ORR is defined as the proportion of patients whose best overall disease response was either CR or PR during the combination treatment period based on blinded independent central radiology review.

per protocol set, participants with measure

per protocol set, participants with measure

per protocol set, participants with measure

Number of participants with progression free survival events

per protocol set, participants with measure

OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, OS was censored at the date of last contact including survival follow-up.

per protocol set, participants with measure

number of participants with confirmed positive ADA

immunogenicity set, participants with measure

C max

For descriptive purposes only, no hypothesis testing

pharmacokinetic analysis set 1, participants with measure

C through

For descriptive purposes only, no hypothesis testing

pharmacokinetic analysis set 1, participants with measure

AUEC (0-21d)

For descriptive purposes only, no hypothesis testing

Pharmnacodynamic analysis set, participants with measure

On treatment deaths were collected from the start of treatment up to 30 days after study drug discontinuation, for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days) Deaths post treatment survival follow up were collected after the on- treatment period, up to 3 years.

clinical data base population - treated patients