Capivasertib Gains Support from the FDA’s Advisory Committee in Metastatic Hormone-Sensitive Prostate Cancer
Clinical Summary:
- The FDA’s Oncologic Drugs Advisory Committee has voted that capivasertib plus abiraterone and ADT demonstrates a favorable benefit-risk profile in patients with PTEN-deficient metastatic hormone-sensitive prostate cancer.
- This recommendation was based on results from the phase 3 CAPItello-281 which demonstrated that the triplet regimen improved survival compared to control.
- If approved, capivasertib would become the first targeted treatment option for this high-risk, biomarker-defined prostate cancer subgroup.
On April 30th, 2026, the FDA’s Oncologic Drugs Advisory Committee voted 7 to 1, with 1 abstention, that capivasertib (TRUQAP; AstraZeneca) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrates a favorable benefit-risk profile among patients with PTEN-deficient metastatic hormone-sensitive prostate cancer.
This recommendation was based on results from the phase 3 CAPItello-281 trial and will inform the FDA’s ongoing review of the supplemental New Drug Application.
“Patients identified to have PTEN-deficient metastatic hormone-sensitive prostate cancer have an aggressive form of the disease and currently experience poor outcomes,” stated Daniel George, MD, Duke Cancer Institute, Durham, North Carolina. “Their disease significantly impacts their quality of life and inevitably progresses to more advanced stages that are associated with high mortality rates.”
In this double-blind, placebo-controlled trial, 1012 patients were randomized to receive either capivasertib or placebo plus abiraterone and ADT. The primary end point was radiographic progression-free survival (rPFS). Key secondary end points included time to castration resistance, prostate-specific antigen (PSA) progression, symptomatic skeletal event-free survival (EFS), overall survival (OS), and safety.
At the primary analysis, median rPFS was 33.2 months in the capivasertib arm and 25.7 months in the placebo arm (hazard ratio [HR], 0.81; 95% confidence interval [CI], 0.66-0.98; P = .034), corresponding to a 19% reduction in the risk of radiographic progression or death. Median time to castration resistance was 29.5 months and 22 months, respectively, and PSA progression was delayed. Median symptomatic skeletal EFS was 42.5 months in the capivasertib arm and 37.3 months in the placebo arm. OS data were immature at the time of analysis, although interim results numerically favored the capivasertib combination.
Safety was consistent with prior findings. Grade ≥3 adverse events were reported in 67% of patients in the capivasertib arm and 40.4% of patients in the placebo arm. The most common grade ≥3 adverse events reported in the capivasertib arm included rash (12.3%), hyperglycemia (10.3%), hypokalemia (8.7%), diarrhea (6.2%), hypertension (5.8%), and anemia (5.2%).
“Patients currently have limited treatment options, which is why today’s recommendation of the capivasertib combination is welcome news for both patients and clinicians to address an urgent need for new treatments that delay progression,” concluded Dr George.
Source:
AstraZeneca. TRUQAP® (capivasertib) recommended by FDA advisory committee for PTEN-deficient metastatic hormone-sensitive prostate cancer. Accessed on May 4, 2026. https://www.astrazeneca-us.com/media/press-releases/2026/TRUQAP-capivasertib-recommended-by-FDA-Advisory-Committee-for-PTEN-deficient-metastatic-hormone-sensitive-prostate-cancer.html#!
