ICLUSIG® (ponatinib) Results in CML Treatment

OPTIC trial: An optimized dosing study with ICLUSIG in chronic phase CML

A study evaluating the long-term efficacy, safety, and dosing of ICLUSIG

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OPTIC is a study of adult patients with chronic phase CML who:

Have taken at least 2 prior TKI medicines OR have a mutation known as the T315I mutation

In this study, 94 patients started on 45 mg orally once daily of ICLUSIG and were reduced to 15 mg orally once daily upon achieving a response, regardless of how long they remained on the higher dose.*

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ICLUSIG was shown to help keep BCR::ABL1 levels low in patients:
  • Whose previous medicines no longer worked
  • Who had to switch from a previous medicine because of serious side effects
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ICLUSIG Study Results:
  • 44% of patients (41 of 93 patients) achieved BCR::ABL1 less than or equal to 1% at 12 months†
  • Over 5 years, 60% (56 of 93 patients) of the patients achieved BCR::ABL1 less than or equal to 1% compared to 52% (48 of 93 patients) at 1 year
  • Of the 56 patients who achieved a response over 5 years, 45 patients had a dose reduction to 15 mg after achieving BCR::ABL1 less than or equal to 1%
    • 56% of patients (25 of 45 patients) maintained their response at the reduced dose for at least 1 year
      • Of these 25 patients, 16 patients (64%) maintained response for greater than 60 months
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Efficacy with ICLUSIG in Patients Carrying the T315I Mutation:
  • 44% (11 of 25 patients) of patients with the T315I mutation achieved BCR::ABL1 levels of 1% or less at 12 months
  • 64% of patients with the T315I mutation achieved BCR::ABL1 levels of 1% or less by 60 months
  • Learn more about the T315I mutation here
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Long-lasting and Deep Disease Control with ICLUSIG
  • Over 5 years on ICLUSIG:
    • 46% of patients achieved  BCR::ABL1 levels of 0.1% (1 out of every 1000 cells have the BCR::ABL1 gene) or less
    • 24% of patients achieved  BCR::ABL1 levels of 0.01% (1 out of every 10,000 cells have the BCR::ABL1 gene) or less
    • 13% of patients achieved BCR::ABL1 levels of 0.0032% (1 out of every 32,000 cells have the BCR::ABL1 gene) or less

Every patient is different. Results may vary.

*Response is defined as a reduction in BCR::ABL1 (a specific cancer marker) to less than or equal to 1%. Also known as a 2-log reduction.
†You may hear your doctor refer to this as a 2-log reduction.

PACE trial: A 5-year study of ICLUSIG in the treatment of CML in resistant/intolerant patients

Based on 5-year data from PACE, ICLUSIG was shown to help control CML in adult patients whose disease was considered resistant or intolerant to prior TKI therapy, or who had the T315I mutation.

This study included patients with:

  • Chronic phase CML (CP‑CML)
  • Accelerated phase CML (AP‑CML)
  • Blast phase CML (BP‑CML)
  • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)

All patients started on 45 mg once daily of ICLUSIG.

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Not an actual patient

By 12 months, patients with CP-CML achieved the following results:

55% of patients achieved MAJOR CYTOGENETIC RESPONSE (MCyR):
In 148 out of 267 patients, 0% to 35% of tested cells had the Ph chromosome.

46% of patients achieved COMPLETE CYTOGENETIC RESPONSE (CCyR):
In 123 out of 267 patients, none of the tested cells had the Ph chromosome.

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At 5 years, ICLUSIG was still helping patients who saw results in the first year of CML treatment
  • Of 148 patients with CP-CML who achieved MCyR by 12 months, an estimated 82% would continue to achieve this result at 5 years.
  • Many of these patients maintained MCyR even when their dose of ICLUSIG was reduced.

Every patient is different. Results may vary.

Doctor discussion guide

Prepare for your next visit with your healthcare provider

QUESTIONS TO ASK

How to take ICLUSIG

Learn about once daily oral dosing with ICLUSIG.

GET DOSING INFORMATION

IMPORTANT SAFETY INFORMATION, INDICATIONS, AND USAGE

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