients had at least 6 months of follow-up.

A phase II trial (NCT02760498) entered patients into one of two cohorts: patients with metastatic SCC (nodal or distant; 59 patients) [4] or patients with locally advanced SCC who were not eligible for local surgery or radiation therapy (78 patients).[5]Patients were required to have at least one measurable lesion and were excluded for an autoimmune disease that required systemic therapy within 5 years, previous checkpoint inhibitor therapy, solid organ transplant, Eastern Cooperative Oncology Group performance status below 1, and hepatitis or infection with HIV. Patients received treatment with 3 mg/kg IV every 2 weeks until progressive disease. RRs were assessed by an independent review committee using RECIST criteria for radiological scans and World Health Organization criteria for medical photography for a composite response. RRs were assessed after all patients had at least 6 months of follow-up.

Metastatic disease: Twenty-eight of 59 patients had a response (47%; 95% CI, 34%−61%); 4 patients (7%) had a CR. The median duration of follow-up was 7.9 months with median duration of response not reached. When results from the 16 patients with metastatic disease in the phase I study were pooled with the results from the 59 patients with metastatic disease in the phase II cohort, the RR in 75 patients remained 47% (95% CI, 35%−59%).

A phase II trial (NCT02760498) entered patients into one of two cohorts: patients with metastatic SCC (nodal or distant; 59 patients) [4] or patients with locally advanced SCC who were not eligible for local surgery or radiation therapy (78 patients).[5]Patients were required to have at least one measurable lesion and were excluded for an autoimmune disease that required systemic therapy within 5 years, previous checkpoint inhibitor therapy, solid organ transplant, Eastern Cooperative Oncology Group performance status below 1, and hepatitis or infection with HIV. Patients received treatment with 3 mg/kg IV every 2 weeks until progressive disease. RRs were assessed by an independent review committee using RECIST criteria for radiological scans and World Health Organization criteria for medical photography for a composite response. RRs were assessed after all patients had at least 6 months of follow-up.

Locally advanced disease: A total of 78 patients with locally advanced disease (i.e., no nodal metastases) were enrolled in the phase II cohort. The RR was 44% (34 patients; 95% CI, 32−55), with CRs reported in 10 patients (13%). The median duration of follow-up was 9.3 months at the time of data cut-off, with a median duration of response not reached.

A phase II trial (NCT02760498) entered patients into one of two cohorts: patients with metastatic SCC (nodal or distant; 59 patients) [4] or patients with locally advanced SCC who were not eligible for local surgery or radiation therapy (78 patients).[5]Patients were required to have at least one measurable lesion and were excluded for an autoimmune disease that required systemic therapy within 5 years, previous checkpoint inhibitor therapy, solid organ transplant, Eastern Cooperative Oncology Group performance status below 1, and hepatitis or infection with HIV. Patients received treatment with 3 mg/kg IV every 2 weeks until progressive disease. RRs were assessed by an independent review committee using RECIST criteria for radiological scans and World Health Organization criteria for medical photography for a composite response. RRs were assessed after all patients had at least 6 months of follow-up.

Exploratory immunohistochemistry analysis did not show predictive value of baseline PD-L1.

A phase II trial (NCT02760498) entered patients into one of two cohorts: patients with metastatic SCC (nodal or distant; 59 patients) [4] or patients with locally advanced SCC who were not eligible for local surgery or radiation therapy (78 patients).[5]Patients were required to have at least one measurable lesion and were excluded for an autoimmune disease that required systemic therapy within 5 years, previous checkpoint inhibitor therapy, solid organ transplant, Eastern Cooperative Oncology Group performance status below 1, and hepatitis or infection with HIV. Patients received treatment with 3 mg/kg IV every 2 weeks until progressive disease. RRs were assessed by an independent review committee using RECIST criteria for radiological scans and World Health Organization criteria for medical photography for a composite response. RRs were assessed after all patients had at least 6 months of follow-up.

Adverse events were consistent with PD-1 inhibitors. In the phase II trial, approximately 7% to 8% of patients discontinued treatment because of adverse events, and there were five treatment-emergent adverse events leading to death.