Novartis data shows Treatment-free Remission rates are consistently above 50% regardless of reason for switch to Tasigna® from Glivec® - Seite 2

ENESTop is part of a larger Tasigna TFR clinical trial program to evaluate the potential to maintain molecular response after stopping therapy in adult patients with Ph+ CML in the chronic phase who achieved a sustained deep level of molecular response with Tasigna. In the primary analysis of ENESTop, nearly 6 out of 10 (57.9%) patients (95% CI, 48.8%-66.7%) who achieved a sustained deep molecular response following at least three years of Tasigna therapy maintained a molecular response 48 weeks after stopping treatment[3]. No new major safety findings were observed in ENESTop in patients treated with Tasigna beyond those in the known safety profile of Tasigna. The rates of all grade musculoskeletal pain were 42.1% in the first year of the TFR phase versus 14.3% while still taking Tasigna in the consolidation phase. No patients progressed to advanced phase/blast crisis. These results were previously presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and the Annual Congress of European Hematology Association (EHA) in June 2016. Results from additional studies in the Tasigna TFR clinical trial program were also presented at ASH in poster sessions, including ENESTpath (Abstract #3094) and ENESTfreedom (Abstract #3066).

"Our mission at Novartis is to help transform cancer therapy through bold science and innovation, and there is no better example of this than our support of eight TFR studies in patients with CML," said Bruno Strigini, CEO of Novartis Oncology. "Our further exploration of results from the ENESTop trial, beyond the primary analysis, reinforces our ongoing commitment to CML patients and contributes to the growing body of science that goes into treating this cancer."

Regular and frequent molecular monitoring with a well-validated assay able to measure BCR-ABL transcript levels down to MR4.5 is an important part of Tasigna TFR studies. Frequent patient monitoring during TFR allows timely determination of loss of MR4.0 or major molecular response (MMR) and the need for treatment initiation[3].

Stopping CML treatment is currently not a clinical recommendation and should only be attempted in the context of a clinical study. Discontinuation of treatment in ENESTop was conducted under the conditions of the trial and in patients who met the rigorous predefined criteria of the trial[3].

Novartis commitment to CML
Novartis is supporting eight studies as part of its TFR clinical trial program, which includes ENESTop, as well as three other ongoing company-sponsored TFR studies and four investigator-initiated studies that are now underway in more than 100 global sites across 40 countries. Over the past several decades, Novartis research in Ph+ CML has helped transform the disease from a fatal leukemia to a chronic condition and, today, the company continues its long-standing commitment to the global CML community. Novartis follows the science and builds upon existing evidence to explore what could be the next major contribution in the treatment of Ph+ CML through these TFR trials as well as investigational compounds.