2006-12-14

Landmark Study of Avastin in Lung Cancer Published Today in New England Journal of Medicine


Basel, Switzerland (ots/PRNewswire) -

- Avastin is First Medicine to Extend Survival Beyond One Year inPatients With Previously Untreated Non-Small Cell Lung Cancer

Avastin is the first medicine proven to help previously untreatedpatients suffering from the most common form of lung cancer to livelonger than a year, according to a landmark US study (E4599)published today in the prestigious New England Journal of Medicine.

The study showed that the median duration of survival in theAvastin plus paclitaxel and carboplatin chemotherapy group was 12.3months compared to 10.3 months in the group treated with chemotherapyalone. Overall patients treated with Avastin plus chemotherapy had anapproximate 27 percent improvement in survival compared to patientsreceiving chemotherapy alone.

"This is the first large, randomized clinical study in which ananti-angiogenic, combined with chemotherapy, extended survival beyondone year in patients with advanced lung cancer," said Alan B.Sandler, M.D., director of Medical Thoracic Oncology atVanderbilt-Ingram Cancer Center in Nashville, Tenn., and Study Chairfor the E4599 trial. "The results of this study have changed thetreatment standard of care for this devastating disease - animportant step forward for patients with advanced lung cancer."

The results from the pivotal study highlight the outstandingachievements of the innovative cancer medicine Avastin in helpingpeople with previously untreated advanced NSCLC[i]. Lung cancer isthe most common form of cancer as well as the single biggest cancerkiller with more than 900 lives lost to the disease every day inEurope and new treatment options are desperately needed.

The impressive data from the E4599 study formed the basis for theUS approval of Avastin for treatment of advanced NSCLC which wasgranted by the FDA in October 2006. For the European filing[ii] whichwas submitted on 8 August 2006, the E4599 study was supported by thepreliminary data from the ongoing "Avastin in Lung" (BO17704) study.

Avastin was approved in the EU in January 2005 and in the US inFebruary 2004 for the first-line treatment of patients withmetastatic colorectal cancer. It received another approval in the USin June 2006 as a second-line treatment for patients with metastaticcolorectal cancer. The first filing for Avastin in Japan occurred inApril 2006 for the treatment of metastatic colorectal cancer. Morerecently, Avastin was filed for the treatment of women with advancedbreast cancer in the EU in July 2006.

About the pivotal E4599 study

The results of the randomised, controlled, multicenter Phase IIIE4599 study of 878 patients with locally advanced, metastatic orrecurrent NSCLC, with histology other than predominant squamous cell,show that:

- Median survival of patients treated with Avastin at a dose of 15mg/kg every three weeks plus chemotherapy was 12.3 months, comparedto 10.3 months for patients treated with chemotherapy alone

- Patients receiving Avastin at a dose of 15 mg/kg every threeweeks plus paclitaxel and carboplatin had an approximate 27 percentimprovement in overall survival, compared to patients who receivedchemotherapy alone

- Median duration of progression-free survival (measure of thetime patients live without their disease progressing) was 6.2 monthsfor patients treated with Avastin plus chemotherapy, compared to 4.5months for patients treated with chemotherapy alone

- Response rate in patients with measurable disease was more thandoubled to 35 percent in the group receiving Avastin pluschemotherapy, compared to 15 percent in the group receivingchemotherapy alone

- Side effects were generally manageable. Pulmonary haemorrhage(haemoptysis) cases were observed in 1.9% of the patients receivingAvastin plus chemotherapy. The most common adverse events associatedwith Avastin monotherapy were: hypertension (5.6%), proteinuria(4.2%), fatigue (5.1%) and dyspnoea (5.6%)

About Avastin

Avastin is the first treatment that inhibits angiogenesis - thegrowth of a network of blood vessels that supplies nutrients andoxygen to cancerous tissues. Avastin targets a naturally occurringprotein called VEGF (Vascular Endothelial Growth Factor), a keymediator of angiogenesis, thus choking off the blood supply that isessential for the growth of the tumour and its spread throughout thebody (metastasis).

Avastin is the first and only anti-angiogenic agent to havedemonstrated improved overall and/or progression-free survival infour major tumour types, namely: colorectal cancer, non-small celllung cancer, breast cancer and renal cell carcinoma.

Roche and Genentech are pursuing a comprehensive clinicalprogramme investigating the use of Avastin in various tumour types(including colorectal, breast, lung, pancreatic cancer, ovariancancer, renal cell carcinoma and others) and different settings(advanced and adjuvant i.e. post-operation). The total developmentprogramme is expected to include over 40,000 patients worldwide.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As a supplier of innovative productsand services for the early detection, prevention, diagnosis andtreatment of disease, the Group contributes on a broad range offronts to improving people's health and quality of life. Roche is aworld leader in diagnostics, the leading supplier of medicines forcancer and transplantation and a market leader in virology. In 2005sales by the Pharmaceuticals Division totalled 27.3 billion Swissfrancs, and the Diagnostics Division posted sales of 8.2 billionSwiss francs. Roche employs roughly 70,000 people in 150 countriesand has R&D agreements and strategic alliances with numerouspartners, including majority ownership interests in Genentech andChugai. Additional information about the Roche Group is available onthe Internet (www.roche.com).

All trademarks used or mentioned in this release are protected bylaw.

Additional information

- Roche in Oncology:www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

- Roche Health Kiosk, Cancer: www.health-kiosk.ch/start_krebs

- Avastin: www.avastin.com

- For b-roll footage and additional information:www.thenewsmarket.com and search "Avastin"

[i] Sandler A et al. Paclitaxel-Carboplatin Alone or withBevacizumab for Non-Small-Cell Lung Cancer. New England Journal ofMedicine 2006; 355:2542-50

[ii] Locally advanced, metastatic or recurrent non-small cell lungcancer (NSCLC) with histology other than predominant squamous cell

ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de

Contact:For further information please contact: Roche, Dr. Nina Schwab-Hautzinger, Mobile: +41-79-593-43-07, nina.schwab-hautzinger@roche.com

Roche Pharmaceuticals

Zurück zur Übersiche Medizin-Nachrichten

Preisvergleich Medikamente
Medikament oder PZN:   
In Zusammenarbeit mit Medizinfuchs

News

Landmark Study of Avastin in Lung Cancer Published Today in New England Journal of Medicine

Medizin-News