Novartis long-term Phase III data show Ph+ CML patients on Tasigna® achieved significantly deeper molecular response versus

 Novartis long-term Phase III data show Ph+ CML patients on Tasigna® achieved
           significantly deeper molecular response versus Gleevec®

- Both newly diagnosed patients and those switching to Tasigna after long-term
treatment with Gleevec achieved deeper molecular response with Tasigna

- Data suggest correlation between early molecular response at three and six
months and survival outcome for newly diagnosed patients

- Novartis reinforces commitment to CML with new clinical trials exploring
treatment free remission in patients who achieve sustained deep molecular
response

PR Newswire

EAST HANOVER, N.J., Dec. 10, 2012

EAST HANOVER, N.J., Dec. 10, 2012 /PRNewswire/ --The latest results from two
Phase III clinical trials further establish the benefits of Tasigna^®
(nilotinib) compared to Gleevec^® (imatinib mesylate) tablets* in the
treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+
CML) in newly diagnosed patients and in those with residual disease who
switched to Tasigna after long-term treatment with Gleevec.

Findings from both studies were presented in oral sessions at the 54^th annual
meeting of the American Society of Hematology (ASH) in Atlanta.

Two-year results from ENESTcmr showed that switching to Tasigna led to deeper
molecular responses** in patients who still had evidence of residual disease
after long-term therapy with Gleevec^1. More than twice as many patients
treated with Tasigna continued to achieve undetectable BCR-ABL versus Gleevec.
The difference between groups by 24 months was statistically significant
(22.1% vs. 8.7%; p=0.0087) and that difference has doubled since the 12-month
analysis. Significantly more patients treated with Tasigna achieved MR4.5 or
undetectable BCR-ABL versus Gleevec regardless of the BCR-ABL transcript level
at baseline^1. In studies published to date, no patients achieving and
maintaining MR4.5 have progressed to advanced stages of CML^2,3,4,5,6.

"Tasigna should be considered as a leading option for frontline therapy
because it allows many patients to achieve deeper responses earlier, which we
have associated with improved long-term outcomes," said Timothy P. Hughes, MD,
ENEST study investigator, Head of the Department of Haematology at Royal
Adelaide Hospital and Clinical Professor at the University of Adelaide,
Australia.

Also presented at ASH are the results of a four-year landmark analysis from
ENESTnd which showed that more than three times as many patients achieved
early molecular response (reduction in BCR-ABL transcript levels to less than
or equal to 10% at months three and six) with Tasigna as frontline therapy
instead of Gleevec^7. The investigators correlated early molecular response
with future major molecular response (MMR) and MR4.5, as well as an increased
probability of progression-free survival and overall survival^7.

In a separate four-year analysis of efficacy and safety data from ENESTnd also
presented at ASH, the difference in the rates of both MR4 and MR4.5 continued
to be significantly higher for Tasigna, with the difference in favor of
Tasigna increasing over time (MR4: 9-14% difference by one year, 17-24%
difference by four years; MR4.5: 6-10% difference by one year, 14-17%
difference by four years)^7. Overall survival remained similar in all groups
at four years, but fewer CML-related deaths occurred in both the Tasigna 300
mg twice daily (n=5) and 400 mg twice daily (n=4) arms versus Gleevec
(n=13)^7.

"We are encouraged by the continued strong findings from newly-presented CML
data at ASH," said Herve Hoppenot, President, Novartis Oncology. "Our
dedication to ongoing research in CML over the past decades has helped to
transform the disease from a fatal diagnosis to a chronic condition. We are
now starting the next chapter in our commitment to helping patients with this
disease by exploring in Tasigna clinical trials the idea that some patients
may be able to safely stop therapy after achieving sustained and deep
molecular response."

Novartis Commitment to CML
Novartis Oncology helped pioneer the transformation of Ph+ CML to a treatable,
chronic condition. As an industry leader in CML, Novartis is committed to
furthering the understanding of this disease and to redefining once again what
is possible for the future of Ph+ CML. The company plans to initiate in early
2013 a robust clinical trial program evaluating the possibility of
treatment-free remission in CML, which means sustaining deep molecular
response after stopping therapy. Nine treatment-free studies are planned to be
conducted in study centers across more than 50 countries.

Worldwide, CML is responsible for a little over 10% of all adult cases of
leukemia, with an incidence of one to two cases per 100,000 people per
year^8,9.

