Study endpoints during the phase 1b dose escalation
death
DISEASE, SECONDARY, INV
The primary objectives in the dose-escalation cohort were to evaluate safety and tolerability and to determine any DLTs, the MTD and the RP2D of mosunetuzumab in combination with polatuzumab vedotin 1.8 mg/kg. The secondary objectives were anti-tumor activity, determined by measuring the complete response rate at the time of PRA based on PET-CT; best ORR (complete response or partial response at any time) on study, based on PET and/or CT scan; and DoR, defined as the time from the first occurrence of a documented ORR to progressive disease or relapse or death from any cause, whichever occurred first. Response was determined by the INV using Lugano 2014 criteria