PRESS RELEASE: Roche Holding's Avastin Approved in Europe for First-line Treatment of Patients With Advanced Lung Cancer

Roche Holding's Avastin Approved in Europe for First-line Treatment of Patients With Advanced Lung Cancer

Basel, Switzerland -- First Medicine Shown to Extend Survival Beyond One Year inPreviously Untreated Lung Cancer Patients. Avastin (bevacizumab), Roche's innovative anti-cancer drug, wasapproved today in Europe for the first-line treatment of patientswith advanced non-small cell lung cancer (NSCLC), in combination withplatinum-based chemotherapy.

NSCLC is the most common form of lung cancer, a difficult to treatdisease that kills over 3,000 people per day worldwide.(1) NSCLC isusually diagnosed at an advanced stage, meaning individuals diagnosedwith the disease typically have a life expectancy of only 8 to 10months.(2),(3) Avastin is the only first-line therapy to demonstrateimproved survival benefits beyond one year in patients with advancedNSCLC.

The approval is based on data from the pivotal US phase III trial(E4599) and the 'Avastin in Lung' (AVAiL) phase III trial. Bothstudies demonstrate that Avastin is effective for the treatment ofpatients with NSCLC in combination with platinum-based chemotherapy.The approval is for the use of Avastin at a dose of 7.5 or 15 mg/kg,in combination with platinum-based chemotherapy, for the first-linetreatment of patients with unresectable advanced, metastatic orrecurrent NSCLC other than predominantly squamous cell histology. Thebroad label that Avastin has received for the treatment of NSCLCallows the combination of Avastin with any platinum-basedchemotherapy regimens (for example, together with taxanes orgemcitabine) at the choice of the physician.

Professor Christian Manegold, Professor of Medicine at HeidelbergUniversity, University Medical Center Mannheim, Germany and PrincipalInvestigator of the AVAiL trial, was enthusiastic about the news:"Lung cancer is an extremely difficult disease to treat and Avastinhas proven that it can prolong the life of patients with NSCLC. Atreatment like Avastin that breaks through the one year survivalbarrier is a big step forward. The European approval for Avastinmeans we can reassess our expectations for lung cancer patientsurvival."

Avastin is the first and only anti-angiogenic agent which has beenshown to consistently deliver improved overall and/orprogression-free survival for patients with colorectal, lung, breastand kidney cancer.

About the Phase III studies that formed the basis of the approval

E4599 study

The results of the randomised, controlled, multicentre 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 doseof 15 mg/kg every three weeks plus chemotherapy was 12.3 months,compared to 10.3 months for patients treated with chemotherapy alone.Patients receiving Avastin in combination with paclitaxel andcarboplatin had a 25% improvement in overall survival compared topatients who received chemotherapy alone. Side effects were generallymanageable. Pulmonary haemorrhage/ haemoptysis cases were observed in2.3% of the patients receiving Avastin plus chemotherapy. The mostcommon adverse events associated with Avastin therapy were:hypertension (5.6%), proteinuria (4.2%), fatigue (5.1%) and dyspnoea(5.6%).(4)

AVAiL study

In the double-blind, randomised, controlled, phase III AVAiLstudy, patients received treatment with either Avastin at 7.5mg/kg or15mg/kg + cisplatin/gemcitabine or placebo + cisplatin/gemcitabine.The study involved more than 1,000 patients world-wide withpreviously untreated advanced NSCLC, with histology other thanpredominant squamous cell. The results show that by adding Avastin toa cisplatin/gemcitabine regimen progression-free survival wassignificantly prolonged by 20 to 30% compared with chemotherapyalone. No new or unexpected adverse events were observed.

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Additional information

- Roche in Oncology:

- Roche Health Kiosk, Cancer:

- Avastin:

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(1). Kamangar F, et al. Patterns of cancer incidence, mortality,and prevalence across five continents: defining priorities to reducecancer disparities in different geographic regions of the world. JClin Oncol 2006; 24(14): 2137-50.

(2). Schiller JH, et al. Comparison of four chemotherapy regimensfor advanced non-small-cell lung cancer. N Engl J Med 2002;346:92-8.

(3). Sandler A, et al. Paclitaxel-Carboplatin Alone or withBevacizumab for Non-Small-Cell Lung Cancer. N Engl J Med. 2006:355;2542-50

(4). Data on file. Roche, 2006