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Roche has announced positive results from the pivotal Phase III ToGA trial of Herceptin (trastuzumab; Genentech/Roche/Chugai) in combination with chemotherapy in the first-line treatment of advanced gastric cancer. The trial randomized 594 HER-2-positive gastric cancer patients to receive a combination of Xeloda (capecitabine; Roche) or 5-fluorouracil with cisplatin, with or without Herceptin. The primary endpoint of the trial was improved overall survival. Roche announced that Herceptin prolonged the life of patients, but exact details regarding the specific survival benefit have not been disclosed.
Gastric cancer is the second biggest cause of cancer-related mortality worldwide. Datamonitor forecasts the incidence of gastric cancer in the seven major pharmaceutical markets to exceed 197,500 in 2009. Gastric cancer is generally associated with a poor prognosis and a relatively high mortality rate, especially in the advanced stages of the disease. The standard treatment for advanced disease is combination chemotherapy, which generally confers an overall survival time of up to 11 months.
If Herceptin is approved for use in HER-2-positive advanced gastric cancer, it could become the first molecular targeted therapy to gain approval in this indication. However, the requirement of HER-2 expression in the relatively small gastric cancer population will minimize Herceptin's overall potential patient base. Of the 3,800 patients initially screened for the ToGA trial, only about 15% were HER-2-positive.
Herceptin could also face competition from other late-phase pipeline products such as Avastin (bevacizumab; Genentech/Roche/Chugai) and Erbitux (cetuximab; ImClone/Merck Serono/Bristol-Myers Squibb), which are also being evaluated in the first-line setting of advanced gastric cancer. While the competitive threat from these drugs remains to be seen, a clinically significant survival advantage could establish Herceptin as a favorable therapy in the selected HER-2-positive population, thereby further boosting the drug's already substantial sales.
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