Roche Holdings Ltd.
) recently announced additional results from its phase III EMILIA
study, which was conducted with trastuzumab emtansine. The study
compared trastuzumab emtansine to
) Tykerb (lapatinib) along with Xeloda (capecitabine) in
HER2-positive unresectable locally advanced or metastatic breast
cancer patients who were previously treated with Herceptin and
Results showed that patients who were treated with trastuzumab
emtansine survived longer (risk of death was reduced by 32%) than
those who were treated with the combination of lapatinib and
Xeloda. Median overall survival was higher in the trastuzumab
emtansine arm compared to patients receiving lapatinib and Xeloda
(30.9 months vs. 25.1 months).
Roche now plans to offer patients in the Tykerb and Xeloda arm
the option of being treated with trastuzumab emtansine.
Notably, in June this year, Roche had announced that the EMILIA
study met its co-primary endpoint of progression-free survival
(PFS). The study revealed that patients receiving trastuzumab
emtansine showed 35% lower risk in disease worsening or death than
those who received lapatinib and Xeloda.
Then, in August, the company announced that trastuzumab
emtansine significantly improved overall survival (OS) in patients
suffering from HER2-positive metastatic breast cancer in comparison
to the combination.
Under an agreement with
), Genentech, a member of the Roche Group, licenses technology for
trastuzumab emtansine. Genentech submitted a Biologics License
Application (BLA) for the candidate 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.
We remind investors that Roche had earlier submitted a BLA
seeking accelerated approval for the candidate in July 2010 on the
basis of mid-stage trial results. However, in August 2010, the FDA
had refused the application because it believed that the patients
in the phase II study had not tried all possible medications
available for the treatment of metastatic breast cancer. Roche had
then decided to continue with its EMILIA study to support the
re-submission of the BLA.
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 coming years.
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