How ICLUSIG® (ponatinib) May Help

OPTIC trial: A response-based dosing study with ICLUSIG in CP‑CML

A study evaluating the efficacy, safety, and dosing of ICLUSIG

OPTIC is an ongoing 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.*

ICLUSIG was shown to help keep BCR-ABL levels low in patients:
  • Whose previous medicines no longer worked
  • Who had to switch from a previous medicine because of serious side effects
ICLUSIG Study Results 
  • 44% of patients (41 of 93 patients) achieved BCR-ABL less than or equal to 1% at 12 months
  • 62% (28 of 45 patients) continued to see a benefit from ICLUSIG for at least 90 days after their dose was reduced.

Every patient is different. Results may vary.

*Defined as a reduction in BCR-ABL 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

Close up photo of man.

Not an actual patient

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.

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.

At 5 years, ICLUSIG was still helping patients who saw results in the first year of 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

How to take ICLUSIG

Learn about once daily oral dosing with ICLUSIG.