AstraZeneca's (LSE:AZN) Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy has been approved in the US for adult patients with PTEN‑deficient mAPMN/S prostate cancer, based on an FDA‑authorised companion diagnostic.
The approval was driven by the Phase III CAPItello‑281 primary analysis, which showed a statistically significant 19% reduction in the risk of radiographic disease progression or death (HR 0.81; 95% CI 0.66-0.98; p=0.034) and a median rPFS gain of 7.5 months (33.2 vs 25.7 months).
The safety profile was consistent with known effects of the medicines, with grade 3 or higher adverse events in 67% of patients and the most frequent being rash (12.3%) and hyperglycaemia (10.3%), while overall survival data were immature but numerically favoured the Truqap arm.
"Today's landmark approval of the capivasertib combination as the first and only targeted treatment option for these patients represents a significant clinical advance with the potential to improve their lives and change the course of disease," said Daniel George, MD, Director of Genitourinary Oncology at Duke Cancer Institute and investigator for CAPItello‑281.
mAPMN/S prostate cancer affects roughly 200,000 patients globally each year, with about 35,000 in the US, and roughly one in four of those patients have PTEN‑deficient tumours that are associated with poor prognosis and identifiable by immunohistochemistry.
Truqap is a first‑in‑class AKT inhibitor already approved in breast cancer combinations and is given at 400mg twice daily on an intermittent four‑days‑on, three‑days‑off schedule.
The FDA also cleared a companion diagnostic for PTEN deficiency and AstraZeneca has a regulatory application under review in the EU while CAPItello‑281 will continue to follow overall survival as a key secondary endpoint.
