AstraZeneca's (LSE:AZN) CAPItello‑281 primary analysis showed a statistically significant 19% reduction in the risk of radiographic progression or death with the Truqap combination versus abiraterone and ADT with placebo (HR 0.81; 95% CI 0.66-0.98; p=0.034), extending median rPFS by 7.5 months to 33.2 versus 25.7 months.
The global trial enrolled 1,012 patients with centrally confirmed de novo PTEN‑deficient mHSPC and the Truqap combination produced consistent benefit across key secondaries, including time to castration resistance (29.5 vs 22.0 months, HR 0.77) and PSA progression (HR 0.73), while overall survival data remain immature but numerically favour Truqap.
The safety profile showed higher toxicity with the addition of Truqap, with Grade 3+ adverse events in 67% of patients versus 40.4% on control, most commonly rash (12.3%), hyperglycaemia (10.3%), hypokalaemia (8.7%), diarrhoea (6.2%), hypertension (5.8%) and anaemia (5.2%).
"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," said Susan Galbraith, Executive Vice President, Oncology Haematology R&D.
The ODAC recommendation follows FDA acceptance of the supplemental NDA in August 2025, the FDA will consider the Committee's advice as it reviews the filing, a parallel EU application is under review, and the trial will continue to assess overall survival as a key secondary endpoint.
