NEW YORK – AstraZeneca on Monday said it will share with global regulatory authorities results from a Phase III trial that demonstrated improved radiographic progression-free survival for patients with PTEN-deficient, de novo metastatic, hormone-sensitive prostate cancer on a regimen including the AKT inhibitor Truqap (capivasertib) compared to standard therapy.
In the CAPItello-281 Phase III trial, AstraZeneca randomized more than 1,000 patients with de novo hormone-sensitive prostate adenocarcinoma with PTEN deficiency to receive Truqap with Janssen's Zytiga (abiraterone) and androgen deprivation therapy (ADT) or placebo with Zytiga and ADT. In addition to the statistically significant and clinically meaningful improvement in radiographic progression-free survival benefit, AstraZeneca said there was a trend toward improvement in overall survival, although the data were immature.
About one in four patients with metastatic hormone-sensitive prostate cancer have PTEN-deficient tumors, and those patients have worse outcomes than patients without PTEN deficiency.
"These results show for the first time that adding an AKT inhibitor to a standard-of-care therapy can provide benefit to patients with a biomarker of PTEN-deficient metastatic, hormone-sensitive prostate cancer," Susan Galbraith, AstraZeneca's executive VP of oncology R&D, said in a statement. "By targeting a key driver of the disease, we have been able to improve upon current therapies and demonstrate the potential role of this combination in an area of critical unmet need."
The US Food and Drug Administration approved Truqap with the selective estrogen receptor degrader fulvestrant as a treatment for patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancers bearing alterations in PIK3CA, AKT1, or PTEN in November 2023. The drug was approved in combination with fulvestrant in the same setting by the European Commission in June.