ICLUSIG® (ponatinib) has been studied in patients in 3L or later over 48 months.

A look at the PACE trial

In this single-arm, open-label, international, multicenter trial, all patients were administered a starting dose of 45 mg of ICLUSIG once daily. The primary efficacy endpoint in CP-CML (n=267) was major cytogenetic response (MCyR) by 12 months. The primary endpoint for AP-CML (n=83), BP-CML (n=62), and Ph+ ALL (n=32) was major hematologic response (MaHR) by 6 months. Minimum of 48 months of follow-up for all ongoing patients (n=133). The trial enrolled 449 patients of which 444 were eligible for efficacy analysis.

PACE Trial Patient Characteristics

93%

OF PATIENTS HAD PROGRESSED TO THIRD LINE (3L) OR LATER (n = 415)


88%

OF PATIENTS WERE RESISTANT TO PRIOR TKI THERAPY (n = 374)


55%

OF PATIENTS HAD 1 OR MORE BCR-ABL KINASE DOMAIN MUTATIONS AT BASELINE * (n = 244)

*Of the patients with 1 or more BCR-ABL kinase domain mutations detected at entry, 37 unique mutations were detected.