AstraZeneca has reported positive results from the CAPItello-281 phase 3 trial, which evaluated Truqap (capivasertib) in combination with Johnson & Johnson’s Zytiga (abiraterone) and androgen deprivation therapy (ADT) in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC). The combination therapy showed significant improvements on its primary endpoint of radiographic progression-free survival (rPFS) of patients with this form of prostate cancer as compared to treatment with Zytiga and ADT alone.
“Patients with this aggressive form of prostate cancer (...) currently face a particularly poor prognosis, and there is an urgent need for new treatments that improve upon current therapies,” said Karim Fizazi, professor of oncology at the University of Paris-Saclay and principal investigator of the trial. “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.”
While the full data analysis will be released later on, high-level results show a promising trend in the overall survival of patients treated with the combination therapy. The CAPItello-281 trial, which has over 1,000 adult patients enrolled, is expected to continue as planned to assess overall survival as a secondary endpoint.
Truqab is a first-in-class inhibitor that targets all three isoforms of the AKT molecule, which plays a key role in the ability of many cancer cells to survive, grow and resist treatment. The treatment is already approved in the US, EU, Japan and other countries for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN).
The results of the CAPItello-281 phase 3 trial make AstraZeneca’s combination therapy the first and only AKT inhibitor combination to have demonstrated benefit in patients with this specific form of prostate cancer.
“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,” said Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca. “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.”