Truqap Combination Shines in Phase III Trial for Prostate Cancer
Data from the CAPItello-281 trial show Truqap alongside abiraterone and androgen deprivation therapy achieved a statistically significant and clinically meaningful improvement in radiographic progression-free survival.
AstraZeneca has shared positive, high-level results from the Phase III CAPItello-281 clinical trial evaluating Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT). The combination achieved the study’s primary endpoint by showing a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).1
In a press release, Karim Fizazi, MD, PhD, Institut Gustave Roussy, and University of Paris Saclay in Villejuif, France, and principal investigator for the trial said, “Patients with this aggressive form of prostate cancer with tumor PTEN deficiency currently face a particularly poor prognosis, and there is an urgent need for new treatments that improve upon current therapies. The results seen with capivasertib in combination with abiraterone-prednisone and androgen deprivation therapy in the CAPItello-281 trial represent a step forward for these patients.”
CAPItello-281 is a double-blind, randomized study that enrolled 1,012 adult patients with histologically confirmed mHSPC. Alongside the primary endpoint of rPFS, overall survival (OS) is the secondary endpoint.
According to AstraZeneca, OS data were immature at the time of this most recent analysis. However, the Truqap-abiraterone and ADT duo showed early signs of an improvement in OS versus abiraterone and ADT with placebo. The trial will be continuing to further assess OS as a key secondary endpoint.
"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,” Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, said in the press release.
Earlier in June, AstraZeneca announced that Truqap in cominbation with Faslodex (fulvestrant) was approved in the EU for the treatment of adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.2
The approval was based on results from the Phase III, double-blind, randomized CAPItello-291 trial. The Truqap-Faslodex combination reduced the risk of disease progression or death by 50% versus Faslodex alone in a biomarker-altered population.
In an earlier press release, Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “Truqap is now the first and only AKT inhibitor approved in the European Union for patients with ER-positive breast cancer who have tumors harboring these specific biomarkers. Breast cancer continues to be the leading cause of cancer-related death in Europe, and today’s news represents a significant step forward in providing an important new treatment option for patients in need of new, innovative therapies.”
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. News release. AstraZeneca. November 25, 2024. Accessed November 26, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/truqap-improved-rpfs-in-advanced-prostate-cancer.html
2. Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer. News release. AstraZeneca. June 20, 2024. Accessed November 26, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/truqap-plus-faslodex-approved-in-the-eu-for-patients-with-advanced-er-positive-breast-cancer.html
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