Swiss pharmaceutical giant
) recently presented data from two phase III studies comparing
Tasigna (nilotinib) with Glivec (imatinib) for the treatment of
Philadelphia chromosome-positive chronic myeloid leukemia (Ph+
CML) in newly diagnosed patients. The patients in the study were
switched to Tasigna after long-term treatment with Glivec.
The company presented these data at the American Society of
Hematology (ASH). Results from the two-year ENESTcmr study showed
that patients who switched to Tasigna achieved a significant
deeper molecular response compared to those who remained under
Glivec treatment. The study also revealed that more than twice as
many patients treated with Tasigna were persistent in achieving
undetectable BCR-ABL compared to Glivec.
Novartis also presented data from a four-year landmark
analysis from ENESTnd on Tasigna. Results from this study showed
that more than thrice as many patients with Tasigna as frontline
therapy achieved early molecular response compared to Glivec.
Novartis also presented efficacy and safety data from a
separate four-year analysis from ENESTnd. The data showed that
molecular response rates of both 4 and 4.5 were higher for
Tasigna. Novartis also reported that overall survival remained
same in all the groups at the end of four years, though a lesser
number of deaths occurred in both the Tasigna dose (300mg and
400mg) compared to Glivec.
We note that Tasigna is already approved as a treatment of
first and second line chronic myeloid leukemia (CML) and Ph+ CML
in adults who are resistant or intolerant to Glivec. Novartis
reported Tasigna sales of $261 million in the third quarter of
2012. In November, the company stated that it is planning
additional clinical trials on Tasigna next year.
Glivec is approved for the treatment of Ph+CML and
gastrointestinal stromal tumors (GIST). Glivec sales in the third
quarter of 2012 were $1.2 billion.
We are encouraged by the company's efforts to strengthen its
position in the Ph+CML and CML area. With additional approvals
and treatment options the company will be able to entrench its
position in this crucial disease area.
Currently, we have a Neutral recommendation on Novartis.
Novartis carries a Zacks #3 Rank (Hold) in the short run. Other
pharma companies like
) carry a Zacks #2 Rank (Buy).
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