Investor Update

Basel, 26 January 2012

Avastin-based regimen extends survival when continued beyond initial treatment in patients with metastatic colorectal cancer

First randomised phase III trial evaluating continued use of Avastin with chemotherapy after disease progression meets primary endpoint

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a phase III study (ML 18147) in metastatic colorectal cancer met its primary endpoint of overall survival. People who received Avastin® (bevacizumab) plus standard chemotherapy as initial treatment (so-called “first-line” treatment) for their metastatic colorectal cancer and then continued on Avastin with a different chemotherapy after their cancer progressed (so-called “second-line” treatment) lived significantly longer than people who received only chemotherapy in the second-line setting.

No new safety findings were observed and adverse events were consistent with those seen in previous trials of Avastin. Full data from the ML 18147 study will be submitted for presentation at an upcoming medical meeting.

"Avastin is already a recognised standard of care which can help people with metastatic colorectal cancer live longer when given in combination with chemotherapy in the first or second-line setting,” said Hal Barron M.D., Chief Medical Officer and Head Global Product Development. “We are encouraged by these data as this is the first randomised study which demonstrates improved survival in people who continue on an Avastin-based regimen after the disease has progressed”.

About the ML 18147 study

ML 18147 is a randomised, open-label phase III intergroup study (AIO/AMG) evaluating the efficacy and safety profile of Avastin plus standard chemotherapy in patients with metastatic colorectal cancer whose disease had worsened following first-line treatment with Avastin plus standard chemotherapy (irinotecan or oxaliplatin-based). Patients were randomised at progression to one of two treatment arms:

  • Arm A: Chemotherapy* plus Avastin (equivalent of 2.5 mg/kg i.v. per week)
  • Arm B: Chemotherapy* alone
    *Depending on the first-line chemotherapy backbone (Fluoropyrimidine / Irinotecan-based or Fluoropyrimidine / Oxaliplatin-based) the chemotherapy backbone was switched in the second-line setting.

The primary endpoint of the study was overall survival measured from the time patients were randomised to the second-line regimen. The secondary efficacy endpoints of the study included progression-free survival, overall response rate and overall survival from the start of first-line therapy.

About Avastin: Over 7 Years of Transforming Cancer Care

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 and kidney cancer, and is also 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 30 other countries for the treatment of patients with glioblastoma (a type of brain cancer). Avastin is also approved in Japan for the treatment of inoperable or recurrent 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 (including colorectal, breast, non-small cell lung, brain, gastric, ovarian and others) and different settings (advanced or early stage disease).

About Avastin: Mode of Action

Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is the key driver of tumour angiogenesis – a fundamental process required for a tumour 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 tumour growth and extend survival with only a limited impact on the side effects of chemotherapy.

About Roche

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.

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