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Roche's Herceptin follow-up meets targets in phase III

Positive step for cancer drug in race to market ahead of Herceptin patent expiry

Roche Basel Switzerland

Roche has presented data from its phase III programme for T-DM1 demonstrating that the drug extends progression-free survival in patients whose breast cancer has advanced despite earlier treatment with Herceptin.

T-DM1 (trastuzumab emtansine) is an antibody-drug conjugate (ADC) in development at Roche's Genentech unit as a follow-up to $6bn-a-year blockbuster Herceptin (trastuzumab), and the company is racing to get it to market before the latter drug starts to lose patent protection in 2015.

On the strength of the new data Roche has reiterated plans to file for approval of the new drug in Europe and the US later this year.

The results of the EMILIA study were presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago by Kimberly Blackwell of Duke University Medical Centre, who said that the new drug is likely to become "a very important therapeutic option for patients with HER2-positive metastatic breast cancer".

Progression-free survival rose by 35 per cent with T-DM1 - an increase of 3.2 months - compared to a rival regimen based on GlaxoSmithKline's Tykerb/Tyverb (lapatinib) plus Roche's own Xeloda (capecitabine).  The trial enrolled patients with HER2-positive metastatic breast cancer who had previously been treated with Herceptin and taxane-based chemotherapy.

Overall survival improved 38 per cent, but did not reach threshold for statistical significance, said the EMILIA investigators. They noted however that follow-up of patients continues, so a definitive conclusion on this endpoint has not been reached.

Meanwhile, side effects from T-DM1 were also less severe, with fewer people on the drug experiencing a grade three or higher adverse reaction.

T-DM1 combines the tumour-targeting properties of trastuzumab with a potent cell-killing component (emtansine), which Roche has licensed from US company ImmunoGen.

EMILIA was just one of several trials of new ADC products at ASCO which promise to deliver improvements in cancer therapy. Genentech has eight other ADCs in clinical development.

6th June 2012

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