Date: 2013-01-07
Type of information: Clinical research agreement
Compound: ponatinib (Iclusig®)
Company: Ariad Pharmaceuticals (USA - MA) Newcastle University (UK)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: Ponatinib is a multitargeted oral tyrosine kinase inhibitor. Its primary target is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia -chromosome positive acute lymphoblastic leukemia (Ph+ ALL). It was designed using ARIAD\'s computational and structure-based drug design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which is the most common mutation among resistant patients.
Disease: chronic myeloid leukemia
Details: ARIAD Pharmaceuticals and Newcastle University, on behalf of the U.K. National Cancer Research Institute (NCRI) CML Working Group, have announced an agreement to collaborate on a multicenter, randomized Phase 3 trial, named SPIRIT 3, to assess the impact of switching patients with chronic myeloid leukemia (CML) being treated with a first-line tyrosine kinase inhibitor, upon suboptimal response or treatment failure, to ponatinib. The NCRI expects to begin enrollment in the trial of 1,000 patients at approximately 172 clinical research sites in the U.K. in the second quarter of 2013.
The SPIRIT 3 trial is a randomized, two-arm, multicenter trial that compares major molecular response (MMR) at three years in newly diagnosed patients treated with imatinib to those treated with nilotinib, when patients are \"rescued\" with ponatinib upon suboptimal response at three or 12 months or treatment failure. It will enroll adult patients with chronic-phase CML diagnosed within three months and previously untreated for CML with any TKI therapy. Approximately 1,000 patients will be randomized 1:1 to standard doses of imatinib (400 mg orally once daily) or nilotinib (300 mg orally twice daily). Patients will be switched to ponatinib (45 mg orally once daily) based on defined criteria of suboptimal response, treatment failure, or intolerance to first-line therapy.
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