This is great news for those women who wait to have mammograms or the mammograms did not show the existing cancer. When breast cancer is found in Stage 4 the prognosis has not been good. So there is hope because of a successful drug trial.
Roche Holding AG
Friday reported positive results from a late-stage study that compared
its experimental breast cancer drug trastuzumab emtansine to a rival
product from GlaxoSmithKline
PLC, paving the way to file the potential blockbuster drug for regulatory approval in Europe and the U.S. later this year.
Basel-based drug maker said women whose breast cancer had spread
despite earlier treatment lived longer without their disease getting
worse when treated with Roche's trastuzumab emtansine, or T-DM1,
compared with those who received Glaxo's Tykerb plus chemotherapy.
The study involved 991 women previously treated with another Roche
drug Herceptin plus chemotherapy, whose cancer spread after this initial
"We believe this suggests that the observed benefit is likely to be a
meaningful one and that at least a trend toward a survival improvement
is likely," Deutsche Bank analysts said in a note to investors. Roche
said data to show if the drug helps prolonging patients life wasn't
T-DM1 is an antibody drug which delivers the chemotherapy agent
directly inside cancer cells, with the aim of causing fewer side
effects. Roche said final results for overall survival aren't yet
Analysts said the trial results, which were expected after a
similarly good outcome of intermediate tests, are a sign that the
company's strategy to improve standard care through innovative drug
discovery is paying off. But they noted that, until the drug proves to
work also as first-line treatment, market potential is limited.
"These results enable Roche to register the drug, but as a
second-line treatment, the market opportunity is limited," said Andrew
Weiss, an analyst in Zurich with Vontobel. "If the second set of data
shows it also works as a first-line treatment, then that will open up
the market," Weiss said, adding the drug carries a sales potential of
1.7 billion Swiss francs ($1.8 billion) if marketed globally. Another
ongoing late-stage study, dubbed MARIANNE, is testing if T-DM1 also
works on patients who weren't previously treated with established drugs.
This trial's results are expected in 2014.
"We have significantly increased confidence that the front-line
trial…will report positively," analysts at Deutsche Bank said, adding
that annual sales could reach more than $1.5 billion if the drug was
approved for this use.
Mr. Weiss, who has a buy rating on Roche, also said that T-DM1
results, coupled with "stellar" data on experimental compound pertuzumab
can help Roche alleviate competitive pressure on its blockbuster breast
cancer drug Herceptin. He said Roche is likely to present detailed
results at the American Society of Clinical Oncology Annual ASCO meeting
Roche is developing T-DM1 with ImmunoGen Inc.
ImmunoGen's Chief Executive Daniel M. Junius said in an interview that
the top-line results from Roche were symbolically significant because
it validated the company's antibody technology.
He also said first-line study data on TDM-1 isn't expected until late
2013 into 2014, but a second-line application is important,
representing the most immediate opportunity to make the drug available
to patients. He said the current second-line treatment has a limited
patient population and hasn't been very successful.