Replies to post #105220 on Biotech Values

[mcbio]

IMGN - ESMO T-DM1 data

http://www.reuters.com/article/idCNLDE6971Y320101008?rpc=44

UPDATE 1-Roche's cancer drug T-DM1 shows promise in study

* T-DM1 has fewer side-effects than standard care

* New drug seen as follow on to blockbuster Herceptin

MILAN/ZURICH, Oct 8 (Reuters) - Roche Holding AG's (ROG.VX) experimental cancer drug T-DM1 is more effective than older therapies, with substantially fewer side-effects in breast cancer, giving the Swiss drugmaker's pipeline a much needed boost.

Researchers at this year's Congress of the European Society for Medical Oncology (ESMO) in Milan said T-DMI had shown encouraging activity as a first-line therapy in HER2-postive metastatic disease.

Roche, the world's largest maker of cancer drugs, has had a tough year so far as its drug development pipeline has been hit by a number of setbacks and top-selling Avastin has stumbled at a number of hurdles, knocking investor confidence in the group.

But the T-DM1 data is likely to go some way to restoring investors' faith in the group's pipeline as it shows the drug, viewed inside Roche as a key product, could still come to the market to improve established blockbuster Herceptin.

Researchers found an overall response rate of 48 percent in patients given T-DM1, compared with 41 percent in the Herceptin, or trastuzumab, plus docetaxel arm, researchers said in a statement.

"Importantly, the rates of clinically relevant adverse events were significantly lower in the T-DM1 arm compared to the rate in women given trastuzumab plus docetaxel," the researchers said.

T-DM1's image was tarnished in August when U.S. regulators rejected Roche's bid to gain marketing approval based only mid-stage Phase II trials.

T-DM1, which Roche developed with U.S. biotech group ImmunoGen (IMGN.O), is also the first of a new kind of "armed antibody" that can carry a cell-killing payload into cancer cells.

"We are encouraged by the results. The study demonstrated that T-DM1 has very good anti-tumour activity as well as much lower toxicity when evaluated side by side to the older 'standard'," Edith Perez, principal investigator of the study said in a statement issued on Friday.

ESMO released data on the drug early because an embargo was broken. (Reporting by Katie Reid; Editing by David Cowell)