WILMINGTON, DE — An advisory committee to the U.S. Food and Drug Administration voted 7-1, with one abstention, that AstraZeneca’s TRUQAP combination therapy demonstrated a favorable benefit-risk profile for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer, a subtype associated with poor clinical outcomes and limited treatment options.
The recommendation from the FDA’s Oncologic Drugs Advisory Committee was based on results from the Phase III CAPItello-281 trial evaluating TRUQAP (capivasertib) in combination with abiraterone and androgen deprivation therapy.
The FDA accepted AstraZeneca’s supplemental New Drug Application for the combination therapy in August 2025. The agency is not required to follow advisory committee recommendations but typically considers them during its review process.
Results from the CAPItello-281 trial showed the combination reduced the risk of radiographic disease progression or death by 19% compared with abiraterone and androgen deprivation therapy alone.
Median radiographic progression-free survival reached 33.2 months for patients receiving the TRUQAP regimen versus 25.7 months for the comparator arm, according to data presented at the 2025 European Society for Medical Oncology Congress and later published in Annals of Oncology.
The study also showed improvements in secondary endpoints including delayed progression to castration-resistant disease and longer prostate-specific antigen progression timelines.
Overall survival data remained immature at the time of the primary analysis, though interim results numerically favored the TRUQAP combination, AstraZeneca indicated.
“Patients identified to have PTEN-deficient metastatic hormone-sensitive prostate cancer have an aggressive form of the disease and currently experience poor outcomes,” Daniel George, director of genitourinary oncology at Duke Cancer Institute and an investigator for the trial, said in a statement.
Grade 3 or higher adverse events occurred in 67% of patients treated with the TRUQAP combination, compared with 40.4% in the comparator group.
The most common severe adverse events included rash, hyperglycemia, hypokalemia, diarrhea, hypertension, and anemia.
Susan Galbraith, executive vice president of oncology hematology research and development at AstraZeneca, described the CAPItello-281 trial as the first pivotal study to prospectively define PTEN-deficient metastatic hormone-sensitive prostate cancer as a distinct disease subgroup.
A regulatory application for the treatment combination also is under review in the European Union.
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