Bavencio: which tox species, and why?

“Thus, the toxicity of avelumab was evaluated in a GLP-compliant, 13-week toxicology study in cynomolgus monkeys.”

“The cynomolgus monkey was, however, a pharmacologically relevant species for toxicity testing based on a similar avelumab binding affinity to cynomolgus monkey and human PD-L1 and the comparable cross-reactivity of avelumab across cynomolgus monkey and human tissues.”

“Avelumab shows similar binding affinity for human, mouse and cynomolgus PD-L1.”

“Thus, the toxicity of avelumab was evaluated in a GLP-compliant, 13-week toxicology study in cynomolgus monkeys.”

“Reproductive and developmental toxicology studies were not conducted with avelumab. Instead, the Applicant submitted a non-product specific literature based assessment of the potential for avelumab to affect reproduction.”

“Not conducted per ICH S6, ICH S1, and ICH S9.”

“Avelumab shows similar binding affinity for human, mouse and cynomolgus PD-L1.”