FDA approves Herceptin for HER2-positive metastatic stomach cancer

RocheRoche (SIX: RO, ROG; OTCQX: RHHBY) announced the U.S. Food and Drug Administration (FDA) has approved Herceptin (trastuzumab) in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil [5-FU]) for HER2-positive metastatic cancer of the stomach or gastroesophageal junction, in men and women who have not received prior medicines for their metastatic disease.

People diagnosed with metastatic stomach cancer should have the HER2 status of their tumors determined, as only patients with HER2-positive disease are eligible for treatment with Herceptin plus chemotherapy.

"Since Herceptin's approval in HER2-positive, advanced breast cancer more than a decade ago, we have continued to study how the HER2 pathway contributes to the growth and spread of other cancers, such as stomach cancer," said Hal Barron, M.D., Head of Global Development and Chief Medical Officer at Roche. "Today's approval of Herceptin in combination with chemotherapy provides an important new, personalized medicine for people with this life-threatening disease, who have few treatment options."

The European Commission approved Herceptin in combination with chemotherapy for use in patients with metastatic stomach (gastric) cancer exhibiting high levels of HER2, in January 2010.

About the ToGA study
The FDA approval is based on positive results from an international Phase III study, known as ToGA, which showed that people who received Herceptin plus chemotherapy lived longer compared to those who received chemotherapy alone.

ToGA enrolled 594 patients with locally advanced or metastatic, HER2-positive stomach cancer who were randomized to receive Herceptin plus chemotherapy (cisplatin plus either capecitabine or 5-FU) or chemotherapy alone. Results from the final overall survival (OS) analysis demonstrated Herceptin plus chemotherapy improved overall survival by 37 percent compared to chemotherapy alone (based on HR=0.73, 95 percent CI 0.60-0.91, p=0.0038, median OS 13.5 vs. 11.0 months). An updated OS analysis based on an additional year of follow up showed a 25 percent improvement in OS (based on HR=0.80, 95 percent CI 0.67-0.97, p=0.02; median OS 13.1 vs. 11.7 months).

Patients with tumors exhibiting high levels of HER2 (IHC3+ or IHC2+/FISH-positive, 16% of patients tested for HER2 in the ToGA study) experienced even greater benefit from the addition of Herceptin. For these patients, overall survival in the study was 16 months on average versus 11.8 months for patients receiving chemotherapy alone. The EU label recommends Herceptin for patients expressing high levels of HER2.

In ToGA, the safety profile of Herceptin was consistent with previous studies in HER2-positive breast cancer, and no new or unexpected adverse events were seen in the Herceptin plus chemotherapy group (one person in the Herceptin group and two people in the comparison group experienced heart failure).

All patients in this trial had their tumors tested for HER2 status using two companion diagnostics. Based on HER2 screening results (using both HER2 IHC and FISH diagnostic tests) in ToGA, approximately 22 percent of patients with metastatic stomach cancer have HER2-positive tumors. A positive result for HER2 overexpression with either test was required for study entry.

About Stomach Cancer
Stomach cancer is the second most common cause of cancer-related death in the world and is the fourth most commonly diagnosed cancer, with over 1,000,000 cases of stomach cancer diagnosed each year(1). Metastatic stomach cancer is associated with a poor prognosis; the median survival time after diagnosis is approximately 10-11 months with currently available therapies(2). Early diagnosis of this disease is challenging because most patients do not show symptoms in the early stage.

About Herceptin
Herceptin is a humanized antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. The mode of action of Herceptin is unique in that it activates the body’s immune system and suppresses HER2 to target and destroy the tumor. Herceptin has demonstrated unprecedented efficacy in treating both early and metastatic HER2-positive breast cancer. Given on its own as monotherapy as well as in combination with or following standard chemotherapy, Herceptin has been shown to improve response rates, disease-free survival and overall survival while maintaining quality of life in women with HER2-positive breast cancer.

Herceptin is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche.

Since 1998, Herceptin has been used to treat more than 750,000 patients with HER2-positive breast cancer worldwide.

Roche Personalised Healthcare: Fitting treatments to patients
Different people respond differently to medicines. The aim of Roche Personalised Healthcare (PHC) is to target treatments to the patients most likely to benefit. This means tailoring treatments to specific patient sub-groups who share similar characteristics in their genetic makeup or in the molecular nature of their disease. This approach has enormous potential to make healthcare better, safer and more effective, with benefits for patients, physicians, payers, and society at large.

Herceptin treatment in breast cancer is a case in point: Measuring the levels of the protein HER2 in breast cancer cells with specific tests such as the assays from Roche Tissue Diagnostics (Ventana) reliably identifies patients who are likely to respond to Herceptin, a medicine that specifically targets HER2. Roche is also applying this approach to the diagnosis and the treatment of HER2-positive metastatic gastric cancer with Herceptin.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80'000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

1) American Cancer Society. Global Cancer Facts & Figures 2007.
2) Ohtsu A. J Gastroenterol 2008;43:256-264.

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