UK-based pharmaceutical company AstraZeneca has reported positive results from its Phase III CAPItello-281 trial, which evaluated Truqap combined with abiraterone and androgen deprivation therapy (ADT) for prostate cancer.
Truqap showed improvement in radiographic progression-free survival (rPFS) in the trial, which enrolled 1,012 subjects with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).
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The drug’s safety and efficacy were evaluated in combination with abiraterone and ADT against abiraterone and ADT alongside placebo.
The Truqap combination showed a promising early trend towards improved overall survival (OS) compared to the control group receiving abiraterone, ADT and placebo.
Although the OS data are not yet mature, the trial will continue to evaluate this as a secondary endpoint.
Patients in the trial were confirmed to have PTEN deficiency by central testing. The primary endpoint is rPFS, as assessed by the investigator.
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By GlobalDataAstraZeneca oncology R&D executive vice-president Susan Galbraith said: “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.
“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.
“It will be important to see greater maturity in key secondary endpoints including overall survival.”
Truqap has been approved in the European Union, Japan, the US and several other markets for treating certain types of breast cancer.
These approvals were based on the outcomes from the CAPItello-291 study, while the drug is also approved in Australia for similar indications.
AstraZeneca developed the drug in partnership with Astex Therapeutics, the Institute of Cancer Research, and Cancer Research Technology.
The Global Coalition for Adaptive Research (GCAR) recently signed an agreement to evaluate AstraZeneca‘s AZD1390 in the GBM AGILE trial.
