Avastin(R) extends survival in lung cancer study

Main Category: Lung Cancer
Article Date: 15 May 2005 - 8:00 PDT

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A new study, presented for the first time today, reveals that Avastin(R) (bevacizumab rhuMAb-VEGF) significantly extends survival for patients with previously untreated, advanced non-small cell lung cancer (NSCLC)1, the most common form of lung cancer. The data were presented at the 2005 American Society of Clinical Oncology (ASCO) Annual Meeting, Orlando, USA. There are now three cancer types in which Avastin has demonstrated significant clinical benefit - breast, lung and bowel cancer - the three biggest cancer killers in the UK2. Avastin is the only anti-angiogenic agent to report clinical benefit in each of these cancer types.

Lung cancer is the most common cancer worldwide3 with 1.2 million new cases annually; NSCLC accounts for almost 80 percent of all these cases. There are over 38,000 new cases each year in the UK 4. In Britain one person every fifteen minutes is diagnosed with lung cancer5. Lung cancer has a particularly high morbidity and every 30 seconds4 someone in the world dies of the disease.

Avastin is a completely new class of cancer treatment. It starves the cancer of blood and oxygen, which it needs to grow - by targeting and choking the quick-growing blood vessels that feed it. The addition of Avastin to platinum-based chemotherapy (paclitaxel and carboplatin) significantly increased the median overall survival to 12.5 months compared to 10.2 months in patients treated with the standard chemotherapy alone. The study also demonstrated a significant increase in progression-free survival of 6.4 months compared to chemotherapy alone (4.5 months) and a significant increase in response rates (27%).

"Lung cancer is a particularly devastating disease," said Dr Jesme Baird, Director of Patient Care, Roy Castle Lung Cancer Foundation, Glasgow. "For the overwhelming majority, cure is not an option. There is, therefore, a massive need for new and better treatment choices. We therefore welcome this and all advances for the future care of these patients."

About the Trial

The randomised, controlled, multi-centre study sponsored by the National Cancer Institute (NCI) and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG), enrolled 878 patients with advanced NSCLC. Patients were randomised to receive treatment with platinum-based chemotherapy (paclitaxel and carboplatin) with or without Avastin, administered every three weeks for up to six courses. It was reported that the addition of Avastin to chemotherapy was well tolerated.

About Avastin

Avastin is the first treatment that inhibits angiogenesis - the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).

In Europe, Avastin is approved for first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with the chemotherapy regimens of intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan. Avastin received fast-track approval by the US Food and Drug Administration (FDA) and was launched in the US in February 2004.*

In the pivotal Phase III study, the addition of Avastin to chemotherapy (irinotecan/5-fluorouracil/leucovorin) significantly extended survival by, on average, five months (20.3 months versus 15.6 months) for people with previously untreated metastatic bowel cancer.6 In a Phase III study with patients who had previously failed one chemotherapy regimen for their advanced disease, Avastin was also shown to significantly improve survival, by an average of approximately two months (12.5 months vs. 10.7 months), when added to a widely prescribed oxaliplatin-containing chemotherapy regimen (oxaliplatin/5-fluorouracil/leucovorin).7

People with very advanced bowel cancer who are too unwell to tolerate traditional aggressive chemotherapy also benefit from Avastin. The addition of Avastin to a less aggressive form of chemotherapy increased the length of time the cancer was not growing, by four months, compared to chemotherapy alone (a 67 percent increase in progression-free survival).8

A Phase III trial with Avastin in patients with metastatic breast cancer has shown that adding Avastin to first-line paclitaxel chemotherapy resulted in a significant improvement in progression-free survival compared to chemotherapy alone.9

Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in advanced bowel cancer with other chemotherapies and also expanding into the adjuvant setting (post operation). As its mechanism may be relevant in a number of malignant tumours, Roche and Genentech are also investigating the potential clinical benefit of Avastin in pancreatic cancer, ovarian cancer, renal cell carcinoma and others. Approximately 15,000 patients are expected to be enrolled into clinical trials over the next years worldwide.

About Roche in the UK

Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. Find out more at http://www.rocheuk.com

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

For further information, please contact:
Elizabeth Park
Resolute Communications
Tel (switchboard): 0207 357 8187
Tel (direct): 0207 357 9184 / 07989 988 440
Fax: 0207 357 9553
Email: elizabeth.park@resolutecommunications.com
Greg Page
Roche Products Ltd
Tel: 07739 821088
Email: greg.page@roche.com

All trademarks used or mentioned in this release are legally protected. Please note Avastin is not licensed for use in breast cancer.

* In the US, Avastin is approved for use in combination with intravenous 5-fluorouracil-based chemotherapy, for first-line treatment of patients with metastatic carcinoma of the colon or rectum.

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References:

1 Sandler AB, Gray R, Bhramer J, et al. Randomized phase II/III Trial of paclitaxel (P) plus carboplatin (C) with or without bevacizumab (NSC # 704865) in patients with advanced non-squamous non-small cell lung cancer (NSCLC): An Eastern Cooperative Oncology Group (ECOG) Trial - E4599. ASCO 2005, Abstract LBA4.

2 http://www.cancerresearchuk.org/aboutcancer/statistics/mortality

3 World Health Organisation, World Cancer Report, 2003.

4 http://www.lungcancercoalition.org/cancer_facts.html

5 http://www.ash.org.uk, Smoking and Cancer - factsheet number 4, accessed 10.05.05

6 Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal Cancer. New England Journal of Medicine 2004; 350(23): 2335-2342.

7 Mitchell EP, Alberts SR, Schwartz BJ, et al. High-dose bevacizumab in combination with FOLFOX4 improves survival in patients with previously treated advanced colorectal cancer: Results from the Eastern Cooperative Oncology Group (ECOG) study E3200. ASCO Gastrointestinal 2005 Cancer Symposium, January 2005 (abstract 169a).

8 Kabbinavar FF, Joseph Schulz J, McCleod M, et al. Addition of Bevacizumab to Bolus 5-FU/Leucovorin in First-Line Metastatic Colorectal Cancer: Results of a Randomized Phase II Trial.) J Clin Oncol 23:10.1200/JCO.2005.05.112, 2005.

9 Kathy D Miller et al. E2100 study. Presented at 2005 ASCO Annual Meeting

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