ENESTcmr study details
ENESTcmr (Evaluating Nilotinib Efficacy and Safety in Clinical Trials –
Complete Molecular Response) is an open-label, randomized, prospective,
multi-center Phase III study of Tasigna 400 mg twice daily versus
standard-dose Gleevec (400 mg or 600 mg once daily) comparing kinetics of
molecular response for patients with Ph+ CML in chronic phase who had achieved
complete cytogenetic response (CCyR) but were still BCR-ABL positive (i.e.,
had evidence of residual leukemia) after at least two years of treatment with
Gleevec. The study enrolled 207 patients. The patients were randomized into
one of two treatment arms: Tasigna 400 mg twice daily versus continuing
Gleevec 400 mg or 600 mg once daily (same dose as at study entry)^1.

The primary endpoint was the rate of confirmed best complete molecular
response by 12 months of study therapy with Tasigna or Gleevec. Secondary
objectives included the kinetics of molecular response, duration of molecular
response, progression-free survival and overall survival in both arms. These
data, presented at ASH, were the 24-month follow-up^1.

More than twice as many patients treated with Tasigna continued to achieve
undetectable BCR-ABL versus Gleevec. The difference between groups by 24
months was statistically significant (22.1% vs. 8.7%; p=0.0087). Compared to
the 12-month analysis, the difference between the treatment arms doubled over
time from 6.7% to 13.4%. Among patients without documented MR4.5 at baseline,
cumulative incidence of MR4.5 was over twice as high in Tasigna-treated
patients versus those who stayed on Gleevec (42.9% vs. 20.8%; p=0.0006) and
the difference increased over time from 12 to 24 months. Significantly more
patients treated with Tasigna achieved MR4.5 versus Gleevec regardless of the
BCR-ABL transcript level at baseline. In patients without documented MMR, MR4
and MR4.5 at baseline, the differences were superior in all subsets (29.2% vs.
3.6%; p=0.016; 31.1% vs. 11.5%; p=0.003 and 42.9% vs. 20.8%; p=0.0006,
respectively)^1.

ENESTnd study details
ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials – Newly
Diagnosed Patients) is a Phase III randomized, open-label, multicenter trial
comparing the efficacy and safety of Tasigna versus Gleevec in adult patients
with newly diagnosed Ph+ CML in chronic phase. It is the largest global
randomized comparison of two oral therapies ever conducted in newly diagnosed
Ph+ CML patients^7,10,11.

The study is being conducted at 217 global sites with 846 patients enrolled.
Patients were randomized to receive Tasigna 300 mg twice daily (n=282),
Tasigna 400 mg twice daily (n=281) or Gleevec 400 mg once daily (n=283). The
primary endpoint was major molecular response (MMR) at 12 months; the key
secondary endpoint was durable MMR at 24 months (patients having MMR when
evaluated at both 12 and 24 months). MMR was defined in this study as 0.1% or
less of BCR-ABL as measured by RQ-PCR. Planned follow-up is for five years.
Patients on the Gleevec treatment arm who had suboptimal response or treatment
failure were allowed to escalate dose and/or switch to Tasigna in a separate
extension study. These data, presented at ASH, were the 48-month minimum
follow-up^7,10,11.

The ENESTnd landmark analysis was based on BCR-ABL transcript levels at three
and six months using data with a minimum follow-up of four years. The Tasigna
300 mg BID (n=282) and Gleevec 400 mg QD (n=283) treatment arms were used for
the analysis. Rates of MMR, MR4.5, progression-free survival and overall
survival were evaluated among patients grouped according to their BCR-ABL
transcript levels of less than or equal to 1%, >1% to less than or equal to
10%, and >10% at three and six months. Among evaluable patients at three
months, 9% of patients (n=24) in the Tasigna arm versus 33% (n=88) in the
Gleevec arm had BCR-ABL transcript levels of >10%. Patients with a BCR-ABL
transcript level of >10% had a significantly lower probability of future MMR
or MR4.5 ^ as well as poorer progression-free survival and overall survival
compared with patients who had BCR-ABL transcript levels less than or equal to
10% at three months. Fewer patients in the Tasigna arm versus the Gleevec arm
had BCR-ABL transcript levels >10% at three and six months. Early molecular
response at three and six months correlated with future MMR and MR4.5 ^ as
well as an increased probability of progression-free survival and overall
survival^7.

