Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) recently shared long-term follow-up data from the Phase II PACE clinical study of ponatinib (Iclusig). The data are from the trial of the drug in patients with chronic myeloid leukemia (CML) who had received prior treatment but whose condition proved to be resistant or intolerant to other drugs.
According to Ariad Pharmaceuticals, patients who received ponatinib treatment demonstrated anti-leukemic activity for a median duration of 4 years. The company further said that 96% of the patients who received reduced doses of ponatinib maintained a positive response to the treatment at the four-year follow-up.
The data obtained from ponatinib treatment over the four-year follow-up period in previously heavily treated patients have generated quite a bit of excitement. According to Jorge E. Cortes of University of Texas MD Anderson Cancer Center’s department of leukemia, the data provide a glimpse of the future where patients who previously never had a treatment options may find relief.
ARIA’s long-term follow-up data on ponatinib was featured at the 21st European Hematology Association (EHA) conference held in Copenhagen, Denmark.
Details of the study
The study was designed to assess the efficacy and safety of ponatinib. Enrollment was completed in October 2011 and a total of 449 patients were enrolled. The patients received a starting dose of ponatinib of 45mg per day.
In the updated data, 270 patients remained in the study at the median follow-up period of 48.2 months. Of those patients, 41% of them continued to receive ponatinib treatment. The overall survival with ponatinib treatment is estimated at 77%.
Ariad Pharmaceuticals said that there are currently two other ponatinib studies underway. One of the studies involves a randomized trial that is designed to evaluate the drug at doses of 45mg per day or lower. Ariad is still recruiting patients for that study.
The other study is a randomized Phase 3 trial that is being done outside the U.S. and full enrollment for the second trial is expected to be complete in 2018.