Roche ($RHHBY) has turned in positive data from a key Phase III study of its blockbuster hopeful T-DM1 and later this year plans to seek green lights to sell the breast cancer drug in the U.S. and Europe, the company announced today.
The Swiss drug giant revealed top-line results from its 991-patient "EMILIA" study, saying that T-DM1, or trastuzumab emtansine, met one of the main goals of the study in providing a significant boost in survival without patients' cancer getting worse compared with patients who took the two cancer drugs lapatinib and Xeloda. The company didn't have available data on overall survival, which is the second primary endpoint of the study. Detailed results of the trial are expected at an upcoming scientific meeting.
Roche, which boasts the world's largest cancer drug business, sees T-DM1 as an encore to its drug Herceptin in treating HER-2 breast cancers, which account for 15% to 20% of all breast cancers. The experimental drug links Herceptin, an antibody drug, to the chemo agent DM1, providing what the company hopes will be a one-two punch that is more powerful in combating breast cancer than Herceptin or even Herceptin and separate doses of chemo. All patients in the EMILIA trial were previously treated with Herceptin and chemo.
The FDA turned down Roche's early bid for approval of T-DM1 in 2010, saying that the company's Phase II data weren't enough to win the agency's stamp. Roche is obviously upbeat about going back to regulators this year with Phase III results added to its data package for the program.
"We are excited about the EMILIA results because trastuzumab emtansine is our first antibody drug conjugate, and it may help people who still need more treatment options for this aggressive disease," Dr. Hal Barron, Roche's chief medical officer and head of product development, stated. "We will work to submit these data to regulatory authorities as quickly as possible."
ImmunoGen ($IMGN), which licenses its linker tech and the chemo agent for T-DM1 to Roche, could get its first revenue from sales of an antibody-drug conjugate if the drug is approved. To date, the Waltham, MA-based biotech relied on revenue from partnerships with Roche, Sanofi ($SNY), Eli Lilly ($LLY) and others. Biotech commentator Adam Feuerstein noted on Twitter this morning that ImmunoGen's royalty on T-DM1 sales is 5%.
Corrected and updated: ImmunoGen doesn't license T-DM1 to Roche, as initially reported in this article. ImmunoGen licenses the linker technology and chemo agent DM1 used for T-DM1 to the drug company. We apologize for any confusion. The story was updated after the correction to add that ImmunoGen also licenses DM1 to Roche.