The combination of GlaxoSmithKline (NYSE:GSK) breast cancer drug Tykerb with a drug from rival Roche (OTC:RHHBY) works better compared to using either drug as a standalone therapy, according to a new study.
The findings could boost the treatment options for patients and the marketing potential for Tykerb, which falls well short of the Roche drug Herceptin in terms of global sales. Just last September, GSK halted part of a phase 3 trial studying Tykerb after an independent committee concluded that Tykerb administered alone was unlikely to work better than Herceptin. But British pharma giant GSK, which maintains its U.S. headquarters in Research Triangle Park, North Carolina, opted to continue studying Tykerb, also called lapatinib, in some combination with Herceptin, known also as trastuzumab.
Dr. Jose Baselga, chief of oncology at Massachusetts General Hospital Cancer Center, led the study. Results of the GSK-funded study are published in the Jan.17 issue of The Lancet. Researchers said that the two drugs inhibit growth of human epidermal receptor 2, or HER2, a protein that promotes cancer cell growth. The Tykerb-Herceptin study enrolled 455 patients in 23 countries. The patient group given a combination of Tykerb and Herceptin showed a 51.3 percent response rate. By comparison, the group given Herceptin alone showed a 29.5 percent response rate; Tykerb alone produced a 24.7 percent response rate.
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“This is the first demonstration that adding a second anti-HER2 therapy, lapatinib, to trastuzumab is superior to trastuzumab alone in patients with early breast cancer,” Baselga said in a statement. “It opens up the concept of dual HER2 blockade as a better approach for patients with early, nonmetastatic, HER2 breast cancer.”
Tykerb received U.S. Food and Drug Administration approval in 2007. The drug generated more than $360 million in 2010 revenue, well short of the more than $6 billion in global Herceptin sales. GSK has been conducting additional Tykerb research in an effort to expand the drug’s sales potential.
Herceptin is currently approved in the United States for postoperative treatment and in Europe for both pre- and postoperative therapy. Tykerb is approved for use in combination with chemotherapy for patients whose tumors have stopped responding to Herceptin. Since Tykerb and Herceptin have different mechanisms of action, combination therapy is being investigated to reduce the development of cancer that resists current treatments.