Phase III trial results suggest that GlaxoSmithKline's oral treatment Tykerb (lapatinib) plus capecitabine, which Roche markets as Xeloda, nearly doubled the time to disease progression in women with refractory advanced or metastatic HER2-positive breast cancer whose disease had progressed after treatment with Roche's Herceptin (trastuzumab) and other cancer drugs, compared to those who received Xeloda alone. The data were presented at ASCO.
The interim analysis included data from 321 trial participants who were randomised to receive either Tykerb plus Xeloda, or Xeloda alone. Researchers found that in the 160 patients who received the combination treatment, the time to disease progression was 36.9 weeks, compared to 19.7 weeks for the 161 patients receiving Xeloda alone. An additional analysis of the interim data showed that fewer patients in the combination arm saw their cancer spread to the brain, compared to patients receiving Xeloda alone.
Lead author Dr. Charles Geyer, from Pittsburgh's Allegheny General Hospital, remarked that "we believe Tykerb and Xeloda is an effective new regimen and should be considered a new standard of care," Bloomberg reports. Meanwhile, Dr. Eric Winer, a breast cancer specialist at the Dana-Farber Cancer Institute, commented that the "results are quite impressive and clearly more impressive than any of us would have expected," The New York Times reports.
Sanford Bernstein analyst Gbola Amusa predicted that if approved, the treatment could generate $1.5 billion in annual sales by 2012. The analyst added that the experimental drug may eventually be used in combination with Herceptin to treat all forms of HER2-positive breast cancer, and could be "key" in transforming breast cancer from a fatal disease to a chronic condition, CNN Money reports.
Glaxo's CEO Jean-Pierre Garnier noted that Tykerb is proof that the company's R&D structure, which includes several "centres of excellence for drug discovery" each focused on a therapeutic area, "is working," The Telegraph reports. "The entrepreneurial approach of our oncology [centre of excellence] means that we had the focus and vision to see through the true potential of Tykerb," Garnier added. The drugmaker plans to file Tykerb with EU and US regulators in the second half of the year.
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