As soon as you see resistance to a 2nd TKI, consider ICLUSIG first—the only 3G BCR::ABL1 inhibitor with 5-year data in TKI-resistant CP-CML1,2  


ICLUSIG clinical trials were designed to evaluate efficacy and safety in adults with TKI-resistant CP-CML, regardless of mutation1-4

PACE 5-year results from the pivotal study that included TKI-resistant patients with CP-CML (n=270). OPTIC Dose-optimization study in patients with TKI-resistant CP-CML (N=282).

The most common (>20%) adverse reactions are rash and related conditions, arthralgia, abdominal pain, headache, constipation, dry skin, hypertension, fatigue, fluid retention and edema, pyrexia, nausea, pancreatitis/lipase elevation, hemorrhage, anemia, hepatic dysfunction, and AOEs. The most common Grade 3 or 4 laboratory abnormalities (>20%) are platelet count decreased, neutrophil cell count decreased, and white blood cell decreased.1

Discover clinical data highlights from the PACE and OPTIC trials

PACE and OPTIC trials support choosing ICLUSIG for patients with CP-CML: as soon as they become resistant or intolerant to a 2nd TKI, regardless of mutation status, if they have T315I-positive CML & who need proven efficacy with an optimized risk:benefit profile, who prefer convenient, single-tablet, once-daily dosing with or without food.

*The PACE trial was a single-arm, open-label, international, multicenter, phase 2 trial in adult CML or Ph+ ALL patients whose disease was considered to be resistant or intolerant to a prior kinase inhibitor, or who had T315I mutation (N=449; n=270 CP-CML, n=85 AP-CML, n=62 BP-CML, n=32 Ph+ ALL). Sixty-four patients in the CP-CML cohort were T315I positive.1-3
OPTIC is an ongoing, dose-optimization trial evaluating 3 starting doses (45 mg/day, 30 mg/day, and 15 mg/day) of ICLUSIG in 282 adult patients with CP-CML whose disease was considered to be resistant or resistant/intolerant to at least 2 prior TKI therapies or who have the T315I mutation. Patients were randomized 1:1:1 to 3 cohorts, 45 mg/day, 30 mg/day, or 15 mg/day. Dose reductions were applied to the 45 mg/day and 30 mg/day cohorts upon achievement of ≤1% BCR::ABL1IS.1,4