) recently presented positive data from three large randomized
phases III studies (ENESTnd, ENESTcmr and LASOR) conducted on its
oncology drug Tasigna.
The studies reinstated the superiority of Tasigna over Glivec
in achieving deeper molecular responses across various patient
populations affected by Philadelphia chromosome-positive chronic
myeloid leukemia (Ph+ CML).
These patient populations included newly-diagnosed patients,
patients with residual disease who switched to Tasigna after
long-term treatment with Glivec, and patients who failed to
respond to frontline Glivec.
The ENESTnd (Evaluating Nilotinib Efficacy and Safety in
Clinical Trials - Newly Diagnosed Patients) compared the efficacy
and safety of Tasigna versus Glivec in adult patients with newly
diagnosed Ph+ CML in chronic phase. The data from the study
indicated a trend for higher overall survival (OS) and event-free
survival (EFS) rates in patients treated with Tasigna compared to
patients treated with Glivec.
Novartis also presented data from the ENESTcmr (Evaluating
Nilotinib Efficacy and Safety in Clinical Trials - Complete
Molecular Response) study, which showed that Ph+ CML patients
with residual disease following long-term treatment with Glivec
achieved deeper molecular responses after switching to
Meanwhile, results from the LASOR (Imatinib Dose Optimization
versus Nilotinib in CML Patients with Suboptimal Response to
Imatinib) study compared the efficacy of Tasigna 400 mg twice
daily to Glivec 600 mg once daily. The study showed higher rates
of molecular response in patients who failed to achieve a
cytogenetic response (CCyR) with frontline Glivec and switched to
Tasigna compared to those whose dose of Glivec was escalated.
We note that Tasigna is approved for the treatment of chronic
phase and accelerated phase Ph+ CML in adult patients, resistant
or intolerant to at least one prior therapy, including
Tasigna was one of the top-selling drugs for Novartis in the
first nine months of 2013, generating sales of $914 million, up
33% from the year-ago period.
Sales of Glivec were down 1% due to loss of patent exclusivity
in Brazil, Russia, Canada, Turkey and Mexico, and increased
competition in the Ph+ CML indication.
We are encouraged by the results of the follow-up study on
Tasigna, which showed its superiority over Glivec in treating Ph+
CML in adult patients and should help replace some of the lost
Novartis currently carries a Zacks Rank #3 (Hold). Some of the
better-ranked stocks which look attractive at current levels
). All three carry a Zacks Rank #2 (Buy).
BAYER A G -ADR (BAYRY): Free Stock Analysis
FURIEX PHARMACT (FURX): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
SHIRE PLC-ADR (SHPG): Free Stock Analysis
To read this article on Zacks.com click here.