Novartis reports better response with higher Glivec dose

Novartis has announced the results of an international clinical trial showing the administration of a higher initial dose of Glivec (imatinib) in patients with chronic myeloid leukaemia (CML) results in better early responses.

The company said the efficacy and safety profile of the compound in the phase III Tops study was consistent with the landmark Iris trial that established the drug as the standard of care.

While the study did not meet its one-year primary endpoint of a statistically significant major molecular response, it did show faster time to molecular responses with an 800mg dose compared to 400mg.

Novartis said the study reinforces the importance of monitoring blood levels to help customise treatment to benefit patients, while the firm restated its commitment to enhancing first-line treatment with further studies and enrolment in the trial comparing Glivec and Tasigna (nilotinib).

Diane Young, head of global medical affairs in oncology at Novartis, said: “Our robust clinical program with Glivec continues to provide meaningful insights into the treatment of Ph+ CML and other types of cancer.”

She added that the company is continuing to invest in trials to build on its knowledge and improve treatment outcomes for patients.

In December 2007, Novartis announced new data showing that Glivec can halt progression into the advanced stages of leukaemia into six years of treatment with the drug.