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Roche to file Herceptin follow-up T-DM1 on new data

Positive phase III trial shows drug can extended progression-free survival in people with HER2-positive metastatic breast cancer

Roche Herceptin trastuzumab cancer

Roche has taken a critical step forward in defence of its breast cancer portfolio after saying it will file for approval for a follow-up to its top-selling Herceptin (trastuzumab) product during 2012.

Top-line results from a phase III trial of T-DM1 (trastuzumab emtansine) are positive and put the company on track to submit the drug in the US and Europe in the coming months.

This gives Roche an opportunity to build a market for the new drug before Herceptin starts to lose patent protection in 2015.

The EMILIA trial showed that T-DM1 significantly extended the time people with HER2-positive metastatic breast cancer lived without their disease getting worse.

The study enrolled 991 people with HER2-positive metastatic breast cancer who had previously received treatment with Herceptin and taxane-based chemotherapy, and compared Roche's drug as a monotherapy GlaxoSmithKline's Tykerb/Tyverb (lapatinib) plus Roche's own Xeloda (capecitabine).

Progression-free survival was significantly longer in the T-DM1 group, according to Roche, and the company is now waiting to see if this translates to an increase in overall survival, which is the other main endpoint in the study. Safety data was consistent with the findings of earlier studies of the drug.

T-DM1 is an antibody-drug conjugate (ADC), a relatively new class of drug which is attracting considerable attention in oncology.

It is Roche's first ADC, according to the company's chief medical officer Hal Barron, and uses the trastuzumab antibody to target HER2-positive breast cancer cells whilst delivering an additional chemotherapy offering in the form of ImmunoGen's DM1 compound.

The antibody component blocks the signals that make HER2-positive cancer cells more aggressive and sends a message to the patient's immune system to destroy the cancer cells. It also delivers the DM1 agent directly to tumour cells to induce cell death.

This approach "may help people who still need more treatment options for this aggressive disease", said Barron. "We will work to submit these data to regulatory authorities as quickly as possible."

Herceptin is Roche's second-biggest product with sales of 5.25bn Swiss francs ($5.82bn) last year, accounting for 15 per cent of the pharma company's total product revenues.  Analysts have suggested that T-DM1 could achieve $1bn or more in sales at peak.

Meanwhile, Roche is developing additional products intended to protect its Herceptin franchise, including a subcutaneous formulation of the drug partnered with Halozyme Therapeutics which is also scheduled for filing in 2012.

2nd April 2012

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