Novartis publishes first results for “promising” leukaemia drug

Novartis has released the first details of a phase I clinical trial for Tasigna, a targeted therapy for an unresponsive form of chronic myeloid leukaemia (CML), which can be fatal.

Most cases of CML are caused by a genetic abnormality in the Philadelphia (Ph) chromosome, caused by a protein called Bcr-Abl. Tasigna is designed to inhibit Bcr-Abl and therefore effectively shut down the Ph chromosome that causes the production of abnormal, cancerous white blood cells.

The trial included 33 patients in blast crisis (a high-mortality advanced stage of CML characterised by the production of large amounts of immature white blood cells), 56 patients in the accelerated phase (when the disease progresses quickly), and 17 patients in the chronic phase of the disease.

According to Novartis, in over a third of these patients the Ph chromosome was “undetectable” after treatment with Tasigna. The drug was compared to Glivec, which is another Bcr-Abl inhibitor but is thought to less selective than Tasigna.

Hago Kantarjian, professor of medicine and internist, chair of the department of leukaemia at the MD Anderson Cancer Centre, remarked: “By selectively inhibiting Bcr-Abl and its common mutations, Tasigna produced dramatic positive responses in patients who had limited treatment options.”

“These extremely encouraging results reinforce the validity of treating this cancer by specifically targeting the one protein known to cause the disease,” he added.

Last week, Novartis announced that nine out of ten patients who used Glivec are “still alive after five years”. It found that 93 per cent of patients in early-stage CML did not progress into further stages of the disease, while under five per cent of patients died from leukaemia-related causes during their treatment.

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