Roche Holding AG (ROG)’s experimental breast cancer drug T-DM1 “significantly” extended the lives of breast cancer patients in a trial that may improve the likelihood of approval of the medicine.
Roche announced in March that the drug, a so-called antibody-drug conjugate that combines the company’s Herceptin with an older chemotherapy, delayed the disease from worsening in the late-stage study dubbed Emilia. T-DM1 has thus met both of the main goals of the trial, the Basel, Switzerland-based company said in a statement today.
The drugmaker, which gained Herceptin with its $46.8 billion purchase of Genentech Inc. in 2009, is developing T-DM1 with technology it licensed from Waltham, Massachusetts-based ImmunoGen Inc. (IMGN:US) Today’s results were important because European regulators had signaled they wanted proof the drug helps patients live longer before approving it, said Odile Rundquist, a Geneva-based analyst for Helvea SA.
“Antibody-drug conjugates are really the future of cancer therapy,” Rundquist said by phone. She estimates peak annual sales for T-DM1 of 1.6 billion Swiss francs ($1.67 billion).
Roche has applied to the U.S. Food and Drug Administration for approval of the medicine and said today it will “shortly” submit an application to the European Union’s drug regulator.
Today’s data is “taking it to the next step on the survival issue” and reinforces the quality of the patient testing of the drug, ImmunoGen Chief Executive Officer Dan Junius said in a telephone interview.
T-DM1 is a so-called “armed antibody” that combines Herceptin with DM1, which is derived from an older chemotherapy medicine called maytansine. That drug was found to be too toxic for patients in clinical trials two decades ago. ImmunoGen’s technology enabled chemists to fuse DM1 to Herceptin in such a way that it isn’t activated until Herceptin shepherds it directly to the cancer cell.
Roche rose 0.6 percent to 175.9 francs in Zurich. The stock has returned 15 percent this year including reinvested dividends, compared with a 16 percent return for the Bloomberg Europe Pharmaceutical Index.
The Emilia trial compared the drug with combined doses of GlaxoSmithKline Plc (GSK)’s Tykerb and Roche’s Xeloda in women who have a gene mutation that causes the body to create an excess of a protein called HER2.
About 25 percent of breast cancer cases are distinguished by HER2 on the surface of the cancer cells that causes them to multiply more quickly. Herceptin, which generated 5.3 billion francs in sales last year, latches on to HER2, interfering with it without killing the cell.
Patients in the trial who received the Tykerb-Xeloda combination will be offered T-DM1, Roche said. The company also will set up a program to provide the drug to U.S. patients under certain circumstances while Roche seeks regulatory clearance. The FDA rejected a request in 2010 to accelerate the approval process.
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