Second Phase III study of Novartis JAK inhibitor INC424 meets primary endpoint in patients with myelofibrosis
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Novartis International AG /
Second Phase III study of Novartis JAK inhibitor INC424 meets primary endpoint
in patients with myelofibrosis
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* COMFORT-II data show INC424 provides marked clinical improvement in patients
with myelofibrosis, measured by reduction in spleen size at 48 weeks
compared to best available therapy
* Myelofibrosis is a debilitating disease with a poor prognosis and limited
available therapies, presenting a critical unmet medical need
* Complete data to be submitted to an upcoming medical meeting
* Two Phase III trials provide basis for worldwide regulatory filings in Q2
2011
Basel, March 15, 2011 - Novartis announced today that a pivotal Phase III trial
of the investigational Janus kinase (JAK) inhibitor INC424 (ruxolitinib) has met
its primary endpoint of significantly reducing spleen size in patients with
myelofibrosis (MF). INC424 is a potent, selective inhibitor of the JAK1 and JAK2
tyrosine kinases.
The European study, called COMFORT-II (COntrolled MyeloFibrosis Study with ORal
JAK Inhibitor Therapy), showed treatment with INC424 provided a statistically
significant reduction in spleen size in patients with primary MF, post-
polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia
myelofibrosis (PET-MF), when compared with best available therapy, administered
at doses and schedules determined by the investigator. The safety profile of
INC424 was consistent with previous studies. Complete study data will be
submitted to an upcoming medical meeting.
These results support findings from another large Phase III clinical trial
(COMFORT-I) conducted by the collaboration partner, Incyte Corporation, in the
US, Canada and Australia comparing treatment with INC424 to placebo in patients
with MF at 24 weeks. In addition, a Phase I/II study published in the September
16, 2010 issue of The New England Journal of Medicine showed that treatment with
INC424 resulted in marked, fast and durable clinical benefits in patients with
MF. These benefits included alleviation of debilitating symptoms and reduction
of spleen size, an accepted measurement of clinical improvement in MF[1],[2].
Results of the COMFORT-II and COMFORT-I clinical trials will form the basis of
worldwide regulatory filings, planned to begin in the second quarter of 2011.
The INC424 investigational studies constitute the largest clinical trial program
in MF to date.
"We are pleased to reach this important milestone in our collaboration to
develop INC424, a compound representing potential progress for patients with
myelofibrosis, a serious malignant disease with limited treatment options," said
Hervé Hoppenot, President, Novartis Oncology. "INC424 illustrates our mission to
turn the promise of innovative, pathway-based compounds into the reality of
therapies for patients with unmet medical needs."
Myelofibrosis is an uncommon, life-threatening blood cancer characterized by
bone marrow failure, enlarged spleen (splenomegaly), debilitating symptoms
including fatigue, night sweats and pruritus, poor quality of life, weight loss
and shortened survival. Myelofibrosis has a poor prognosis and limited treatment
options[1],[3]. Although allogeneic stem cell transplantation may cure MF, the
procedure is associated with significant morbidity and mortality and is usually
appropriate only in younger patients[3]. The five-year survival rate after
transplantation is approximately 50%[4].
Novartis licensed INC424 from Incyte for development and potential
commercialization outside the US. Incyte has retained rights for the development
and potential commercialization of INC424 in the US. Both the European
Commission (EC) and the US Food and Drug Administration (FDA) have granted
INC424 orphan drug status for MF.
Study details
COMFORT-II is a randomized, open-label Phase III study of INC424 versus best
available therapy that enrolled 219 patients with primary MF, PPV-MF or PET-MF
in 56 study locations in Europe. Two-thirds received INC424 and one-third
received best available therapy, administered at doses and schedules determined
by the investigator. The primary endpoint for COMFORT-II is the proportion of
patients achieving a reduction in spleen volume of 35% or more from baseline to
week 48 as measured by MRI (or CT scan in applicable patients). Reduction of
spleen size is an accepted measurement for clinical improvement in MF[1],[2].
COMFORT-II is sponsored by Novartis[5].
