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ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) and Newcastle University, U.K., on behalf of the U.K. National Cancer Research Institute (NCRI) CML Working Group, today 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 study was designed in partnership with ARIAD to provide the scientific community and patients living with chronic-phase CML a deeper understanding of the most effective ways to use TKIs and whether we can improve treatment outcomes by switching patients to ponatinib, who have failed to achieve optimal response from imatinib or nilotinib,” stated Stephen G. O’Brien, Professor of Haematology at the Northern Institute for Cancer Research at Newcastle University, NCRI member and chief investigator of the SPIRIT 3 study. “We look forward to assessing ponatinib as a treatment in this setting and evaluating its potential clinical, economic and quality-of-life benefits.”
Trial Design and Statistical Analysis
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. The SPIRIT 3 trial 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.