Novartis has reaffirmed the long-term success of Tasigna (Ingredient: Nilotinib) as a treatment free remission agent (TFR) in curing patients with chronic myeloid leukemia.

The two abstracts released at the recent European Hematology Association (EHA) in Amsterdam -- ENESTop and ENESTfreedom -- show that about half of the patients who met the treatment discontinuation criteria during Tasigna administration maintained a significant molecular response (MMR) after four years.

Also, most of the patients treated with major MMR recovered, suggesting the possibility of TFR.

TFR means that patients with chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (PH + CML-CP) maintain an MMR without recurrence even after discontinuing targeted chemotherapy. The indication has become a new therapeutic target for chronic myelogenous leukemia.

Both ENESTop and ENESTfreedom studies are the clinical evaluations of MMR possibilities after Tasigna treatment discontinuation.

The 192-week study shows a consistent effect on the discontinuation of Tasigna treatment, compared to the previous 48 weeks, 96 weeks, and 144 weeks of data.

“This suggests long-term safety in the absence of disease progression, even when Tasigna treatment meets the discontinuation criteria and there is a potential for functional cure, even after major TFR loss of major MMRs,” the company said.

“The final goal of treating chronic myelogenous leukemia has been rapidly shifting to TFR, which maintains optimal gene response for a certain period after treatment with targeted anticancer therapy, and then stops treatment and precisely monitors progress,” said Professor Kim Dong-wook, head of St. Mary’s Hematology Hospital.

The study is meaningful in confirming the possibility that the treatment effect can be maintained without recurrence even if the treatment of the target cancer chemotherapy is stopped in some patients for a considerable period, Kim said.