Roche Holdings Ltd.
(
RHHBY
), along with the Breast International Group (BIG), recently
announced results from its phase III HERA trial of Herceptin
(trastuzumab). Results from the trial showed that there was no
difference in disease-free survival in women who received Herceptin
for two years in comparison to those who received Herceptin for a
year.
This means that Roche's one-year Herceptin treatment will remain
the standard therapy for patients suffering from early-stage
HER2-positive breast cancer.
The study did not have any new safety findings. Notably, in
2005, interim results from the HERA study were originally reported.
The study met its primary objective of significant benefit in
disease-free survival for women who received Herceptin treatment
for a year versus observation.
The one-year treatment regimen of Herceptin for HER2 positive
breast cancer is approved by global regulatory agencies. In the
first half of 2012, Roche reported Herceptin sales of CHF 2.9
billion.
Meanwhile, Roche is evaluating another candidate, trastuzumab
emtansine, in HER2-positive unresectable locally advanced or
metastatic breast cancer patients who were previously treated with
Herceptin and taxane chemotherapy. The company reported additional
data on trastuzumab emtansine from the phase III EMILIA study,
which compared trastuzumab emtansine to
GlaxoSmithKline
's (
GSK
) Tykerb (lapatinib) plus Xeloda (capecitabine).
A Biologics License Application (BLA) for the candidate has been
submitted to the US Food and Drug Administration (FDA) for use in
women suffering from HER2-positive, unresectable locally advanced
or metastatic breast cancer. Roche also submitted a marketing
authorization application for trastuzumab emtansine to the European
Medicines Agency (EMA) for the same indication.
Our Recommendation
Roche carries a Zacks #1 Rank (Strong Buy rating) in the short
run. We are pleased with the company's progress with its oncology
candidates. We expect several Roche oncology products to hit the
market in the years ahead.
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