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Novartis and Merck halt late-stage studies

Novartis is discontinuing a phase III trial of an investigational treatment for gastrointestinal stromal tumours (GIST) based on the recommendation of an independent data monitoring committee

Novartis is discontinuing a phase III trial of an investigational treatment for gastrointestinal stromal tumours (GIST) based on the recommendation of an independent data monitoring committee. The committee determined after reviewing interim data that the drug, Tasigna (nilotinib), is unlikely to show superiority to Novartis' Glivec (imatinib), the current standard of care for the rare stomach cancer.

Tasigna is already marketed as a treatment for Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in adults who are newly diagnosed; are no longer benefiting from other treatments, including Glivec; or cannot tolerate other treatments.

The phase III trial had been investigating Tasigna as a first-line treatment in adult patients with unresectable and/or metastatic GIST, with a primary endpoint of progression-free survival versus Glivec. The study was begun in 2009 and had aimed to eventually enrol more than 700 GIST patients worldwide.

The article 'Getting the GIST' has further information on developments in GIST treatments.

Meanwhile, Merck and its partner Intercell announced that they are suspending a phase II/III trial of an investigational vaccine for the prevention of Staphylococcus aureus (S. aureus) infection also based on the recommendation of an independent data monitoring xommittee.

The committee made its recommendation after a pre-specified interim analysis that suggested that, although the trial did not meet the pre-specified futility criteria, the benefit/risk profile of the vaccine candidate needs to be evaluated before the study continues.

Merck and Intercell plan to provide an update on the vaccine candidate, currently known as V710, after further analysis of the data. The two companies have been collaborating on a number of vaccines since 2001.

S. aureus is a leading cause of hospital-acquired infections that can be deadly and are often resistant to multiple antibiotics, according to the companies.

12th April 2011

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