A study involving an experimental cancer drug being developed by Roche Holding (RHHBY, ROG.VX) showed it delayed disease progression in women with a specific type of breast cancer compared to conventional therapy.

The study involved a drug currently dubbed T-DM1, or trastuzumab emtansine, which combines Roche's cancer drug Herceptin with a chemotherapy drug in a medicine designed to be delivered directly to the cancer cell. Traditional chemotherapy drugs are designed to kill cancer, but they also affect healthy cells in the body.

Details from the study are scheduled to be presented Sunday at the American Society of Clinical Oncology's annual meeting on Sunday. Roche announced top-line data in March.

The study involved about 1,000 women with HER2-positive breast cancer who had been previously treated with Herceptin and a traditional chemotherapy drug. About half of the women were then treated with T-DM1 and the other half were treated with a combination of Xeloda, another Roche drug, and GlaxoSmithKline PLC's (GSK, GSK.LN) Tykerb. The drugs were administered every three weeks until the disease progressed or patients experienced unmanageable side-effects. The medicines are designed to treat women who test positive for the HER2 protein, a type believed to account for 20% to 25% of all breast-cancer cases.

"This is a completely new way of treating HER2-positive breast cancer," said Kimberly Blackwell, the study's lead researcher and a professor of medicine at Duke University.

The study was designed to measure progression-free survival, which is a measurement of the time from the start of treatment until the disease gets worse or the patient dies, and overall survival, which is a measurement of time from the start of treatment until death. So far patients in the study have been followed for about two years.

The median progression-free survival for patients receiving T-DM1 was 9.6 months, compared to 6.4 months in the group receiving Xeloda and Tykerb, a difference considered statistically significant.

The median overall survival two years after starting treatment was 23.3 months for Xeloda and Tykerb and had not been reached for patients in the T-DM1 group. Patients in the study are still being followed. At the two-year mark, 65.4% of T-DM1 patients were alive, compared to 47.5% of patients receiving Xeloda and Tykerb, researchers said.

The study showed more patients in the T-DM1 group had elevations in liver function tests and a blood disorder known as thrombocytopenia. More patients in the Xeloda and Tykerb group had dose reductions, diarrhea, vomiting and a condition called hand-foot syndrome which is redness, swelling and pain on the hands or feet.

Roche said it expects to file an application with the U.S. Food and Drug Administration and other regulators for T-DM1 by the end of the year.

Dr. Louis Weiner, the director of Georgetown University's Lombardi Comprehensive Cancer Center, who was asked to review the study by ASCO said "It looks like it is a useful regimen and looks like it will have powerful impacts on survival."

The technology that linked Herceptin with emtansine, which is a more powerful drug than traditional chemotherapy drug, was developed by ImmunoGen Inc. (IMGN) The company has its own drugs in development and is working with other companies including Bayer AG (BAYRY, BAYN.XE), Eli Lilly & Co. (LLY), Novartis AG (NVS, NOVN.VX) and Sanofi (SNY) to develop other combination cancer drugs that link antibodies designed to directly target the cancer cell with strong chemotherapy drugs.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; Jennifer.Corbett-Dooren@dowjones.com

Roche (QX) (USOTC:RHHBY)
Gráfico Histórico do Ativo
De Mai 2025 até Jun 2025 Click aqui para mais gráficos Roche (QX).
Roche (QX) (USOTC:RHHBY)
Gráfico Histórico do Ativo
De Jun 2024 até Jun 2025 Click aqui para mais gráficos Roche (QX).