Lei Lei Wu, News Reporter, Endpoints News

August 18, 2022


PI3K is a protein that is part of a pathway that regulates cell growth, survival and metabolism — earning it the inscription of master regulator for cancer. However, while a number of PI3K inhibitor drugs have been approved since 2014, the class as a whole has dwindled, as it has been plagued by toxicity issues in various blood cancers.

For example, the FDA hit Secura Bio’s PI3K inhibitor Copiktra, which earned accelerated approval in 2018, with an increased death warning in June following the results of its confirmatory Phase III trial. That warning came after a number of companies, including Secura, Gilead and Incyte, withdrew their accelerated approvals for their PI3K inhibitors after failing to complete confirmatory trials. The FDA now requires randomized trials to be conducted for PI3K inhibitors in blood cancers.

But what if a PI3K inhibitor somehow avoided those toxicities? In a paper published in Nature Communications Wednesday, researchers from the University of Michigan describe a dual PI3K and MAPK inhibitor that limited toxicities and extended survival time in mice through what lead investigator Brian Ross called an “unanticipated” mechanism — going through the lymph nodes.


Read the full article at Endpoints News.