The four-year ENESTnd update found continued significantly higher rates of
MMR, MR4 and MR4.5 ^ by three years were achieved in Tasigna versus
Gleevec-treated patients. The difference in the rates of both MR4 and MR4.5 ^
continued to be significantly higher for Tasigna, with the difference in favor
of Tasigna increasing from year one to year four (MR4: 9-14% difference by one
year, 17-24% difference by four years; MR4.5: 6-10% difference by one year,
14-17% difference by four years). Among patients who achieved MMR, more
patients achieved MR4 or MR4.5 ^ on Tasigna 300 mg twice daily (68%) and
Tasigna 400 mg twice daily (62%) compared with Gleevec (49%). No patient in
any arm progressed after achieving MR4.5. Significantly fewer patients
progressed to accelerated phase/blast crisis on Tasigna versus Gleevec. Nearly
twice as many patients had emergent mutations on Gleevec (n=21) versus either
Tasigna arm (n=11 in each arm), with five patients overall developing
mutations between two and three years. Overall survival remained similar in
all groups at three years, but fewer CML-related deaths occurred in both the
Tasigna 300 mg twice daily (n=5) and 400 mg twice daily (n=4) arms versus
Gleevec (n=14). Both drugs were well tolerated. Few new adverse events (AEs)
and laboratory abnormalities were observed between two and three years. Rates
of discontinuation due to AEs were 10%, 14%, and 11% in the Tasigna 300 mg
BID, Tasigna 400 mg BID, and Gleevec arms, respectively^11.

About Tasigna
TASIGNA^® (nilotinib) is approved for the treatment of adult patients with
newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+
CML) in chronic phase. The effectiveness of TASIGNA for this indication is
based on major molecular response and cytogenetic response rates at 12 months.
The study is ongoing and further data will be required to determine long-term
outcome.

TASIGNA is also approved in more than 90 countries for the treatment of
chronic phase and accelerated phase Ph+ CML in adult patients resistant or
intolerant to at least one prior therapy, including Gleevec. The effectiveness
of TASIGNA for this indication is based on hematologic and cytogenetic
response rates.

BOXED WARNING and Important Safety Information for TASIGNA (nilotinib):

WARNING: QT PROLONGATION AND SUDDEN DEATHS

TASIGNA prolongs the QT interval. Prior to TASIGNA administration and
periodically, monitor for hypokalemia or hypomagnesemia and correct
deficiencies. Obtain ECGs to monitor the QTc at baseline, seven days after
initiation, and periodically thereafter, and follow any dose adjustments.

Sudden deaths have been reported in patients receiving nilotinib. Do not
administer TASIGNA to patients with hypokalemia, hypomagnesemia, or long QT
syndrome.

Avoid use of concomitant drugs known to prolong the QT interval and strong
CYP3A4 inhibitors.

Patients should avoid food 2 hours before and 1 hour after taking dose.

Treatment with TASIGNA can cause Grade 3/4 thrombocytopenia, neutropenia, and
anemia. Complete blood counts should be performed every 2 weeks for the first
2 months and then monthly thereafter.

Caution is recommended in patients with a history of pancreatitis.

The use of TASIGNA may result in elevations in bilirubin, AST/ALT, and
alkaline phosphatase.

TASIGNA can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia,
and hyponatremia (see Boxed WARNING).

The concomitant use of strong CYP3A4 inhibitors or anti-arrhythmic drugs
(including, but not limited to, amiodarone, disopyramide, procainamide,
quinidine, and sotalol) and other drugs that may prolong the QT interval
(including, but not limited to, chloroquine, clarithromycin, haloperidol,
methadone, moxifloxacin, and pimozide) should be avoided. Grapefruit products
should also be avoided.

The concomitant use of strong CYP3A4 inducers should be avoided (including,
but not limited to, dexamethasone, phenytoin, carbamazepine, rifampin,
rifabutin, rifapentin, phenobarbital, and St. John's wort).

TASIGNA must not be taken with food.

TASIGNA exposure is increased in patients with impaired hepatic function.

Cases of tumor lysis syndrome have been reported in TASIGNA treated patients
with resistant or intolerant CML. Due to potential for tumor lysis syndrome,
maintain adequate hydration and correct uric acid levels prior to initiating
therapy with TASIGNA.

The exposure of TASIGNA is reduced in patients with total gastrectomy.

Since the capsules contain lactose, TASIGNA is not recommended for patients
with rare hereditary problems of galactose intolerance, severe lactase
deficiency with a severe degree of intolerance to lactose-containing products,
or of glucose-galactose malabsorption.

Women of childbearing potential should avoid becoming pregnant while taking
TASIGNA and should be advised of the potential hazard to the fetus if they do.
The safety and effectiveness of TASIGNA in pediatric patients have not been
established.

