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Takeda to present positive primary analysis from phase 2 OPTIC trial of Iclusig to treat chronic-phase chronic myeloid leukemia at ASCO meeting

wtadmin July 28, 2021 0 Comments

Takeda Pharmaceutical Company announced that primary analysis data from the phase 2 OPTIC (optimizing ponatinib treatment in CML) trial will be presented during an oral session at the virtual 57th American Society of Clinical Oncology (ASCO) Annual Meeting, and as an oral session at the virtual 26th European Hematology Association (EHA) Annual Meeting.
The OPTIC trial is a randomized, open-label study prospectively evaluating response-based dosing regimens of Iclusig (ponatinib) over a range of three starting doses (45-, 30-, or 15-mg) with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML) who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy.

The OPTIC trial, which evaluated treatment in patients with resistant disease, with and without mutations, met its primary endpoint. The study demonstrates that the optimal benefit-risk profile for Iclusig in patients with CP-CML is achieved with a daily starting dose of 45-mg and, upon achieving =1% BCR-ABL1IS, dose reduction to 15-mg. The results also suggest a clinically manageable safety and arterial occlusive event (AOE) profile for Iclusig.

“The primary analysis of the OPTIC data reinforce that Iclusig is very valuable in the management of patients with resistant and intolerant chronic-phase CML. Iclusig should be considered following failure of two or more TKIs. This approach minimizes the need to use back-to-back second-generation TKIs, which is usually associated with low probability of response and poor outcomes,” said Jorge Cortes, MD, Georgia Cancer Center at Augusta University, and an OPTIC trial principal investigator. “These findings further demonstrate that the optimal Iclusig benefit-risk profile can be achieved with a response-based dosing regimen, providing efficacy while reducing risk for arterial occlusive events.”

“There is a misconception that chronic-phase CML is a ‘good cancer’ due to the fact it can be well controlled, but for patients with resistant and intolerant disease, continued investigation and treatment options are critical. The primary analysis of OPTIC solidifies our understanding of how ICLUSIG can address gaps in care for these patients,” said Christopher Arendt, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. “The OPTIC data, along with the recently updated US FDA indication, demonstrate the benefit Iclusig can offer as a third-generation TKI.”

OPTIC (optimizing ponatinib treatment in CML) is an ongoing randomized, dose-ranging trial designed to evaluate three starting doses of Iclusig (45-, 30-, and 15-mg) in patients with resistant chronic-phase chronic myeloid leukemia (CP-CML) or who had documented history of presence of T315I mutation after receiving any number of prior TKIs. Dose reduction at response occurred per study protocol. The trial is expected to inform the optimal use of Iclusig (ponatinib) in these patients. 282 patients were enrolled at clinical sites around the world, with 94 patients receiving the 45-mg starting dose. The primary endpoint of the trial is achieving =1% BCR-ABL1IS at 12 months.

CML – a rare malignancy – is one of four main types of leukemia; it is a result of a genetic mutation that takes place in early, immature versions of myeloid cells, which form red blood cells, platelets and most types of white blood cells. Subsequently, an abnormal gene called BCR-ABL1 forms, turning the damaged cell into a CML cell. CML typically progresses slowly, but it can change into a fast-growing acute leukemia that is hard to treat.

Iclusig is a kinase inhibitor targeting BCR-ABL1, an abnormal tyrosine kinase that is expressed in CML and Ph+ ALL. Iclusig is a targeted cancer medicine developed using a computational and structure-based drug-design platform, specifically designed to inhibit the activity of BCR-ABL1 and its mutations.


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