) recently announced positive results on Afinitor, from a phase
III trial, BOLERO-3 (Breast cancer trials of OraL
The study evaluated Novartis' Afinitor plus
) Herceptin and vinorelbine for the treatment of women suffering
from human epidermal growth factor receptor-2 positive (HER2+)
advanced breast cancer.
The study showed that Afinitor plus Herceptin and vinorelbine
significantly extended progression-free survival (PFS) among
treatment-experienced women vis-à-vis placebo plus Herceptin and
vinorelbine, and reduced the risk of disease progression by
The study met its primary endpoint while data on secondary
endpoint (overall survival) is not yet mature. We note that
Novartis had presented initial results from the BOLERO-3 study in
Novartis now plans to submit data from the trial to regulatory
authorities across the world. We note that Afinitor is already
approved in the US and EU for the treatment of HR+/HER2- advanced
breast cancer in combination with
) Aromasin, in postmenopausal women, whose disease has returned
or progressed even after undergoing treatment with a
non-steroidal aromatase inhibitor.
Novartis estimates that approximately 140,000 women are
suffering from HER2+ advanced breast cancer across the world.
Hence, the successful development and commercialization of
Afinitor for the above-mentioned indication will further boost
the sales potential of the drug. Afinitor generated sales of $797
million in 2012, up 85% year over year.
However, we note that Roche has a pretty strong position in
the breast cancer market. Roche obtained EU approval for Perjeta
in Mar 2013, as a combination therapy for the treatment of adults
with previously untreated HER2+ metastatic breast cancer
In 2012, Roche obtained US Food and Drug Administration (FDA)
approval for Perjeta plus Herceptin and docetaxel chemotherapy
for treating patients suffering from HER2+ mBC.
Additionally, in Feb 2013, Roche obtained FDA approval for
Kadcyla for the treatment of patients suffering from HER2+
We believe the recent approvals of Perjeta and Kadcyla in
addition to the existing drug Herceptin has strengthened Roche's
HER2+ mBC franchise considerably.
Novartis currently carries a Zacks Rank #3 (Hold). Right now,
) looks attractive with a Zacks Rank #1 (Strong Buy).
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