In a Phase III trial in breast cancer patients, AstraZeneca’s Truqap plus Faslodex reduced disease progression and mortality risk. Credit: Roland Magnusson / Shutterstock.com.
This trial assessed the efficacy of Truqap plus Faslodex compared to placebo plus Faslodex.
Progression-free survival in the overall trial population and subjects with PI3K/AKT pathway alterations were the trial’s dual primary endpoints.
Results from the trial showed that Truqap plus Faslodex halved disease progression and mortality risk.
The safety profile of the combination regimen was consistent with previous studies.
Truqap’s discovery by AstraZeneca followed a partnership with Astex Therapeutics, which now stands to receive milestone payments and royalties from product sales in Japan.
Regulatory reviews are ongoing in regions, including China and the European Union, with the combination already approved in the US and other countries.
AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “Breast cancer is the most common cancer among women in Japan, and innovative new treatment options are urgently needed.
“The approval of Truqap, a first-in-class AKT-inhibitor, represents a significant step forward for HR-positive breast cancer treatment and an important new option for approximately 50% of patients who have tumours with these specific mutations or alterations.”