AstraZeneca announces results from CAPItello-281 trial

Results from the CAPItello-281 Phase III trial showed that AstraZeneca’s (AZN) Truqap in combination with abiraterone and androgen deprivation therapy, or ADT, demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival, or rPFS, versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer, or mHSPC. Overall survival, or OS, data were immature at the time of this analysis; however, the Truqap combination showed an early trend towards an OS improvement versus abiraterone and ADT with placebo. The trial will continue as planned to further assess OS as a key secondary endpoint. The safety profile of Truqap in combination with abiraterone and ADT in CAPItello-281 was broadly consistent with the known profile of each medicine. Data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.