AstraZeneca's (AZN.US) Truqap combination therapy shows positive results in its Phase 3 trial
1min read As of today, AstraZeneca (AZN.US) announced positive results from the Phase 3 CAPItello-281 trial of its Trugap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) versus abiraterone and ADT with placebo in patients with PTEN deficient metastatic hormone-sensitive prostate cancer (mHSPC). The analysis showed a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS). According to reports, the Trugap combination is the first AKT inhibitor combination proven to be beneficial for this specific subtype of prostate cancer.
OS data were not mature at the time of this analysis; however, an early trend of OS improvement was observed with the Trugap combination versus placebo. The trial will continue as planned to further assess the results of the key secondary endpoint OS. The safety profile of Trugap in combination with abiraterone and ADT in the CAPItello-281 trial was generally consistent with the known safety profile of each drug.
Trugap is an ATP-competitive inhibitor of three AKT kinase isoforms (AKT1/2/3). The oral drug is being tested in many clinical programs for tumors with mutations in the PI3K/AKT/PTEN signaling pathway. Last November, the therapy was approved by the FDA for use in combination with fulvestrant for the treatment of adult patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer.