AstraZeneca: Truqap Combination In Phase III Trial Shows Improvement In Advanced Prostate Cancer

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(RTTNews) - British drug maker AstraZeneca Plc (AZN.L, AZN) announced Monday positive high-level results from CAPItello-281 Phase III trial of Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy or ADT in PTEN-deficient metastatic hormone-sensitive prostate cancer.

The company noted that the Truqap combination in advanced prostate cancer demonstrated statistically significant and clinically meaningful improvement in radiographic progression-free survival or rPFS in the trial.

It is the first and only AKT inhibitor combination to demonstrate benefit in this specific subtype of prostate cancer, the firm noted.

Prostate cancer is the second most prevalent cancer in men and the fifth leading cause of male cancer death across the globe. Metastatic prostate cancer is associated with a significant mortality rate, with only one third of patients surviving five years after diagnosis.

Truqap, which is discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics, is a first-in-class, potent, adenosine triphosphate or ATP-competitive inhibitor of all three AKT isoforms.

CAPItello-281 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of Truqap in combination with abiraterone and ADT versus abiraterone and ADT in combination with placebo in the treatment of patients with PTEN-deficient de novo mHSPC.

In the trial, overall survival 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.

In the trial, the safety profile of Truqap in combination with abiraterone and ADT in CAPItello-281 was broadly consistent with the known profile of each medicine.

The company plans to present the data at a forthcoming medical meeting and to share with global regulatory authorities.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, "These results show for the first time, that adding an AKT inhibitor to a standard-of-care therapy can provide benefit to patients with a biomarker of PTEN-deficient metastatic hormone-sensitive prostate cancer. By targeting a key driver of the disease, we have been able to improve upon current therapies and demonstrate the potential role of this combination in an area of critical unmet need. It will be important to see greater maturity in key secondary endpoints including overall survival."

Truqap is approved in the US, EU, Japan and several other countries to treat adult patients with HR-positive or ER-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations, following recurrence or progression on or after an endocrine-based regimen based on the results from the CAPItello-291 trial.

Truqap is also approved in Australia for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer.

The drug is currently being evaluated in Phase III trials for the treatment of breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281) in combination with established treatments.

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