Imjudo: how long were the pivotal tox studies?

“Following repeat administration at doses up to 50 mg/kg for either 1‐month (5 doses) or 6‐months (26 doses), signs comprised intermittent diarrhea”

“The toxicokinetics of tremelimumab was evaluated in cynomolgus monkeys following IV administrations of tremelimumab in a single‐dose (10, 30, and 100 mg/kg), 1 month (5, 15, and 50 mg/kg/week;) and 6 month (5, 15, and 50 mg/kg/week) toxicologic studies”

“The Applicant evaluated the safety of tremelimumab administered intravenously, the intended route of administration, using cynomolgus monkeys in GLP‐compliant 1‐ and 6‐month repeat‐dose toxicology studies.”