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Roche says skin cancer drug substantially shrinks

Sep 24, 2011, 10:19 a.m.

By Kate Kelland

STOCKHOLM (Reuters) - A new skin cancer drug from Roche had "remarkable" results in a mid-stage trial, substantially shrinking tumors and lesions in patients with a potentially fatal type of skin cancer, the Swiss drugmaker said on Saturday.

Full results from a mid-stage phase II trial presented at the European Multidisciplinary Cancer Congress (EMCC) in Stockholm showed Roche's vismodegib shrank tumors or healed lesions in 43 percent of people with locally advanced basal cell carcinoma (BCC) and 30 percent of those with another advanced form of disease.

"It is hard to appreciate, unless you have seen the photos, how remarkable the results really are," Sandra Horning, Roche's global head of clinical development in hematology and oncology, told reporters at the congress.

"These are individuals who have really severe disfiguring disease, often on the face, in a way that makes it very difficult for them to go out in public. The remarkable improvement in their appearance is really heartening and is clearly indicative of an improvement in quality of life."

Basal cell carcinoma is the most common type of skin cancer in Europe, Australia and the United States and there are about 2 million cases worldwide. It is usually treated with surgery and generally thought to be curable when the cancer is restricted to a small area of the skin.

But advanced cases of the disease, or those which have spread and led to secondary tumors, can weaken or disfigure sufferers and can ultimately be life-threatening. These cases are not always treatable with surgery and there is currently no medical treatment available.

Vismodegib is a type of drug called a "Hedgehog pathway inhibitor." The Hedgehog signaling pathway is important in regulating proper growth and development in the early stages of life and then becomes less active in adults. Mutations in the pathway that reactivate Hedgehog signaling are seen in several different types of cancer, including BCC.

"This pathway is activated in more than 90 percent of patients with basal cell carcinoma," Horning said.

Roche said earlier this month it had applied for approval to market its vismodegib in the United States for the treatment of skin cancer.

Horning said a similar application for approval in Europe was "in progress."

Its partner, Curis, is eligible to receive milestone payments and royalties under a collaboration agreement on the drug.

The phase II trial reported at the EMCC involved 104 patients in the United States, Europe and Australia. The data showed 7 patients died during the trial, but none of these deaths was related to the drug.

Serious side effects, or so-called "serious adverse events," were reported by 26 patients, and researchers said four patients reported serious adverse events related to vismodegib.

(Editing by Dan Lalor, John Stonestreet)

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