ICLUSIG (ponatinib) delivered clinically meaningful responses in Ph+ ALL1,2

PACE trial studied TKI-resistant or intolerant patients with mutations, including T315I1,2

ICLUSIG monotherapy helped difficult-to-treat patients with Ph+ ALL achieve a response1,2 

PACE TRIAL DESIGN

The PACE trial for ICLUSIG was a single-arm, open-label, international, multicenter, phase 2 trial in adult patients with CML or Ph+ ALL, resistant or intoleranta to 2 TKIs, or who had the T315I mutation regardless of prior TKI use. Primary endpoint for Ph+ ALL was MaHR by 6 months.1,2

In PACE, the starting dose of ICLUSIG (ponatinib) was 45 mg administered orally once daily, given as a single agent. Median duration of follow-up for the Ph+ ALL cohort was 6 months.2 Patients with uncontrolled hypertriglyceridemia and patients with clinically significant or active cardiovascular disease, including any history of clinically significant atrial/ventricular arrhythmias or history of myocardial infarction, unstable angina, or congestive heart failure within the 3 months prior to the first dose of ICLUSIG (ponatinib), were excluded.1,2

a Resistance in Ph+ ALL was defined as failure to achieve either a MaHR (by 1 month in Ph+ ALL), loss of MaHR (at any time), or development of a kinase domain mutation in the absence of a complete MaHR while on prior TKI therapy. Intolerance was defined as the discontinuation of prior TKI therapy due to toxicities despite optimal management in the absence of MaHR for patients with Ph+ ALL.1

PATIENT CHARACTERISTICS

In the PACE clinical trial, the vast majority of study patients (84%) were TKI-resistant and 69% of patients had the T315I mutation.3 

Patient characteristics of participants in the PACE Trial for PH+ALL.

PATIENTS TAKING ICLUSIG REACHED IMPORTANT MARKERS OF RESPONSE1

41 percent (95% CI: 24, 59) achieve MaHR by 6 months (n=32). The primary efficacy endpoint for Ph+ ALL was MaHR by 6 months.
  • Median time to MaHR 0.7 months (range: 0.4-6.0 months)1
  • Median duration of MaHR 3.5 months (range: 1.9-13.7 months)1
  • Median duration of follow-up for the Ph+ ALL cohort was 6 months.4
aThe primary endpoint for Ph+ ALL of MaHR by 6 months combined complete hematologic responses (CHR) and no evidence of leukemia.1
bCHR: WBC ≤institutional ULN; ANC ≥1000/mm3; platelets ≥100,000/mm3; no blasts or promyelocytes in peripheral blood; bone marrow blasts ≤5; <5% myelocytes plus metamyelocytes in peripheral blood; basophils <5% in peripheral blood; and no extramedullary involvement (including no hepatomegaly or splenomegaly).1

Cytogenetic responses at any time4

ICLUSIG DELIVERED CLINICALLY MEANINGFUL RESPONSES4

38 percent of CCyR patients and 47 percent of MCyR patients had a Cytogenetic response at any time.

Review the safety profile in resistant/intolerant Ph+ ALL

PACE safety data in Ph+ ALL

See the convenient dosing schedule for ICLUSIG

Dosing overview

ANC=absolute neutrophil count; CCyR=complete cytogenetic response; CHR=complete hematologic response; AP-CML=accelerated phase chronic myeloid leukemia; MaHR=major hematological response; MCyR=major cytogenetic response; Ph+ ALL=Philadelphia chromosome-positive acute lymphoblastic leukemia; TKI=tyrosine kinase inhibitor; ULN=upper limit of normal for the lab; WBC=white blood cell.

IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE

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