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UPDATE 1-Failed Avastin early-stage cancer study detailed

Sat May 30, 2009 9:00pm IST
 
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 * 77.4 pct of Avastin patients disease free vs 75.5 pct
 * 40 pct reduction in recurrence at one year
 * Results of second "adjuvant" trial expected next year
(Adds company comments, researcher comments, byline)
 By Deena Beasley
 ORLANDO, Fla., May 30 (Reuters) - A study of blockbuster
drug Avastin in colon cancer patients who have undergone
surgery showed that the drug's effectiveness wore off after
patients stopped taking it, researchers said on Saturday.
 As previously disclosed by the drug's maker, Roche Holding
AG's (ROG.VX: Quote, Profile, Research) Genentech unit, the 2,710-patient trial did not
meet its main goal of showing an extension in disease-free
survival.
 Newly released details show that 77.4 percent of patients
in the Avastin group were alive and free of disease after a
median follow-up of three years, compared with 75.5 percent of
patients in the control group, a difference that was not
statistically significant.
 But at the one-year mark, Avastin was shown to reduce the
risk of cancer recurrence or death by about 40 percent. 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 said. "The one-year duration of treatment was
insufficient to derive clinical benefit."
 This was the first trial which sought to show Avastin's
ability to prevent cancer recurrence by wiping out microscopic
cancer cells that may remain in the body after tumors have been
removed by surgery, known as use in the "adjuvant" setting. But
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.
 Bishop said the latest findings, presented here at a
meeting of the American Society of Clinical Oncology, are
influencing Roche/Genentech's ongoing clinical trial program
for Avastin.
 The drug, known chemically as bevacizumab, is an antibody
designed to fight cancer by interfering with the blood supply
to tumors. A month of Avastin treatment costs about $4,400.
 The drug, which has annual sales of about $4.4 billion, 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.
 "There was a transient benefit in disease-free survival
during the one year that bevacizumab was given," said Dr Norman
Wolmark, chairman of the Department of Human Oncology at
Allegheny General Hospital and the study's lead author.
 The trial was conducted by the National Surgical Adjuvant
Breast and Bowel Project group and was funded by the National
Cancer Institute.
 "We hope to start a trial in the not too distant future
where we use bevacizumab for a period of two years," Wolmark
said.
  (Reporting by Deena Beasley, editing by Eric Beech)


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