Loqtorzi: how long were the pivotal tox studies?

“The FDA agrees that there were no toripalimab-related adverse effects up to doses of 100 mg/kg on male or female cynomolgus monkeys treated once weekly for 26 weeks.”

“In the 4-week GLP-compliant (Q2W) repeat- dose study (10, 30, 100 mg/kg) with a 7-week recovery period, toripalimab was well tolerated at doses up to 100 mg/kg.”

“Monkeys received intravenous toripalimab once weekly at doses of 0, 10, 30, and 100 mg/kg.”