A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer

The rPFS is defined as the time from the date of randomization to the date of first documented PD per Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever occurs first.

ORR is defined as the number of participants who have a best overall response of confirmed complete response (CR) or partial response (PR) without prior confirmed bone progression

DoR is the time from the date of initial tumor response (CR or PR) to the date of first disease progression or death from any cause, whichever occurs first.

TTR is defined as the time from the start of treatment to the first objective response (CR or PR).

PSA50 response is defined as a ≥ 50% decline in PSA from baseline with confirmation at least 3 weeks after the first documented reduction in PSA of ≥ 50%.

PSA90 response is defined as a ≥ 90% decline in PSA from baseline with confirmation at least 3 weeks after the first documented reduction in PSA of ≥ 90%.

Time to PSA progression is defined as the time from the date of randomization to the first documented PSA progression.

Duration of PSA response is defined as the time from the date of first PSA response to the earliest date of PSA progression.

OS is defined as the time from the date of randomization to the date of death from any cause.

Time to first SSE is defined as the time from the date of randomization to the first occurrence of SSE from any cause.

Time to pain progression is defined as the time interval from randomization to the first date a participant experiences pain progression. Higher scores indicate more severe pain.

The BPI-sf pain severity score consists of 4 items that assess pain at its worst, least, average, and current pain intensity. The pain severity score is the average of the 4 item scores. Higher scores indicate more severe pain.

The BPI-sf pain interference score includes 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The pain interference score is the average of the 7 interference items. Higher scores indicate more interference from pain in daily life.

The FACT-P consists of 27 items from the Functional Assessment of Cancer Therapy-General (FACT-G) that measure physical, social/family, emotional, and functional well-being and 12 items that compose the Prostate Cancer Subscale (PCS). Higher scores indicate greater impact of prostate cancer on daily life.

Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs leading to study treatment discontinuation

The highest measured concentration of lorigerlimab in the bloodstream.

AUC is the total amount of lorigerlimab in bloodstream after drug administration

Trough concentration is the concentration measured before a subsequent dose of lorigerlimab

Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time

The volume of distribution is related to how much drug is distributed to body tissues, or remains in the bloodstream.

Terminal elimination half-life is the time it takes for the concentration of the drug in plasma or serum to be reduced by 50%