ARIAD and the U.K. National Cancer Research Institute to Collaborate on SPIRIT 3
Clinical Study
Evaluation of the Impact of Switching CML Patients Treated with a First-line
Tyrosine Kinase Inhibitor to Ponatinib
CAMBRIDGE, Mass. & LONDON, Jan 07, 2013 (BUSINESS WIRE) -- ARIAD Pharmaceuticals,
Inc. (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.
The primary endpoint of the study is the proportion of patients who have achieved
MMR at three years on their initially allocated first line of therapy, regardless
of switch to ponatinib. MMR is defined as a less than or equal to 0.1% ratio of
BCR-ABL to ABL transcripts on the International Scale measured in peripheral
blood by PCR testing.