In newly diagnosed Ph+ CML-chronic phase, the most commonly reported
nonhematologic adverse drug reactions (>10%) were rash, pruritus, headache,
nausea, fatigue, and myalgia.

In resistant or intolerant Ph+ CML-chronic phase, the most commonly reported
nonhematologic adverse drug reactions (greater than or equal to 10%) were
rash, pruritus, nausea, fatigue, headache, constipation, diarrhea, vomiting,
and myalgia.

In resistant or intolerant Ph+ CML-accelerated phase, the most commonly
reported nonhematologic adverse drug reactions (greater than or equal to 10%)
were rash, pruritus, and fatigue.

TASIGNA may need to be temporarily withheld and/or dose reduced for QT
prolongation, hematologic toxicities that are not related to underlying
leukemia, clinically significant moderate or severe nonhematologic toxicities,
laboratory abnormalities, or concomitant use of strong CYP3A4 inhibitors.

Please see full Prescribing Information including Boxed Warning.

About Gleevec
Gleevec^® (imatinib mesylate) tablets are indicated for newly diagnosed adult
patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+
CML) in the chronic phase (CP). Gleevec is also indicated for the treatment of
patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in CP
after failure of interferon-alpha therapy.

GLEEVEC Important Safety Information
GLEEVEC can cause fetal harm when administered to a pregnant woman. Women
should not become pregnant, and should be advised of the potential risk to the
unborn child.

GLEEVEC is often associated with edema (swelling) and serious fluid retention.
Studies have shown that edema (swelling) tended to occur more often among
patients who are 65 and older or those taking higher doses of GLEEVEC.

Cytopenias (reduction or lack of certain cell elements in blood circulation),
such as anemia, have occurred. If the cytopenia is severe, your doctor may
reduce your dose or temporarily stop your treatment with GLEEVEC.

Severe congestive heart failure and left ventricle dysfunction have been
reported, particularly in patients with other health issues and risk factors.
Patients with heart disease or risk factors or history of renal failure will
be monitored and treated for the condition.

Severe liver problems (hepatotoxicity) may occur. Cases of fatal liver failure
and severe liver injury requiring liver transplants have been reported with
both short-term and long-term use of GLEEVEC.

Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in
patients with KIT+ GIST. GI tumor sites may be the cause of this bleeding;
therefore, GI symptoms should be monitored at the start of treatment.

In patients with hypereosinophilic syndrome (a condition with increased
eosinophils, which are a type of white blood cell) and heart involvement,
cases of heart disease (cardiogenic shock/left ventricular dysfunction) have
been associated with the initiation of GLEEVEC therapy.

Skin reactions, such as fluid-filled blisters, have been reported with the use
of GLEEVEC.

Clinical cases of hypothyroidism (reduction in thyroid hormones) have been
reported in patients taking levothyroxine replacement with GLEEVEC.

Long-term use may result in potential liver, kidney, and/or heart toxicities;
immune system suppression may also result from long-term use.

GI perforation (small holes or tears in the walls of the stomach or
intestine), in some cases fatal, has been reported.

Growth retardation has been reported in children taking GLEEVEC. The long-term
effects of extended treatment with GLEEVEC on growth in children are unknown.

Cases of tumor lysis syndrome (TLS), which refers to a metabolic and
electrolyte disturbance caused by the breakdown of tumor cells, have been
reported and can be life-threatening in some cases. Correction of clinically
significant dehydration and treatment of high uric acid levels are recommended
prior to initiation of GLEEVEC.

Reports of motor vehicle accidents have been received in patients receiving
GLEEVEC. Caution patients about driving a car or operating machinery.

Almost all patients treated with GLEEVEC experience side effects at some time.
Some common side effects you may experience are fluid retention, muscle cramps
or pain and bone pain, abdominal pain, loss of appetite, vomiting, diarrhea,
decreased hemoglobin, abnormal bleeding, nausea, fatigue and rash.

GLEEVEC is sometimes associated with stomach or intestinal irritation. GLEEVEC
should be taken with food and a large glass of water to minimize this problem.
There have been rare reports, including deaths, of stomach or intestinal
perforation (a small hole or tear).

If you are experiencing any of the mentioned side effects, please be sure to
speak with your doctor immediately.

Do not take any other medications without talking to your doctor or pharmacist
first, including Tylenol^® (acetaminophen); herbal products (St. John's wort,
Hypericum perforatum); Coumadin^® (warfarin sodium); rifampin; erythromycin;
metoprolol; ketoconazole; and Dilantin^® (phenytoin). Taking these with
GLEEVEC may affect how they work, or affect how GLEEVEC works.

