Roche, the world’s largest biotech company, has reported the results of a large, independent study (GOG240) which showed that the addition of Avastin (bevacizumab) to chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) extended the lives of women with advanced cervical cancer, compared to chemotherapy alone. This study met its primary endpoint of improving overall survival with a statistically significant 29 percent reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone (HR=0.71, p=0.0035).
The study was sponsored by the US National Cancer Institute (NCI) and conducted by the Gynaecologic Oncology Group (GOG),
Women who received Avastin plus chemotherapy lived a median of 3.7 months longer compared to those who received chemotherapy alone; the median overall survival (OS) was 17 months with Avastin plus chemotherapy compared to 13.3 for chemotherapy alone. No new safety signals related to Avastin were observed and overall safety was consistent with that seen in previous pivotal studies of Avastin across different tumour types.
“Worldwide, cervical cancer is the third most common cancer in women, and those who have an advanced form of this cancer need new medicines”, said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We’d like to thank the GOG for their leadership and the NCI for their support of the study. We plan to discuss these encouraging data with regulatory authorities.”
It is estimated that there are more than half a million cases of cervical cancer worldwide each year, with approximately 85 per cent of those in developing countries. Besides effective treatment, it is also critical that more women have access to vaccination against human papilloma virus (HPV; the cause of the vast majority of cervical cancers) and to screening for precancerous lesions. These approaches can prevent women from developing advanced clinical disease.
The GOG240 data was presented at 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) by Dr Krishnansu Sujata Tewari, University of California, Irvine Medical Centre.
Avastin in combination with chemotherapy reduced the risk of death by 29 percent compared to chemotherapy alone (HR=0.71, p=0.0035). Median overall survival was 17.0 months for women who received Avastin plus chemotherapy compared to 13.3 months for chemotherapy alone. Women who received Avastin plus chemotherapy experienced a 33 percent reduction in the risk of disease worsening or death (progression-free survival; PFS) compared to chemotherapy alone (median PFS: 8.2 months vs. 5.9 months; HR=0.67, p<0.002) Avastin plus chemotherapy shrank more tumours (response rate) than chemotherapy alone (48% versus 36%, respectively, p=0.0078). No new safety signals were observed and the overall safety was consistent with that seen in previous pivotal studies of Avastin across tumour types.
GOG240 is an independent, National Cancer Institute (NCI) sponsored phase III trial assessing the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in women with advanced (stage IVb) cervical cancer, or cervical cancer that persisted or recurred after standard treatment. The trial was supported by Roche. The primary endpoint of the study was OS. A total of 452 women in the United States and Spain were randomised to one of four treatment arms: Paclitaxel and cisplatin; Paclitaxel, cisplatin and Avastin (15 mg/kg every three weeks); Paclitaxel and topotecan; Paclitaxel, topotecan and Avastin (15 mg/kg every three weeks).
The Gynaecologic Oncology Group (GOG) is a non-profit international organisation with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The Group is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of their processes is utilised in order to constantly improve the quality of patient care. To promote this mission, the GOG receives support from the National Cancer Institute (NCI) of the National Institutes for Health (NIH).
Cervical cancer is caused when cells of the cervix, the lower part of the uterus, become cancerous. According to the American Cancer Society, cervical cancer can often be found early and sometimes even be prevented entirely if detected early by having regular Pap / smear tests. Almost all cases of cervical cancer (99.7%) are caused by human papilloma viruses (HPV). HPV is a group of more than 150 related viruses, many of which can be easily spread during sexual intercourse.
With the initial approval in the USA for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer. Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer, and is available in the US for the treatment of colorectal cancer, non-small cell lung cancer and kidney cancer. In addition, Avastin is approved in the US and over 60 other countries worldwide for the treatment of patients with progressive glioblastoma following prior therapy. Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer and breast cancer. Avastin is the only anti-angiogenic therapy available for the treatment of these numerous advanced cancer types, which collectively cause over 2.5 million deaths each year.
Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today. Over one million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 500 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.
An independent blood supply is critical for a tumour to grow beyond a certain size (2mm) and spread (metastasise) to other parts of the body. Tumours develop their own blood supply in a process called angiogenesis by releasing vascular endothelial growth factor (VEGF) – a key driver for tumour growth. Avastin is an antibody that precisely targets and inhibits VEGF. Precise VEGF inhibition by Avastin allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments with limited additional impact on the side effects of these therapies.
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