▎WuXiEdited by Kant Content Team

AstraZeneca today announced positive results from the CAPItello-281 Phase 3 clinical trial. Analysis shows that for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC), AstraZeneca's Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) compared to abiraterone and ADT plus placebo,Showed statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS).According to the press release, the Truqap combination is the first AKT inhibitor combination proven to be beneficial for this specific subtype of prostate cancer.

Prostate cancer is the second most common cancer in men and the fifth leading cause of cancer death in men worldwide. Statistics show that only one-third of patients with metastatic prostate cancer survive within five years of diagnosis. mHSPC is a malignant tumor with a poor prognosis and low survival rate. Approximately 200,000 patients are diagnosed with mHSPC each year, and one-quarter of these patients have PTEN-deficient tumors, which carry an especially poor prognosis.

At the time of this analysis, the overall survival (OS) data were not yet mature;However, Truqap combination therapy showed an early trend of OS improvement compared to the placebo group.The trial will continue as planned to further evaluate the results of the key secondary endpoint OS. The safety of Truqap in the CAPItello-281 trial, when used in combination with abiraterone and ADT, is generally consistent with the known safety profiles of each drug.

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Truqap is a selective, targeted ATP-competitive inhibitor of three AKT kinase isoforms (AKT1/2/3).This oral medication is being tested in numerous clinical trials for the treatment of tumors with PI3K/AKT/PTEN signaling pathway mutations. In November last year, the therapyFDA ApprovedUsed in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

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References:

[1] Truqap combination in PTEN-deficient metastatic hormone-sensitive prostate cancer demonstrated statistically significant and clinically meaningful improvement in radiographic progression-free survival in CAPItello-281 Phase III trial. Retrieved November 25, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2024/truqap-improved-rpfs-in-advanced-prostate-cancer.html

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