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Mixed results for Avastin

Roche is downplaying Avastin's loss of effectiveness in colon cancer post surgery while data from the ASCO meeting show that Avastin plus chemotherapy increases survival in Her-2 negative breast cancer

Roche is downplaying the announcement that a study of blockbuster drug Avastin in colon cancer patients after surgery has shown that the drug's effectiveness wore off after patients stopped taking it.

Although the trial of 2,710 patients did not meet its main goal of showing an extension in disease-free survival, Roche Holding AG's Genentech unit contends that it doesn't impact the valuation of its $46.8bn deal to buy the remaining stake of Genentech Inc.

Newly released details show that 77.4 per cent of patients in the Avastin group were alive and free of disease after a median follow-up of three years, compared with 75.5 per cent of patients in the control group –  a difference that was not statistically significant.

However, at the end of one year, Avastin was shown to reduce the risk of cancer recurrence or death by about 40 per cent. “This result proves that the drug is active in early-stage cancer,” said Phillippe Bishop, head of clinical development for Avastin at Genentech.

The trial was designed to show whether use of Avastin plus chemotherapy for six months, followed by six months of Avastin alone, results in more patients being cancer free after three years compared with just treating them with chemotherapy.

"As patients come off treatment, the events come back," Bishop added. "The one-year duration of treatment was insufficient to derive clinical benefit."

This was the first trial that sought to show Avastin's ability to prevent cancer recurrence by wiping out microscopic cancer cells that may remain in the body after tumours have been removed by surgery. Several similar trials are under way, including a second in early-stage colon cancer patients for which results are expected next year.

Since all of the current adjuvant trials of Avastin also have treatment durations of one year, there is little expectation that results will be encouraging.

The drug, which has annual sales of about $4.4bn, is currently approved for treating metastatic colorectal, breast, lung and later-stage brain cancers. Use in earlier-stage cancer patients would drive even more sales.

The trial was conducted by the National Surgical Adjuvant Breast and Bowel Project group and was funded by the National Cancer Institute. The intention is to start a trial in the not too distant future using the drug for a period of two years.

New findings for treatment of HER2-negative breast cancer
Data presented at the American Society of Clinical Oncology (ASCO) 2009 meeting, in Orlando, Florida, show that bevacizumab (Avastin) plus commonly used chemotherapies increases the chance of the patient living without the disease worsening by up to 36 per cent compared to chemotherapies alone, in women receiving first-line therapy for advanced HER2-negative breast cancer. The Phase III RIBBON-1 study combined bevacizumab with chemotherapies, including capecitabine (Xeloda), taxanes and anthracyclines and measured progression-free survival (PFS).  No new safety signals for bevacizumab were observed in the study. 

This is the third study (following E2100 and AVADO) to show that bevacizumab can be combined with taxanes for the treatment of advanced breast cancer, and the first to show the benefit of combining bevacizumab with capecitabine or anthracyclines in this group of patients. RIBBON-1 confirms that bevacizumab can be effectively combined with commonly used chemotherapies for first-line treatment of HER- 2 negative metastatic breast cancer, offering patients and physicians more future treatment options. Bevacizumab is not currently licensed for use with anthracyclines or capecitabine and is currently undergoing EMEA review for a licence in combination with docetaxel. It is licensed in combination with paclitaxel for first-line treatment of patients with metastatic breast cancer.

1st June 2009

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