Roche Holding Ltd. : Avastin and pemetrexed combination gives lung cancer patients significantly more time without their disease progressing

Basel, 24  September 2011

New Roche study in non-small cell lung cancer confirms importance of maintenance treatment

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that AVAPERL, a phase III study evaluating the combination of Avastin® (bevacizumab) and chemotherapy for patients with previously untreated, advanced non-squamous non-small cell lung cancer (NSCLC) met its primary endpoint, giving lung cancer patients significantly more time without their disease progressing.  The results will be presented for the first time today at the European Multidisciplinary Cancer Congress in Stockholm.

In AVAPERL, previously untreated NSCLC patients were given four cycles of Avastin, pemetrexed and cisplatin.  Those patients whose disease was controlled (i.e. did not progress) continued treatment with Avastin and pemetrexed and lived for a median of 10.2 months without their disease getting worse (progression-free survival; PFS).  In the control arm, those patients who continued Avastin alone demonstrated a median PFS of 6.6 months (HR=0.50; p>0.001).  No new safety events were observed and adverse events in AVAPERL were consistent with those observed in previous Avastin and pemetrexed clinical trials.

“A period of more than 10 months without disease progression is unprecedented in this group of patients, suggesting that Avastin plus pemetrexed could potentially represent a new Avastin-based approach for people with the most common form of lung cancer" said Hal Barron M.D. Chief Medical Officer and Head, Global Product Development.

Avastin is approved in Europe for the first-line treatment of advanced non-squamous NSCLC in combination with platinum based chemotherapy followed by Avastin as a single agent until disease progression based on a significant survival benefit. AVAPERL is the first phase III study to investigate the combination of Avastin and pemetrexed as maintenance therapy. A recent study of pemetrexed as maintenance treatment (PARAMOUNT) demonstrated a PFS of 6.9 months for pemetrexed alone vs. 5.6m for placebo (HR=0.59, p<0.001).

Full results will be presented today in the Lung Cancer - Early and Metastatic session in Stockholm (13.45, Hall C5).

AVAPERL (MO22089) is a multicentre, randomised, open-label phase III study in 362 patients with previously untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) investigating whether the combination of Avastin and pemetrexed chemotherapy as continuation maintenance therapy further improves the clinical outcomes compared to Avastin alone, in patients who have already received first-line Avastin-cisplatin-pemetrexed induction treatment.  The primary endpoint of the study is progression-free survival (PFS). Secondary endpoints include overall survival, objective response rate, duration of response, quality of life and safety profile.

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 the US and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small cell lung cancer and kidney cancer, and Avastin is also available in the US and over 30 other countries for the treatment of patients with glioblastoma (a type of brain 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 tumor types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian and others) and different settings (advanced or early stage disease).

Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is the key driver of tumor angiogenesis – a fundamental process required for a tumor to grow and to spread (metastasise) to other parts of the body. Avastin’s precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. Avastin helps to control tumor growth and extend survival with only a limited impact on the side effects of chemotherapy.

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.