Imfinzi: how long were the pivotal tox studies?

“Two GLP repeat-dose IV toxicity studies were conducted with durvalumab, a 4-week (Study VMM0008) and a 13-week (Study VMM0033) repeat-dose toxicity study.”

“in both studies a loading dose (double the maintenance dose) of 30, 60, or 200 mg/kg durvalumab was administered on Day 1, and followed by 4 or 13 weekly doses of 15, 30, or 100 mg/kg, respectively.”

“The IV route of administration was used for all in vivo toxicology studies as this is the intended route of administration.”