UPDATE: Roche Cancer Drugs Show Positive Results

Roche Holding AG (ROG.VX) Monday said fresh trial results of two of its cancer medicines suggest the Swiss pharma giant's cancer therapies may improve treatment for women suffering from ovarian and breast cancer.

Roche said Avastin may be helpful in treating women with ovarian cancer, while its experimental medicine T-DM1 was shown to be as efficient as standard treatment, boosting the drugs' chances of being approved in these areas, analysts said.

"We are committed to developing new medicines that make a difference in the lives of people living with cancer," said Roche's Chief Medical Officer Hal Barron. "The clinical data presented today ... further demonstrate that Avastin in ovarian cancer and T-DM1 in HER2-positive breast cancer may improve the treatment of women with ovarian or breast cancer."

The data were presented at the European Society for Medical Oncology, or ESMO, meeting in Milan, which lasted from October 8 until October 11. At the same meeting, Roche also presented clinical trial results for its experimental lung cancer drug MetMab and for its already-marketed cancer medicine Tarceva. Both drugs helped improve patients' lives, Roche said.

Roche said a Phase 3 study of Avastin in ovarian cancer showed that patients who received Avastin in combination with chemotherapy and then continued solely with Avastin had about 27% improvement in the likelihood of living longer without the disease worsening compared to those women who received only chemotherapy.

Although the improvement rate was lower than in a previous Phase 3 study, Roche said Avastin was administered at a lower dose and for a shorter treatment duration than in the previous trial. The company added that the setup of the trial "allowed [for the] conclusion that continued use of Avastin for a longer treatment duration [would have] improved outcome."

While an improvement in the so-called progression-free survival rate is a key figure to assess the efficacy of a cancer treatment, analysts note regulators tend to focus on overall survival data when deciding whether to approve a drug. Roche said overall survival data for both Avastin studies were currently "immature".

The U.K. health regulator recently rejected reimbursement for Roche's Avastin to treat bowel cancer due to cost and efficiency concerns. The use of Avastin to treat breast cancer in the U.S. is also threatened as the U.S. regulator is deciding whether the drug's high cost are justified when compared to its limited ability to extend patients' lives.

Roche also said Phase 2 data on its experimental metastatic breast cancer medicine T-DM1 showed the drug to be as efficient in shrinking tumors as standard therapy, which uses Roche's cancer drug Herceptin and chemotherapy. Besides being efficient, T-DM1 also led to fewer side effects than standard therapy, Roche said.

T-DM1, which Roche's unit Genentech developed with Immunogen Inc (IMGN), is an antibody drug conjugate, a new therapy considered to be more effective than chemotherapy, especially in women with a specific form of breast cancer. Unlike in chemotherapy, where side effects are common as cancerous and healthy cells are destroyed, the new technology is more precise as cancer-killing agents are attached to an antibody that can be directly transported to affected cells.

Although the U.S. regulator rejected priority review for T-DM1, the drug's chances to be approved and open a fresh and more efficient avenue to treat cancer, are high, analysts said.

Analysts said that while the Roche data was generally positive, investor attention is currently focused on the company's cost-cutting plan, details of which are expected to be published as early as Thursday when Roche reports third-quarter sales. Due to a series of drug development setbacks, Roche is expected to slash sales and R&D costs.

Shares of Roche traded little changed on the Swiss stock exchange Monday afternoon.

-By Goran Mijuk, Dow Jones Newswires, [phone]; [e-mail]