AstraZeneca has discontinued a Phase III trial of Truqap (capivasertib) after a review concluded that the study was unlikely to meet its endpoints.
The CAPItello-280 study (NCT05348577) was investigating Truqap in combination with docetaxel and androgen-deprivation therapy (ADT) compared to docetaxel and ADT with placebo in patients with metastatic castration-resistant prostate cancer (mCRPC).
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The pharma giant decided to scrap the study after an Independent Data Monitoring Committee (IDMC) said it was unlikely that the combination would meet the dual primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) versus the comparator arm.
AstraZeneca said the safety and tolerability profile for Truqap was consistent with other trials.
This is another blow for one of AstraZeneca’s flagship oncology products, which failed to meet the primary endpoint of overall survival (OS) in either patient group in the Phase III CAPItello-290 trial (NCT03997123) in June 2024. The CAPItello-290 study was investigating the drug in combination with paclitaxel in patients with locally advanced (inoperable) or metastatic triple-negative breast cancer (TNBC).
In November 2024, however, the drug did prove efficacious in the Phase III CAPItello-281 trial, meeting the primary endpoint of radiographic progression-free survival in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer.
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By GlobalDataTruqap is an adenosine triphosphate (ATP)-competitive inhibitor that targets all three AKT isoforms (AKT1/2/3). It was approved by the US Food and Drug Administration (FDA) in November 2023 for use in combination with Faslodex for the treatment of advanced HR-positive breast cancer.
The drug was given priority review and assessed through Project Orbis, a programme that facilitates the simultaneous submission and evaluation of oncology medications by collaborating with international partners. The drug has since been approved for use in Europe and the UK, with access available through the NHS.
GlobalData forecasts that Truqap will reach blockbuster status in 2027, with global sales in 2030 set to hit $1.78bn.
GlobalData is the parent company of Clinical Trials Arena.
