Among patients with PTEN-deficient metastatic hormone-sensitive prostate cancer, Truqap (capivasertib) combined with Zytiga (abiraterone acetate) and androgen deprivation therapy (ADT) demonstrated a statistically and clinically meaningful improvement in radiographic progression-free survival compared with the placebo plus Zytiga.
Patients with a tumor biomarker indicating PTEN deficiency have a particularly unfavorable prognosis, according to a news release from Truqap manufacturer AstraZeneca.
In addition, the safety profile of the Truqap combination with Zytiga and ADT in the phase 3 CAPitello-281 clinical trial was broadly consistent with each treatment’s known safety profile. Although overall survival data were immature at the time of analysis, the Truqap combination showed an early trend towards overall survival improvement compared with abiraterone and ADT with placebo.
“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 [Truqap] in combination with abiraterone-prednisone and androgen deprivation therapy in the CAPItello-281 trial represent a step forward for these patients,” principal investigator Dr. Karim Fizazi of Institut Gustave Roussy and University of Paris Saclay in Villejuif, France said in the news release.
The CAPitello-281 trial is evaluating the efficacy and safety of Truqap in combination with Zytiga and ADT versus Zytiga and ADT combination with a placebo.
A total of 1,012 adult patients were enrolled. The study aims to measure radiographic progression-free survival (rPFS) in patients with asymptomatic or mildly symptomatic, histologically-confirmed de novo hormone-sensitive prostate adenocarcinoma without small-cell tumors and diagnosed within 180 days of randomization.
Susan Galbraith, Executive Vice President, Oncology R&D for AstraZeneca, said in the news release, “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.”
Patients were to receive 400 milligrams (mg) of Truqap via two tablets given on an intermittent weekly dosing schedule. This includes treatment on days one to four in each week of a 28-day treatment cycle until disease progression or unacceptable side effects develop. In addition, patients were to receive 1,000 mg of Zytiga orally as tablets. This treatment was administered continuously until patients met the criteria for discontinuation.
According to ClincialTrials.gov, the trials main focus of the CAPitello-281 trial was rPFS. Furthermore, the trial included secondary endpoints of overall survival defined as the length from randomization until the date of death due to any cause, time to start of first subsequent therapy or death, symptomatic skeletal event-free survival and time to pain progression.
The trial is planned to continue to further assess overall survival as key secondary focus.
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