Dose-escalation of second-line and first-line asciminib in chronic myeloid leukemia in chronic phase: the ASC2ESCALATE Phase II trial

Up to 40% of newly diagnosed pa tien ts with chronic myeloid leukemia in chronic phase (CML-CP) discon tinue trea tmen t by 5 years, pr imar ily due t o resistanc e or int oleranc e. Rat es of resistance to second-line (2L) trea tmen t are also high. Some pa tien ts with resistance respond with dose escalation of tyrosine kinase inhibitors (TKIs). Asciminib demonstrated safety and efficacy across a broad dosage range. ASC2ESCALATE is an ongoing, Phase II, multic ent er, single-arm, dose-escalation study of asciminib in 2L and first-line trea tmen t of CML-CP. The primary end point is major molecular response at 12 months in 2L. Secondary end points include molecular responses at and by scheduled time poin ts, surviv al, and safety. ASC2ESCALATE is the first study investigating asciminib in CML-CP following failure of one prior TKI.