Novartis Presents New Data From Two Long-term Treatment-free Remission Studies

(RTTNews) - New Novartis data from two long-term Treatment-free Remission or TFR studies in patients with Philadelphia chromosome-positive or Ph+ chronic myeloid leukemia or CML in the chronic phase or CP will be presented during the 54th Annual Meeting of the American Society of Clinical Oncology or ASCO in Chicago.

Results from the open-label Phase II trials, ENESTop and ENESTfreedom, show sustained TFR in patients treated with both front-line and second-line Tasigna or nilotinib therapy. The 144-week trials evaluate the potential to maintain molecular response or MR after stopping therapy in eligible adult patients with Ph+ CML-CP.

Data from ENESTop, presented today in an oral session (Abstract #7003) show that approximately half (48.4%; CI 95%, 39.4%-57.5%) of patients with Ph+ CML-CP who are eligible to stop second-line Tasigna therapy maintained disease remission over a prolonged period of time in the absence of treatment at 144 weeks of follow up, almost 3 years.

Patients in this trial took Tasigna following a switch from Glivec(?) (imatinib)*. ENESTop data also show that of the patients who restarted Tasigna due to loss of major molecular response (MMR=BCR-ABL/ABL <=0.1% IS), during the study period, nearly all (97.1%) regained MMR and 95.8% regained MR(4.5) (BCR-ABL1 IS =scheduled and compliant monitoring is necessary to assess for loss of response.

Results of ENESTop at 144-weeks are consistent with previously reported data at both 96- and 48-weeks.

A second long-term clinical trial, ENESTfreedom, is also part of the ASCO Scientific Program this week. The authors will report on TFR results at 144 weeks in patients who started front-line CML therapy with Tasigna. Results from ENESTfreedom will be shared with ASCO attendees on Monday, June 4 (Abstract #7063). In this trial, researchers found that almost half (46.8%; CI 95%: 39.6%-54.2%) of Ph+ CML-CP patients eligible to stop Tasigna treatment remained in MMR following treatment discontinuation.