UPDATE:Roche's Avastin Fails In Early Colon Cancer, Dims Hope
May 30 2009 - 5:07PM
Dow Jones News
The details of a failed study involving Roche Holding AG's
(RHHBY) Avastin showed the drug's effectiveness in preventing
early-stage colon cancer diminished when patients stopped taking
it, a disappointing result.
The data, presented at the annual meeting of the American
Society of Clinical Oncology, were the first results involving
Avastin as a treatment for such early-stage cancer, a potentially
lucrative market. The outcome is seen as a setback for Avastin and
other similar treatments, and bodes poorly for other early-stage
trials of Avastin. The drug, already approved to treat advanced
breast, lung, brain and colorectal cancer, had 2008 U.S. sales of
$2.69 billion.
The study played an important role in the negotiations leading
to Roche's $46.8 billion March buyout of Genentech, which invented
the drug, its flagship product. The trial's failure became public
in April, but no details were given until Saturday.
In a statement, Genentech said that Avastin's early
effectiveness may support its role in helping prevent early-stage
colon cancer from returning and spreading, but that additional
research is needed.
The study, which included 2,710 patients, had a group that
received only six months of standard chemotherapy, and another that
got six months of chemotherapy combined with Avastin along with six
additional months of Avastin.
Although the results ultimately failed, Avastin had a positive
effect in the first year, showing a 40% reduction in the event
rate, but then both study groups quickly reverted to having similar
effectiveness.
"We came very close to reaching early stopping boundaries for
efficacy," said Normal Wolmark, chair of the cooperative group that
ran the trial, at a press conference Saturday. "But once the
[Avastin] was stopped, the benefit disappeared."
The study seems to show that Avastin is stopping cancer from
growing, but isn't eliminating it, physicians said.
The implication of the data is that Avastin should be used
indefinitely in order to delay disease progression, said Leonard
Saltz, of Memorial Sloan-Kettering Cancer Center.
Wolmark said his group hopes to soon begin a similar
post-surgical trial that uses Avastin for a period of two years,
but Saltz wasn't sure that such a trial would yield more insight -
especially since data may not come until 2017.
Physicians also raised concerns that the cost of Avastin, which
Genentech said was about $52,000 a year for patients in this
setting, could make such prolonged, or indefinite, use
prohibitive.
"It gets phenomenally expensive to think of years and years of
therapy," Saltz said. Furthermore, long-term use of Avastin, which
stops cancer growth by blocking the formation of new blood vessels,
may raise safety questions because it isn't clear how the body will
react to the prolonged blocking of this process.
Physicians and investors had high hopes for the study because
its success would provide a new option to patients and add billions
of dollars in new annual sales to Avastin.
Furthermore, the study's failure may shed light on the
effectiveness of drugs similar to Avastin, including Pfizer Inc.'s
(PFE) Sutent as well as Nexavar, sold by Onyx Pharmaceuticals Inc.
(ONXX) and Bayer AG (BAYRY).
The study is a setback for Roche, because usage of Avastin's
early usage remains a key long-term growth driver for the drug, and
there are eight ongoing studies of Avastin in that mode, with the
next data coming at some point in 2010.
The data suggests that those similar Avastin studies are more
likely to fail, a notion that Dr. Wolmark confirmed in expressing a
lack of confidence in the success of those trials.
Prior to the Roche deal, Wall Street's confidence in the study
grew because of the Swiss company's persistence to swiftly close
the Genentech deal, and Genentech's resistance to the takeover
seemed to signal confidence in the study.
Roche has consistently played down the trial's role in the deal,
saying it wanted Genentech for its research and not for the outcome
of the single trial. Despite this assertion, the failure of the
study has raised the question of whether Roche overpaid for
Genentech.
Amit Roy, an analyst that follows Roche for Nomura Securities,
expects that Wall Street will likely come to that conclusion, but
he believes that Roche wasn't solely motivated by Avastin's
potential expansion into earlier stages.
-By Thomas Gryta; Dow Jones Newswires; 201-938-2053;
thomas.gryta@dowjones.com