I’m presenting a study on gastrointestinal stromal tumour, which is a rare sarcoma. Most of them are driven by mutations in the KIT receptor tyrosine kinase and we use tyrosine kinase inhibitors to treat them. Sunitinib has been the standard drug for about 20 years for second-line treatment of GIST and in this study we’re comparing sunitinib alone to a combination of sunitinib and a new drug called bezuclastinib. The idea behind it is to more completely inhibit the resistance mutations that might emerge, because different tumours in different people can have different mechanisms of resistance. The combination more fully inhibits the spectrum of mutations that can arise in KIT.

What was the methodology and findings?

It was a randomised study conducted across the globe. It was open label and patients were randomly assigned to either sunitinib alone or to sunitinib with bezuclastinib. The primary endpoint was progression free survival and it showed a significant improvement in progression free survival with the combination with a median of about 16 months with the combination compared to 9 months with sunitinib alone. That corresponded to a hazard ratio of 0.5, which is a highly significant change. It also had a very high response rate of about 48%, compared to about 26% for sunitinib.

What impact could these findings have in the clinic?

The impact is hopefully this will become the new standard for second-line treatment of gastrointestinal stromal tumour. The company announced yesterday in a press release that the FDA had accepted the new drug application and assigned a PDUFA date at the end of November so it’s undergoing regulatory review right now and hopefully it will be approved by the end of the year.