Tecentriq: which tox species, and why?

“The Applicant conducted repeat-dose toxicology studies in mice and Cynomolgus monkeys.”

“In vitro pharmacology studies demonstrated that atezolizumab binds to human, murine, and Cynomolgus monkey PD-L1”

“To minimize immunogenicity in mice, the Applicant generated two mouse IgG2a chimeric antibodies (PRO304397 and PRO314483), containing the binding region of atezolizumab.”

“General toxicology studies evaluated atezolizumab in mice for two weeks and in Cynomolgus monkeys for up to 26 weeks.”

“Reproductive and developmental toxicity studies have not been conducted with atezolizumab. However, in the chronic toxicity study in sexually mature monkeys, atezolizumab treatment at the high-dose resulted in irregular menstrual cycles and a lack of newly formed corpora lutea in the ovaries.”

“Carcinogenicity studies have not been conducted in accordance with ICH S6(R1) and ICH S9.”

“To minimize immunogenicity in mice, the Applicant generated two mouse IgG2a chimeric antibodies (PRO304397 and PRO314483), containing the binding region of atezolizumab.”