Switzerland-based pharmaceutical company,
Novartis AG
(
NVS
) announced that a positive phase III trial result of Glivec
(imatinib) was published in the
Journal of the American Medical Association (JAMA)
. The phase III trial evaluated Glivec as an adjuvant treatment in
post surgery KIT (CD117)-positive gastrointestinal stromal tumors
(KIT+ GIST) patients. Results from this trial were first presented
at the American Society of Clinical Oncology (
ASCO
) meeting in June 2011.
The trial compared the use of the drug for 3 years versus the
standard 1-year treatment currently approved. Data from the trial
revealed that after five years, 66% of the patients who had taken
Glivec for 3 years after surgery to remove KIT+GIST were free from
cancer recurrence (primary endpoint) versus 48% of those who had
taken the drug for one year.
Moreover, 92% of patients who had taken Glivec for 3 years
showed overall survival (secondary endpoint) versus 82% of those
who had taken the medicine for a year. This is the first
large-scale study demonstrating the survival benefits of prolonged
treatment with Glivec.
GIST is a rare form of tumor in the gastrointestinal tract.
According to the American Cancer Society, approximately 4,000 -
5,000 patients are affected each year in US. The tumors usually
originate in the stomach. The primary treatment option for GIST
that has not spread is surgery.
However, these patients run the risk of recurrence even after
successful and complete surgical removal of the tumor. Glivec thus
provides a treatment option for such patients by improving
recurrence free survival, when the post-surgical duration of Glivec
treatment is extended. Other products currently approved for GIST
includes Sutent by
Pfizer
(
PFE
).
Glivec is currently approved for the treatment of all phases of
Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia
(CML). It is also approved for the treatment of KIT+GIST, which
cannot be surgically removed and/or have already spread to other
parts of the body, and for the treatment of adult patients
following surgical removal of KIT+ GIST.
In February 2012, the Glivec label was updated by European
Commission to include three years of treatment after surgery for
adults with KIT+ GIST.
Our Recommendation
Though we are pleased with Novartis' wide range of products and
its efforts to diversify further, we prefer to remain on the
sidelines in the long term due to the imminent patent cliff faced
by the company. Thus, we have a Neutral recommendation on Novartis.
The company carries a Zacks #4 Rank ("Sell" rating) in the short
run.
NOVARTIS AG-ADR (
NVS
): Free Stock Analysis Report
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PFE
): Free Stock Analysis Report
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