ICLUSIG^® (ponatinib) May Help Patients With Ph+ ALL

ICLUSIG + chemotherapy was studied in adults with newly diagnosed Ph+ ALL

The efficacy and safety of ICLUSIG were studied in adults newly diagnosed with Ph+ ALL. People in the study received ICLUSIG or imatinib, another TKI, in combination with chemotherapy. 154 people received ICLUSIG + chemotherapy and 78 received imatinib + chemotherapy. The study looked at the ability of ICLUSIG + chemotherapy to achieve a deep remission (MRD-negative CR) in the bone marrow at 3 months.

STUDY PARTICIPANTS WERE DIVIDED INTO 2 GROUPS

The first group received ICLUSIG + low-intensity chemotherapy. The second group received imatinib + low-intensity chemotherapy.

ICLUSIG + chemotherapy achieved a deep remission in adults newly diagnosed with Ph+ ALL

PERCENTAGE OF PEOPLE WHO ACHIEVED MRD-NEGATIVE CR AT 3 MONTHS

Over twice as many people who took ICLUSIG + chemotherapy achieved a deep remission vs imatinib after 3 months of treatment.

DEEP REMISSION (MRD-negative CR)

MRD-negative was defined as no to very low BCR-ABL1 detectable in the bone marrow by highly sensitive tests.
CR (complete remission) was defined as very low cancerous cells detectable in the bone marrow and no residual disease outside the bone marrow.

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ICLUSIG was studied in adults with Ph+ ALL whose prior TKIs stopped working

A study looked at the safety and efficacy of ICLUSIG in 32 adult patients whose Ph+ ALL was resistant or intolerant to 2 or more TKIs or that had the T315I mutation.

The study looked at 2 types of treatment responses to see how well ICLUSIG was working:

COMPLETE HEMATOLOGIC RESPONSE (CHR):

This means blood cell counts go down to a normal amount.

MAJOR HEMATOLOGIC RESPONSE (MaHR):

In addition to blood cell counts going down to a normal amount, there is also no evidence of leukemia.

Talk to your doctor about these results to learn more about how ICLUSIG was studied and how it could be a part of your treatment plan.

ICLUSIG was effective in Ph+ ALL when prior TKIs stopped working

34% of patients achieved CHR by 6 months. 41% of patients achieved MaHR by 6 months.

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Side effects with ICLUSIG

Get details about potential side effects from clinical studies.

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