Pembrolizumab monotherapy

The FDA approval of pembrolizumab monotherapy was based on data from 149 patients with MSI-H or dMMR cancers enrolled across five uncontrolled, multicohort, multicenter, single-arm clinical trials. Ninety patients had colorectal cancer, and 59 patients were diagnosed with 1 of 14 other cancer types. Patients received either 200 mg of pembrolizumab every 3 weeks or 10 mg/kg of pembrolizumab every 2 weeks. Treatment continued until unacceptable toxicity or disease progression occurred. The major efficacy outcome measures were objective response rate (assessed by blinded independent central radiologists’ review in accordance with Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and response duration.

The FDA approval of pembrolizumab monotherapy was based on data from 149 patients with MSI-H or dMMR cancers enrolled across five uncontrolled, multicohort, multicenter, single-arm clinical trials. Ninety patients had colorectal cancer, and 59 patients were diagnosed with 1 of 14 other cancer types. Patients received either 200 mg of pembrolizumab every 3 weeks or 10 mg/kg of pembrolizumab every 2 weeks. Treatment continued until unacceptable toxicity or disease progression occurred. The major efficacy outcome measures were objective response rate (assessed by blinded independent central radiologists’ review in accordance with Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and response duration.

The objective response rate was 39.6% (95% CI, 31.7%–47.9%).

The FDA approval of pembrolizumab monotherapy was based on data from 149 patients with MSI-H or dMMR cancers enrolled across five uncontrolled, multicohort, multicenter, single-arm clinical trials. Ninety patients had colorectal cancer, and 59 patients were diagnosed with 1 of 14 other cancer types. Patients received either 200 mg of pembrolizumab every 3 weeks or 10 mg/kg of pembrolizumab every 2 weeks. Treatment continued until unacceptable toxicity or disease progression occurred. The major efficacy outcome measures were objective response rate (assessed by blinded independent central radiologists’ review in accordance with Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and response duration.

Responses lasted 6 months or longer for 78% of patients who responded to pembrolizumab. There were 11 complete responses and 48 partial responses.

The FDA approval of pembrolizumab monotherapy was based on data from 149 patients with MSI-H or dMMR cancers enrolled across five uncontrolled, multicohort, multicenter, single-arm clinical trials. Ninety patients had colorectal cancer, and 59 patients were diagnosed with 1 of 14 other cancer types. Patients received either 200 mg of pembrolizumab every 3 weeks or 10 mg/kg of pembrolizumab every 2 weeks. Treatment continued until unacceptable toxicity or disease progression occurred. The major efficacy outcome measures were objective response rate (assessed by blinded independent central radiologists’ review in accordance with Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and response duration.

The objective response rate was similar whether patients were diagnosed with colorectal cancer (36%) or a different cancer (46% across the 14 other cancer types).