About myelofibrosis
Myelofibrosis is a Philadelphia chromosome-negative myeloproliferative
neoplasm[1]. Of the JAK-associated myeloproliferative neoplasms, MF carries the
greatest risk of a poor prognosis, including transformation to fatal acute
myelogenous leukemia. For MF patients in general, clinical findings such as
splenomegaly and constitutional symptoms may be associated with significantly
reduced quality of life[3],[6-8].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "to be submitted," "filings in Q2 2011," "will,"
"planned," "potential," "mission," "promise," or similar expressions, or by
express or implied discussions regarding potential marketing submissions or
approvals for INC424, or the potential timing of such submissions or approvals,
or regarding potential future revenues from INC424. You should not place undue
reliance on these statements. Such forward-looking statements reflect the
current views of management regarding future events, and involve known and
unknown risks, uncertainties and other factors that may cause actual results
with INC424 to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no guarantee
that INC424 will be submitted or approved for sale in any market, or at any
particular time. Nor can there be any guarantee that INC424 will achieve any
particular levels of revenue in the future. In particular, management's
expectations regarding INC424 could be affected by, among other things,
unexpected clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; unexpected regulatory
actions or delays or government regulation generally; the company's ability to
obtain or maintain patent or other proprietary intellectual property protection;
competition in general; government, industry and general public pricing
pressures; the impact that the foregoing factors could have on the values
attributed to the Novartis Group's assets and liabilities as recorded in the
Group's consolidated balance sheet, and other risks and factors referred to in
Novartis AG's current Form 20-F on file with the US Securities and Exchange
Commission. Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected. Novartis is
providing the information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or otherwise.
About Novartis
Novartis provides healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, cost-
saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2010, the Group's continuing operations achieved net sales of
USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding
impairment and amortization charges) was invested in R&D throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 119,000 full-time-equivalent associates (including 16,700 Alcon
associates) and operate in more than 140 countries around the world. For more
information, please visithttp://www.novartis.com.
References
[1] Verstovsek S, Kantarjian H, Mesa RA, et al. Safety and Efficacy of JAK1 &
JAK2 Inhibitor, INCB018424, in Myelofibrosis. New Eng J Med. 2010 September
16;363:1117-1127.
[2] Tefferi A, Barosi G, Mesa RA, et al. International Working Group (IWG)
consensus criteria for treatment response in myelofibrosis with myeloid
metaplasia, for the IWG for Myelofibrosis Research and Treatment (IWG-MRT).
Blood. 2006;108:1497-1503.
[3] The Leukemia & Lymphoma Society. Idiopathic myelofibrosis. 2007. Available
at http://www.leukemia-lymphoma.org/attachments/National/br_1190656475.pdf.
Accessed January 2011.
[4] Tefferi A. Allogeneic hematopoietic cell transplantation versus drugs in
myelofibrosis: the risk-benefit balancing act. Bone Marrow Transplant.
2010;45(3):419-421.
[5] Controlled Myelofibrosis Study With ORal Janus-associated Kinase (JAK)
Inhibitor Treatment-II: The COMFORT-II Trial. Available at
http://clinicaltrials.gov/ct2/show/NCT00934544. Accessed January 2011.
[6] Thiele J, Kvasnicka HM. The 2008 WHO diagnostic criteria for polycythemia
vera, essential thrombocythemia, and primary myelofibrosis. Current Hematol
Malig Reports. 2009;4:33-40.
[7] Tefferi A, Vardiman JW. Classification and diagnosis of myeloproliferative
neoplasms: The 2008 World Health Organization criteria and point-of-care
diagnostic algorithms. Leukemia. 2008;22(1):14-22.
[8] Mesa RA, et al. The Myelofibrosis Symptom Assessment Form (MFSAF): an
evidence-based brief inventory to measure quality of life and symptomatic
response to treatment in myelofibrosis. Leuk Res. 2009;33:1199-1203.
# # #
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Datum: 15.03.2011 - 07:15 Uhr
Sprache: Deutsch
News-ID 52432
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