Roche Touts Drug For ESMO

Roche Drug T-DM1 Outdoes Herceptin With Chemotherapy

By Rob Waters - Oct 8, 2010 3:02 PM ET Tweet (1)LinkedIn Share

Roche Holding AG said its two-drug treatment combining an anticancer agent with Herceptin, the company’s $5.27-billion breast cancer drug, was about as effective as, and caused fewer side effects than, Herceptin with chemotherapy.

The results, presented at the European Society for Medical Oncology meeting in Milan, were the first to measure the effectiveness of Roche’s experimental drug called trastuzumab- DM1 as an initial therapy in patients with a particular subtype of breast cancer. T-DM1 is a member of a new class of experimental drugs called antibody-drug conjugates that combine antibodies and anticancer drugs.

If these medicines prove effective, they may enable doctors to avoid using a toxic chemotherapy drug that circulates throughout the body, said Krysta Pellegrino, a spokeswoman for Roche’s Genentech unit. T-DM1 is being developed by Basel, Switzerland-based Roche, the world’s biggest maker of cancer treatments, with Waltham, Massachusetts-based Immunogen Inc.

“This points to the promise of antibody-drug conjugates,” Pellegrino said in a telephone interview today from Genentech’s headquarters in South San Francisco. “This is targeted delivery, compared to the systemic exposure of chemotherapy.”

In T-DM1, trastuzumab, the active ingredient in Herceptin, binds with cancer cells to deliver a cancer-killing agent directly to the target, Pellegrino said.

Roche closed unchanged today at 139.1 Swiss francs in Zurich trading, and has declined 17 percent in 12 months.

Six-Month Results

In the study, 137 women with a genetic subtype of breast cancer known as HER2-positive were treated with the standard therapy of Herceptin plus chemotherapy or with T-DM1.

After six months, 48 percent of women treated with T-DM1 had their tumors shrink compared with 41 percent of those taking the combination of Herceptin and Taxotere, a chemotherapy drug sold by Paris-based Sanofi-Aventis SA. Among the women taking the standard therapy, 75 percent had side effects of grade 3 or higher on a 5-point scale, compared with 37 percent of those getting T-DM1, according to the research. C

U.S. approval for T-DM1 may be delayed until about mid- 2012, Roche said in a statement on Aug. 27. Another company, Seattle Genetics Inc. of Bothell, Washington, is also developing antibody-drug conjugates, including one for lymphoma.

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