The drug, a small molecule protein inhibitor, brought in $132 million in the first quarter, missing consensus estimates by 17%.
AstraZeneca is discontinuing the late-stage CAPItello-280 trial, which was evaluating its AKT blocker Truqap in patients with metastatic castration-resistant prostate cancer, the pharma announced on Tuesday.
The study, which combined Truqap with docetaxel and androgen-deprivation therapy (ADT), is unlikely to meet its dual primary endpoints of overall survival and radiographic progression-free survival (rPFS), as per an interim analysis by an independent data monitoring committee.
AstraZeneca did not provide specific data in its news release on Tuesday, revealing only that it will work with investigators to make sure that patients undergo “necessary follow-up.”
Despite this failure, the pharma remains confident in Truqap’s market opportunity, with CEO Pascal Soirot telling reporters in a media call Tuesday that AstraZeneca still expects the drug to bring in between $1 billion and $3 billion per year, according to Fierce Pharma.
In the first quarter, Truqap brought in $132 million in sales, driven by its dominant market presence in the second-line setting for patients with breast cancer who have altered biomarkers, according to the pharma’s Q1 earnings report. This fell 17% below consensus estimates, however, as per a Leerink analyst note on Tuesday.
“Impressively, at one year post-launch, Truqap has achieved nearly 100% market share in the AKT/PTEN biomarker-altered population, with additional opportunity for growth in the PIK3CA population,” Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Business, said during the company’s investor call.
Designed to be taken orally, Truqap is a small-molecule inhibitor of all three isoforms of the AKT protein, which in cancers is often mutated and activated, leading to the abnormal cell growth and survival that are hallmarks of malignancies. Truqap’s mechanism of action allows it to disrupt this pathway and block tumor growth.
So far, Truqap has one approval under its belt, granted in November 2023 when the FDA cleared it for use in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer, whose tumors harbor mutations to the PIK3CA/AKT1/PTEN pathway.
AstraZeneca has since been trying to push Truqap into new indications, though its results have been mixed so far. In November last year, the pharma announced that the drug hit its key outcomes in the Phase III CAPItello-281 study, significantly improving rPFS when used with ADT and abiraterone in a specific subset of patients with prostate cancer—those who had PTEN-deficient de novo metastatic hormone-sensitive disease.
However, a few months earlier, in June 2024, Truqap failed the late-stage CAPItello-290 trial in metastatic triple-negative breast cancer. The drug could not significantly improve overall survival in patients with this condition.
