WILMINGTON, DE — AstraZeneca’s TRUQAP (capivasertib) has won U.S. approval for a subset of patients with advanced prostate cancer, providing the first biomarker-targeted treatment option for an aggressive form of the disease linked to PTEN deficiency.
The U.S. Food and Drug Administration approved TRUQAP in combination with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive prostate cancer, a disease state previously known as metastatic hormone-sensitive prostate cancer.
The approval expands TRUQAP into a second tumor type and reinforces the growing role of biomarker testing in prostate cancer treatment.
The decision was based on results from AstraZeneca’s Phase III CAPItello-281 trial, which 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 was 33.2 months for patients receiving the TRUQAP regimen, compared with 25.7 months for patients in the control arm, representing an improvement of 7.5 months.
Approximately one-quarter of patients diagnosed with metastatic androgen pathway modulation-naïve or sensitive prostate cancer have PTEN-deficient tumors, according to AstraZeneca. The genetic alteration is associated with faster disease progression and poorer outcomes.
“Patients with PTEN-deficient metastatic hormone-sensitive prostate cancer … experience faster progression and worse prognosis than those without PTEN deficiency,” said Dr. Daniel George, director of genitourinary oncology at Duke Cancer Institute and an investigator in the CAPItello-281 trial. “Today’s landmark approval of the capivasertib combination as the first and only targeted treatment option for these patients represents a significant clinical advance.”
The FDA simultaneously approved a companion diagnostic test designed to identify PTEN deficiency in prostate adenocarcinoma tumors, allowing physicians to determine which patients may benefit from the treatment.
AstraZeneca said approximately 35,000 patients in the United States are diagnosed with metastatic androgen pathway modulation-naïve or sensitive prostate cancer each year. Roughly one in four of those patients are estimated to have PTEN-deficient disease.
Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Haematology Business Unit, said the approval highlights the importance of testing for actionable biomarkers in prostate cancer.
While overall survival data from CAPItello-281 remain immature, early results numerically favored the TRUQAP combination. The study will continue to evaluate overall survival as a key secondary endpoint.
The safety profile was generally consistent with previous studies of the medicines involved. Grade 3 or higher adverse events occurred in 67% of patients receiving the TRUQAP combination, with rash and hyperglycemia reported most frequently.
TRUQAP is already approved in certain breast cancer settings. AstraZeneca said a regulatory application seeking approval for the prostate cancer indication remains under review in the European Union.
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