Roche Holdings Ltd.
) recently announced results from its phase III study (EMILIA
study) of trastuzumab emtansine (T-DM1). The study showed that
trastuzumab emtansine significantly improved overall survival (OS)
in people suffering from HER2-positive metastatic breast cancer
(mBC) in comparison to the combination of
) lapatinib and Xeloda (capecitabine).
The EMILIA study is evaluating trastuzumab emtansine in patients
suffering from HER2-positive mBC and who previously had Herceptina
(for the treatment of HER2-positive breast cancer) along with
taxane chemotherapy. The study has now met both the co-primary
endpoints of improvement in OS and progression-free survival (PFS).
Roche now plans to offer patients in the lapatinib and Xeloda arm
of EMILIA, the option to receive trastuzumab emtansine.
Notably, in June this year, Roche had announced that the EMILIA
study met its first co-primary endpoint of PFS. The study revealed
that patients receiving trastuzumab emtansine showed 35% lower risk
in disease worsening or death than those who received lapatinib and
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). Roche also plans to submit a marketing
authorization application for trastuzumab emtansine to the European
Medicines Agency (EMA) soon.
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. The data demonstrated that the
candidate reduced the size of tumors in one-third of patients with
advanced HER2-positive breast cancer.
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 mBC.
Roche had then decided to continue with its EMILIA study to support
the re-submission of the BLA.
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