Dr. Cortes on the 192-Week Follow-Up Results of the ENESTop Trial in CML

Jorge E. Cortes, MD, deputy chair and professor of medicine, Department of Leukemia, The University of Texas MD Anderson Cancer Center, discusses The 192-week follow-up results of the ENESTop trial in chronic myeloid leukemia. (CML).

In the trial, patients who failed to achieve a deep molecular response with imatinib (Gleevec) switched to nilotinib (Tasigna). Patients who sustained a deep molecular response on nilotinib for 2 years were allowed to discontinue therapy. At 48 weeks, the rate of treatment-free remission (TFR) was 57.9%. The 144-week follow-up demonstrated that TFR was sustainable. This is an important finding because the majority of relapses are likely to occur in the first 6 months of discontinuing therapy, says Cortes. The 192-week TFR rate was 50.3%, demonstrating the long-term durability and safety of TFR following second-line nilotinib.

A small percentage of patients lost their major molecular response or had a confirmed loss of MR4. These patients restarted therapy with nilotinib and the majority were able to regain their response to therapy. Close monitoring was advised among patients who stopped treatment to catch relapses early, concludes Cortes.