Alternative pembrolizumab dosing schedule safe, effective in metastatic melanoma

Source: Healio, April 2020

An alternative pembrolizumab dosing regimen of 400 mg every 6 weeks appeared safe and effective for patients with metastatic melanoma, according to first clinical outcomes data from KEYNOTE-555 cohort B presented at the virtual American Association for Cancer Research Annual Meeting.

“Pembrolizumab [Keytruda, Merck] is approved globally in multiple cancer indications at a dose of 200 mg or 2 mg/kg every 3 weeks,” Mallika Lala, PhD, associate principal scientist at Merck & Co., said during a presentation. “An alternative dosing regimen of 400 mg every 6 weeks is proposed as an additional option to the currently approved dose, which provides convenience and flexibility to patients and providers — the need for which is particularly exemplified by the current COVID-19 pandemic. We selected this alternative dose based upon pharmacokinetic and exposure-response modeling and simulation data that formed the basis of its approval in markets including the European Union, Australia and New Zealand.”

The open-label KEYNOTE-555 cohort B study was designed to evaluate the alternative dosing schedule among 100 patients (mean age, 64 years; 59.1% men; mean body weight, 85 kg) with metastatic melanoma. Investigators sought to validate model-based assessments, as well as determine efficacy and safety of the 6-week regimen compared with historical data.