Positive CAPItello-281 Phase III trial for AstraZeneca

UK pharma major AstraZeneca (LSE: AZN) today released positive high-level results from the CAPItello-281 Phase III trial showing that its Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically-significant and clinically-meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).

Overall survival (OS) data were immature at the time of this analysis; the company said. 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 positive outcome was welcomed as, earlier this year the CAPItello-290 Phase III trial for Truqap missed its goal. The company noted that Truqap in combination with paclitaxel in patients with locally advanced (inoperable) or metastatic triple-negative breast cancer (TNBC) did not meet the dual primary endpoints of improvement in overall survival (OS) versus paclitaxel in combination with placebo