UPDATE 1-Novartis says trial results back Tasigna drug

Mon Dec 10, 2012 6:15pm EST

* Late-stage data being presented at ASH meeting

* Novartis banking on Tasigna to replace older drug Glivec

* Drugmaker plans trials to explore treatment free remission

ZURICH, Dec 10 (Reuters) - Novartis AG's blood cancer drug Tasigna is better at treating a type of chronic myeloid leukemia than its older drug Glivec, according to data from two late-stage trials, boosting prospects for its oncology franchise.

Novartis is hoping to convince doctors to switch patients to Tasigna to shield its sales once Glivec, one of its best-selling medicines, loses patent exclusivity in 2015.

The latest data, which are being presented at the American Society of Hematology's (ASH) annual meeting, examined the benefits of Tasigna in patients with Philadelphia chromosome-positive chronic myeloid leukemia.

Two-year data from the ENESTcmr trial showed patients who still had evidence of residual disease after long-term treatment with Glivec achieved undetectable levels of the disease after switching to Tasigna.

More than twice as many patients treated with Tasigna continued to show undetectable levels of the disease compared with Glivec, according to the data. Novartis said the results were statistically significant.

Meanwhile, four-year data from the ENESTnd trial showed more than three times as many patients being treated with Tasigna as a frontline therapy experienced a reduction in the level of disease versus Glivec, marketed as Gleevec in the United States.

Novartis plans to start a clinical trial in early 2013 to test whether some patients may be able to stop treatment after achieving a sustained response to therapy.

Other data also presented at ASH showed that Novartis' drug Jakavi - which gained EU approval in August - significantly reduced the disease burden in patients with myelofibrosis, a rare blood cancer with limited treatment options.

Follow up data from a late-stage study showed that nearly half of patients treated with Jakavi achieved a reduction of at least 35 percent in spleen volume, Novartis said.