Truqap Combination Shows Breakthrough Results In PTEN-Deficient Prostate Cancer, Boosting Survival Rates

AstraZeneca's CAPItello-281 Phase III trial revealed promising results, with Truqap (capivasertib) combined with abiraterone and androgen deprivation therapy (ADT) showing a statistically significant and clinically relevant improvement in radiographic progression-free survival (rPFS) compared to abiraterone and ADT with a placebo. This finding is particularly notable for patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).

Although overall survival (OS) data were not yet mature at the time of this analysis, early indications suggest a potential OS benefit for the Truqap combination over abiraterone and ADT with placebo. The trial will proceed as planned, with OS being closely monitored as a key secondary endpoint.

Prostate cancer ranks as the second most common cancer in men and is the fifth leading cause of cancer-related deaths in males worldwide. Just one-third of individuals diagnosed with metastatic prostate cancer survive for five years following their diagnosis. 

Newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) is an aggressive variant of the disease, often linked to unfavorable outcomes and lower survival rates. Around 200,000 men are diagnosed with mHSPC annually, with approximately one-quarter of them having PTEN-deficient tumors. This specific biomarker indicates a particularly poor prognosis for affected patients.

Karim Fizazi, MD, PhD, Institut Gustave Roussy, and University of Paris Saclay in Villejuif, France, and principal investigator for the trial, said in a statement, “Patients with this aggressive form of prostate cancer with tumour 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.”

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, also commented, “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.”

The safety profile of Truqap, when used alongside abiraterone and ADT in the CAPItello-281 trial, was generally in line with the established safety profiles of each individual medication. Detailed data from the trial will be presented at an upcoming medical conference and submitted to global regulatory authorities for review.