Roche's majority-owned subsidiary Chugai Pharmaceutical Co. Ltd received approval from the Japanese Health Authority for the use of Herceptin in the early treatment for women with HER2-positive breast cancer. The approval was based on the impressive HERA (HERceptin Adjuvant) study results demonstrating that Herceptin significantly reduced the risk of death and recurrence by more than one third(34 per cent and 36 per cent respectively), in women with HER2-positive early-stage breast cancer when given following surgery and standard chemotherapy. 1
"It is most rewarding to see that Herceptin has improved the outlook for women with HER2-positive breast cancer in such a remarkable way and that its exceptional benefits are being recognised by health authorities across the world", commented William M. Burns, CEO, pharmaceuticals division, Roche. "We hope that all Japanese women suffering from this devastating disease will now be able to have access to Herceptin, a treatment that has been proven to offer the best chance for a cure."
HER2-positive breast cancer affects approximately 20 per cent to 30 per cent2 of women with breast cancer.
Prior to Herceptin, these patients had a particularly poor outlook because of the aggressive nature of their HER2-positive cancer. Based on a meta-analysis of results from randomized studies, it is estimated that Herceptin reduces the number of women who are at risk of their disease coming back within 10 years after diagnosis by about half, from 37 per cent to 18 per cent.3 This means that Herceptin has the potential to change the course of the disease resulting in a much more positive outlook for all women with HER2-positive disease.
Prof. Masakazu Toi, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan commented, "The diagnosis of early HER2-positive breast cancer is no longer seen as a death-sentence as Herceptin reduces the risk of recurrence by about half. It's exciting that Herceptin is considered the standard of care for HER2-positive breast cancer patients around the world".
Evidence that Herceptin benefits patients with HER2-positive breast cancer across all stages of the disease continues to mount, with more than 450,000 patients worldwide treated and a huge clinical study programme ongoing that includes women with early breast cancer, women with advanced (metastatic) breast cancer and women who need further treatment when their disease comes back.
HERA, conducted by the Roche and Breast International Group (BIG) is one of the largest adjuvant studies ever carried out among breast cancer patients; enrolment to the trial began in December 2001, and nearly 5,100 HER2-positive patients were enrolled at 480 sites in 39 countries across the world. HERA is a randomised trial, which, following standard adjuvant systemic chemotherapy and radiotherapy (if applicable), evaluates observation versus Herceptin every three weeks for 12 months or 24 months in women with early-stage HER2-positive breast cancer. The HERA study allowed for the use of a wide range of chemotherapy regimens, and both lymph node-positive and lymph node-negative patients were eligible for entry into the trial.
According to the interim analysis, the primary efficacy endpoint was met, showing that in the 12-month arm, patients who received Herceptin had a statistically significant improvement in disease-free survival (the length of time after treatment during which no disease is found). At a median follow-up of two years, the secondary endpoint of overall survival showed a clear trend towards an improvement, which is to be confirmed as the data analysis proceeds, the company said.
The interim analysis compared Herceptin versus observation and did not include a comparison of 12 months versus 24 months treatment duration. The trial will continue to assess this comparison and data will become available in due time as the study matures.
The HERA study has an external Independent Data Monitoring Committee (IDMC) that regularly reviews safety data. No safety concerns were raised by the IDMC, and the incidence of congestive heart failure was very low (0.5 per cent in the Herceptin arms vs. 0 per cent in the observation arm). Patients in this study will continue to be followed for any side effects.
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. It has demonstrated efficacy in treating both early and advanced (metastatic) 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 is marketed in the United States by Genentech, in Japan by Chugai and internationally by Roche. Since 1998, Herceptin has been used to treat about 450,000 HER2-positive breast cancer patients worldwide.