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Celgene stops trial of Revlimid in prostate cancer

Phase III study halted after no overall survival benefit found

Celgene suffered a setback yesterday after it was forced to discontinue a phase III trial of its cancer drug Revlimid.

The MAINSAIL study found no overall survival benefit for Revlimid (lenalidomide) in castration-resistant prostate cancer patients when Celgene's drug was added to a standard regimen of docetaxel and prednisone.

Revlimid is already approved for the treatment of relapsed and refractory multiple myeloma in nearly 70 countries around the world - as well as for transfusion-dependent anaemia in a subset of myelodysplastic syndrome (MDS) patients in the US, Canada and some Latin American markets.

These are relatively rare conditions, and Celgene had been hoping to get Revlimid approved in a new indication with a larger target population, particularly as one of its other key products - Vidaza (azacitidine) for MDS - is facing generic competition in the US.

That said, Revlimid has already been a massive commercial success for Celgene, on target to bring in more than $3bn in revenues in 2011.

Third-quarter sales were $820m, a rise of 28 per cent on the same period of 2010 thanks to a trend towards physician prescribing Revlimid for longer periods, and the drug now holds around 52 per cent of the US multiple myeloma market.

Celgene is also pursuing registrations for Revlimid in newly-diagnosed multiple myeloma (NDMM) patients and as a maintenance therapy in this indication, and is hoping for EU approval in the first half of 2012. A US filing in NDMM will follow later that year.

The company also has phase III trials of Revlimid in chronic lymphocytic leukaemia (CLL) and non-Hodgkin's lymphoma patients, as well as early-stage studies in acute myeloid leukaemia.

Despite the prostate cancer trial disappointment Celgene also has active, recruiting phase I to II trials in other solid tumours, notably brain, ovarian, bladder, kidney, prostate and head and neck cancers.

23rd November 2011

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