#ASCO18: 1/2 Novartis treated leukemia ex-patients still in remission after 3 yrs

• ENESTop and ENESTfreedom data evaluate Treatment-free Remission (TFR) rates at 144 weeks among eligible Ph+ CML-CP patients who stopped Tasigna^® 
• Findings further support durability and safety of TFR with Tasigna; nearly all patients who lost TFR regained major molecular response after restarting therapy
• Novartis commitment to seek new solutions in CML continues with update of Phase III trial evaluating asciminib, an investigational BCR-ABL1 inhibitor

New Novartis data from two long-term Treatment-free Remission (TFR) studies in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase (CP) will be presented during the 54th Annual Meeting of the American Society of Clinical Oncology (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^® (nilotinib) therapy. The 144-week trials evaluate the potential to maintain molecular response (MR) after stopping therapy in eligible adult patients with Ph+ CML-CP.

“Treatment-free Remission is a new treatment goal in CML,” said François-Xavier Mahon, Cancer Center of Bordeaux, Institut Bergonié and lead investigator of ENESTop. “Clinical studies like ENESTop and ENESTfreedom offer evidence that when a Ph+ CML-CP patient achieves a deep molecular response with Tasigna, along with other eligibility criteria, s/he can attempt TFR and have a nearly 50% chance of remaining treatment-free long-term. These results confirm an exciting opportunity for eligible patients – the opportunity to reduce time on drug for a chronic leukemia.”

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[1]. 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 =< 0.0032%)[1]. Study authors stress that frequent 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[2].

“Novartis continues to redefine treatment options for Ph+ CML patients,” said Samit Hirawat, MD, Head of Novartis Oncology Global Drug Development. “The importance of achieving deep and sustained responses with Tasigna has been demonstrated in our TFR clinical program, which is the largest among all oncology companies. These long-term trials deliver on our commitment to the patient community to continue to look for more and better solutions for CML.”

An update on the Phase III clinical trial design for Novartis’ investigational BCR-ABL1 inhibitor, asciminib, will also be presented as part of the ASCO Scientific Program (Abstract #TPS7081).

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