The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has delivered a strong signal of confidence in its review of a new prostate cancer treatment regimen.

 

This was after finding a favourable benefit–risk profile for Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC).

 

In a decisive 7–1 vote, with one abstention, the Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer.

 

Clinicians involved in the trial underscored the urgency of new options for this high-risk population.

 

Daniel George, Director of Genitourinary Oncology at Duke Cancer Institute and trial investigator, said: “Patients identified to have PTEN-deficient metastatic hormone-sensitive prostate cancer have an aggressive form of the disease and currently experience poor outcomes. 

 

"Their disease significantly impacts their quality of life and inevitably progresses to more advanced stages that are associated with high mortality rates. In addition to this poor prognosis, 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.”

 

AstraZeneca highlighted the significance of the trial in defining this patient subgroup and demonstrating clinical benefit.

 

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “CAPItello-281 is the first pivotal trial to prospectively define PTEN-deficient metastatic hormone-sensitive prostate cancer and its severe course of disease. 

 

"The Committee’s recognition of the unmet need in patients with PTEN-deficiency and of the benefit seen with the Truqap combination verifies its potential to address this significant need and optimise outcomes for patients. We are committed to working closely with the FDA to bring the first and only targeted treatment option to the one in four patients with this form of metastatic hormone-sensitive prostate cancer.”

 

The Phase III results showed a 19% reduction in the risk of radiographic disease progression or death compared with abiraterone plus ADT and placebo, translating into a median radiographic progression-free survival (rPFS) of 33.2 months versus 25.7 months.

 

Overall survival data remain immature, though interim results continue to favour the combination. The trial is ongoing.