Roche reported that Herceptin (trastuzumab) decreased the risk of death in patients with HER2-positive advanced stomach cancer by 26 percent, compared to chemotherapy alone, according to findings from a Phase III study. The additional details, presented at ASCO, follow the company’s announcement earlier this year that the trial had met its primary endpoint of improving overall survival. ASCO’s president, Richard Schilsky, remarked that the data will change medical practice and “will force us to test patients for HER2, treat patients who are HER2-positive, and conduct research on gastric cancer that is HER2-positive.”
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The randomised ToGA study enrolled 594 patients with inoperable locally advanced, recurrent and/or metastatic HER2-positive gastric cancer, who received first-line treatment with either Herceptin plus chemotherapy, or chemotherapy alone. Data showed that patients in the Herceptin arm had a median overall survival time of 13.8 months, compared to 11.1 months for those in the chemotherapy-only group. Furthermore, Roche stated that patients with tumours exhibiting high levels of HER2 lived 16 months on average when Herceptin was added to treatment with chemotherapy.
Principal investigator Eric Van Cutsem commented that “this is the first Phase III study to report improved overall survival with a personalised, targeted treatment for gastric cancer” and “the first time a biological [drug] has improved survival in gastrointestinal cancer.” He also noted that Herceptin reduced the size of tumours and increased survival significantly beyond the one-year mark that has been a hurdle for patients with advanced gastrointestinal tumours.
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Corinne Wolter remarked that the drugmaker will file Herceptin, which is currently approved for the treatment of breast cancer, for regulatory approval in the stomach cancer indication in countries outside the US. Spokesperson Kristina Becker of Genentech said a decision to file for expanded approval with the FDA is under review. Nomura analyst Amit Roy estimated that approval of Herceptin in patients with HER2-positive stomach cancer could add $450 million to the product’s annual worldwide sales, which exceeded $4.7 billion last year.
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