Through the lymph nodes it goes — re­searchers de­vel­op a can­cer drug that avoids tox­i­c­i­ties by skirt­ing the liv­er

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.

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