Novartis has presented more late-stage data which shows that Tasigna, its relatively new treatment for chronic myeloid leukaemia, is more effective than the Swiss firm’s own blockbuster Glivec.

Novartis says that Tasigna (nilotinib) met its primary endpoint in the first head-to-head comparison with Glivec (imatinib) and produced faster and deeper responses when given as first-line therapy for adults with newly diagnosed Philadelphia chromosome-positive CML in chronic phase. The Phase III trial was designed to detect a difference in major molecular response (MMR) between Tasigna and Glivec after 12 months of treatment and is the first study in which molecular traces of a key biomarker specific to Ph+ CML.

David Epstein, chief executive of Novartis Oncology, said the firm developed Tasigna to be a potent and selective inhibitor of the protein Bcr-Abl,, “with the goal of eliminating the underlying cause of Ph+ CML”. He added that “we now know that Tasigna reduces the level of Bcr-Abl faster and to a lower level than Glivec, noting that molecular monitoring “enables us to evaluate whether patients have achieved this deep level of CML residual disease, reducing the fundamental biomarker of leukemia to nearly undetectable levels”.

Glivec is still a huge earner for Novartis and sales in the second quarter for the drug, which is also approved for gastrointestinal stromal tumours, were up 5% to $990 million. However the firm is already laying the groundwork for when the treatment goes off-patent, starting in 2015.

Canakinumab shows promise in gout
Meantime, Novartis has also presented new Phase II results which show that its biological therapy ACZ885 (canakinumab) “is significantly more effective" than the injectable corticosteroid triamcinolone for gout. At the end of the eight-week study, the risk of flare recurrence was 94% less for patients on canakinumab than on the steroid, according to data presented at the American College of Rheumatology meeting in Philadelphia.

The drug is already being sold in a number of markets, including the USA, for the treatment of cryopyrin-associated periodic syndrome (CAPS), a rare life-long auto-inflammatory disease, under the brandname Ilaris. If canakinumab proves to be a successful treatment for gout, sales will receive a massive boost.