You should also tell your doctor if you are taking or plan to take iron
supplements. Patients should also avoid grapefruit juice and other foods that
may affect how GLEEVEC works.

Please see full Prescribing Information.

Disclaimer
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About Novartis
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an affiliate of Novartis AG, which provides innovative healthcare solutions
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References

1.Hughes TP, Lipton JH, Spector N et al. Switching to Nilotinib Associated
    with Continued Deeper Molecular Responses in CML-CP Patients with Minimal
    Residual Disease After> to2 Years on Imatinib: ENESTcmr 2-Year Follow-Up
    Results. ASH abstract #694, 2012.
2.Kantarjian HM, Hochhaus A, Saglio G, et al. Nilotinib versus imatinib for
    the treatment of patients with newly diagnosed chronic phase, Philadelphia
    chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up
    of the phase 3 randomised ENESTnd trial. Lancet Oncol. 2011;12(9):841-851.
3.Kantarjian HM, Shah NP, Cortes JE, et al. Dasatinib or imatinib in newly
    diagnosed chronic phase chronic myeloid leukemia: 2-year follow-up from a
    randomized phase 3 trial (DASISION). Blood. 2012;119(5):1123-1129.
4.Discontinuation study of imatinib in adult CP CML patients who have a
    complete molecular response to imatinib. Trial
    identifierNCT01564836.http://www.clinicaltrials.gov. Updated March 27,
    2012. Accessed September 25, 2012.
5.Multicenter trial estimating the persistence of molecular remission in
    chronic myeloid leukemia in long term after stopping imatinib (STIM2).
    Trial identifierNCTO1343173. http://www.clinicaltrials.gov. Updated June
    13, 2012. Accessed September 25, 2012.
6.Shami PJ, Deininger M. Evolving treatment strategies for patiensnewly
    diagnosed with chronic myeloid leukemia: the role of second-generation
    BCR-ABL inhibitors as first-line therapy. Leukemia. 2012;26(2):214-224.
7.Hochhaus A, Hughes TP, Saglio G et al. Outcome of Patients with Chronic
    Myeloid Leukemia in Chronic Phase (CML-CP) Based on Early Molecular
    Response and Factors Associated with Early Response: 4-Year Follow-up Data
    from ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials
    - Newly Diagnosed Patients). ASH abstract #167, 2012.
8.American Cancer Society. Detailed Guide: CML. What are the key statistics
    about CML? (09/07/2012 Revision) Available at:
    http://www.cancer.org/Cancer/Leukemia-ChronicMyeloidCML/DetailedGuide/leukemia-chronic-myeloid-myelogenous-key-statistics.
    Accessed October 2012.
9.Central European Leukemia Study Group. About CML. Available at:
    http://www.cml-info.com/de/healthcare-professionals/about-cml.html.
    Accessed October 2012.
10.A Study of Imatinib Versus Nilotinib in Adult Patients With Newly
    Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous
    Leukemia in Chronic Phase (CML-CP) (ENESTnd). Trial identifier
    NCT00471497. http://www.clinicaltrials.gov. Updated July, 18, 2012.
    Accessed November 20, 2012.
11.Kantarjian HM, Kim DW, Issaragrilsil S et al. ENESTnd 4-Year (y) Update:
    Continued Superiority of Nilotinib vs Imatinib in Patients (pts) with
    Newly Diagnosed Philadelphia Chromosome–Positive (Ph+) Chronic Myeloid
    Leukemia in Chronic Phase (CML-CP). ASH abstract #1676, 2012.

Novartis Media Relations
Julie Masow

Novartis Corporation                   Maureen Byrne

+1 212 830 2465 (direct)               Novartis Oncology

+1 862 579 8456 (mobile)               +1 862 778 1518 (direct)

julie.masow@novartis.com               +1 973 714 0063 (mobile)

                                      maureen.byrne@novartis.com

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*Known as Glivec^® (imatinib) outside the US, Canada and Israel

**In ENESTcmr, molecular response (reduction of BCR-ABL transcripts in the
blood of patients) is measured at four levels, based on an international
standard:

  oMMR (less than or equal to0.1% BCR-ABL)
  oMR4 (less than or equal to0.01% BCR-ABL)
  oMR4.5 (less than or equal to0.0032% BCR-ABL)
  oUndetectable BCR-ABL (no detectable BCR-ABL transcript level with sample
    sensitivity of at least 4.5 log)

SOURCE Novartis
 
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