Will the clinical development of 4th-generation “double mutant active” ALK TKIs (TPX-0131 and NVL-655) change the future treatment paradigm of ALK+ NSCLC?

Abstract

Highlights • Concise yet comprehensive review of randomized phase 3 trials of ALK TKIs and approval timeline in the US.• TPX-0131 and NVL-655 are 4th generation “double mutant active” ALK TKI as opposed to current 2nd and 3rd generation “single mutant active” ALK TKIs.• Three randomized phase 3 designs are porposed for the development of these 4th generation ALK TKIs.