Keytruda: which tox species, and why?

“consisted of pivotal 1-month and 6-month repeat-dose chronic toxicity studies both with 4-month recovery periods in Cynomolgus monkey”

“Its binding affinities to PD-1 derived from human and cynomolgus monkeys were comparable (~2X difference), however, the antibody did not bind to rodent or dog PD-1.”

“Given the lack of cross-reactivity of MK-3475 with murine PD-1, a commercially available hamster anti-murine PD-1 mAb, J43, was used as surrogate for in vivo pharmacology studies.”

“consisted of pivotal 1-month and 6-month repeat-dose chronic toxicity studies both with 4-month recovery periods in Cynomolgus monkey”

“Dedicated nonclinical studies investigating the effects of pembrolizumab on embryofetal development are not warranted at this time to support its use in the intended patient population.”

“Carcinogenicity studies were not required to support the licensing application for a product to treat advanced human cancer and are neither planned nor expected as post-marketing requirements at this time.”

“Given the lack of cross-reactivity of MK-3475 with murine PD-1, a commercially available hamster anti-murine PD-1 mAb, J43, was used as surrogate for in vivo pharmacology studies.”