Basel, 18 December 2009
Herceptin receives positive opinion in record time for the treatment of HER2-positive advanced stomach cancer in Europe
Patients with stomach cancer live longer when treated with Herceptin
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency (EMEA) Committee on Human Medicinal Products (CHMP) has issued a positive recommendation for the use of Herceptin (trastuzumab) in combination with standard chemotherapy for the treatment of patients with HER2-positive metastatic stomach (gastric) cancer (metastatic adenocarcinoma of the stomach or gastro-esophageal junction).
Herceptin has received positive opinion in Europe for this new indication in record time because of the high unmet medical need and the strength of the data of the international ToGA trial. This trial demonstrated that combining Herceptin with chemotherapy (Xeloda or intravenous 5-FU and cisplatin) prolongs the lives of patients with this aggressive cancer. Overall survival for patients with high levels of HER2 receiving Herceptin was 16 months on average versus 11.8 months for patients receiving chemotherapy alone.i
“We are delighted by the positive opinion granted by the CHMP. Patients with advanced HER2-positive stomach cancer will be getting access to this innovative treatment representing a significant step forward in the management of stomach cancer. The results of the ToGA trial reinforce the need for accurate testing for HER2 as standard practice for all advanced stomach cancer patients”, said William M. Burns, CEO of Roche’s Pharmaceuticals Division.
Herceptin is already licenced for the treatment of HER2-positive breast cancer and has provided significant benefit to many thousands of women worldwide. Pending approval by the European Commission, patients with HER2-positive stomach cancer will soon be able to benefit from Herceptin treatment. Approximately 16% of patients with stomach cancer have tumours that express high levels of HER2i and these patients will be eligible for Herceptin therapy.
Over one million cases of stomach cancer are diagnosed worldwide each year and stomach cancer is the second most common cause of cancer-related death in the world with around 800,000 people dying each year.ii Early diagnosis is challenging as patients may not experience symptoms until the disease has progressed. Advanced stomach cancer is associated with a poor prognosis; the median survival time after diagnosis is approximately 10-11 months with currently available therapies.iii
ToGA is the first randomised Phase III trial investigating the use of Herceptin in patients with inoperable locally advanced, recurrent and/or metastatic HER2-positive stomach cancer. Approximately 3,800 patients were tested for HER2-positive tumours and 594 patients with HER2-positive disease were enrolled into the study.i The rationale for conducting this trial was based on the knowledge that the targeted therapy Herceptin has demonstrated unprecedented efficacy in the treatment of HER2-positive breast cancer. In addition, the overexpression of HER2 was also observed in stomach cancer. Targeted cancer therapies are drugs or other substances that block the growth and spread of cancer by interfering with specific molecules involved in tumour growth and progression.iv
In the ToGA study, patients were randomised to receive one of the following regimens as their first line of treatment:
- A fluoropyrimidine (Xeloda or intravenous 5-FU) and cisplatin every 3 weeks for 6 cycles. Most patients were receiving Xeloda and cisplatin as chemotherapy
- Herceptin 6mg/kg every 3 weeks until progression in combination with a fluoropyrimidine and cisplatin for 6 cycles
The primary objective of the study was to demonstrate superiority in overall survival of the Herceptin-containing treatment arm compared to the chemotherapy alone arm. The pre-planned interim analysis was triggered by the occurrence of 347 events. Secondary endpoints for the study included progression-free survival, overall response rate, duration of response, safety and quality of life. In the ToGA study, no new or unexpected side effects were observed. For overall survival, the Hazard Ratio was 0.74 (CI 0.60, 0.91) with a highly significant p-value of p=0,0046. Herceptin increased the median overall survival time by 2.7 months to 13.8 months. The response rate was increased with Herceptin from 34.5 % to 47.3%. Patients with tumours exhibiting high levels of HER2 experienced even greater benefit from the addition of Herceptin (overall survival for these patients was 16 months on average versus 11.8 months for patients receiving chemotherapy alone).i
Herceptin is a humanised 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 tumour. Herceptin has demonstrated unprecedented efficacy in treating both early and advanced (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 received approval for use in the European Union for advanced (metastatic) HER2-positive breast cancer in 2000, and for early HER2-positive breast cancer in 2006. In the advanced setting, Herceptin is now approved for use as a first-line therapy in combination with paclitaxel where anthracyclines are unsuitable, as first-line therapy in combination with docetaxel, and as a single agent in third-line therapy. It is also approved for use in combination with an aromatase inhibitor for the treatment of post-menopausal patients with HER2 and hormone receptor co-positive metastatic breast cancer. In the early setting, Herceptin is approved for use following standard (adjuvant) chemotherapy. Herceptin has received CHMP positive opinion for the treatment of HER2-positive metastatic stomach 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 650,000 patients with HER2-positive breast cancer worldwide.
Xeloda (capecitabine) is a highly effective targeted oral chemotherapy offering patients a survival advantage when taken on its own or in combination with other anticancer drugs. Xeloda uniquely activates the cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells so avoiding damage to healthy cells. Xeloda tablets can be taken by patients in their own home, reducing the number of hospital visits.
Licensed and marketed by Roche in more than 100 countries worldwide, Xeloda has more than ten years of proven clinical experience providing an effective and flexible treatment option to over 1.8 million people with cancer. Xeloda is currently approved in:
- Metastatic Colorectal Cancer
- Metastatic Breast CancerAdjuvant Colon Cancer
- Advanced Gastric Cancer
- Metastatic Pancreatic Cancer
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 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 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.
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i) Van Cutsem et al. Abstract #7BA ECCO/ESMO 2009
ii) American Cancer Society. Global Cancer Facts & Figures 2007
iii) Ohtsu A. J Gastroenterol 2008;43:256-264