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Cardiff-led FAKTION trial drug truqap receives FDA approval

Professor Rob Jones

Professor Rob Jones, along with Early Phase Clinical Trial Nurses and Clinical Fellow Dr. Magda Meissner, who were previously supported by the WCRC, have played a pivotal role in an Experimental Cancer Medicine Centre (ECMC) trial culminating in the Federal Drug Agency (FDA) approval of the new drug ‘truqap’ as a first in class drug and first licenced clinical indication.

The FAKTION trial was born over 10 years ago from the desire to find ways to improve outcomes in the world’s most common type of cancer – oestrogen receptor positive breast cancer. For patients who are diagnosed with incurable cancer, hormone treatment can help, but often patients become resistant to it.

One particular protein, AKT, is known to drive this resistance. The FAKTION trial investigated whether hormone therapy could be safely combined with AstraZeneca’s AKT inhibitor capivasertib, to improve patient outcomes.

The results from the Phase II FAKTION trial showed that patients who received the combination treatment could expect to have their cancer controlled for twice as long as those receiving hormone therapy alone. A total of 140 patients from 19 hospitals took part in the trial, which was led by Velindre University NHS Trust in Cardiff, and the Christie Hospital in Manchester, along with Cardiff university. The results have been presented at the world’s biggest cancer conference in Chicago and have been published in the Lancet Oncology journal.

The ECMC study’s co-lead, Prof. Rob Jones, of Velindre Cancer Centre and Cardiff University, said: “There has never been a trial targeting this genetic pathway in breast cancer that has an overall survival advantage like this – it’s really quite extraordinary.  This achievement not only signifies a ground-breaking milestone in cancer treatment but also places Wales firmly on the global map for medical innovation.”

The larger AstraZeneca supported Phase III global trial Capitello-291 confirmed these findings and in combination with data from the FAKTION trial formed the crucial part of the FDA application. 

The application received a positive outcome with the USA’s FDA recently announcing it will license the use of capivasertib, now called truqap, in combination with the hormone therapy drug faslodex for use in patients with ER positive, HER2 negative advanced breast cancer. There are still Europe and UK approvals needed before the drug can be used here but the future looks very encouraging for patients with incurable breast cancer.