Novartis Phase III trial examining EPO906 (patupilone) for patients with advanced ovarian cancer failed to meet primary endpoint
(Thomson Reuters ONE) -
Novartis International AG / Novartis Phase III trial examining EPO906 (patupilone) for patients with advanced ovarian cancer failed to meet primary endpoint processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Basel, May 27, 2010 - Novartis announced today that patupilone (EPO906) did not
show a significant overall survival advantage in a phase III trial of patients
with advanced ovarian cancer, refractory or resistant to platinum-based therapy
The comparator arm in the trial was Doxil®/Caelyx® (pegylated liposomal
doxorubicin).
Investigators involved in the study and regulatory agencies have been notified
of the trial outcome. No new or unexpected serious adverse events in the
patupilone arm were identified in the trial. Novartis does not plan to proceed
with regulatory filings based on these data.
Study details
The Phase III study, conducted in approximately 168 sites in 22 countries, was
an open label, active controlled, parallel group, multicenter trial of 829
patients with epithelial ovarian, primary fallopian or primary peritoneal
cancer, who were randomized to receive patupilone or Doxil®/Caelyx®. Before
enrollment in the trial, patients had received up to a maximum of three prior
chemotherapeutic regimens, of which the first was a taxane/platinum therapy.
Patients were randomly assigned to intravenous patupilone (10 mg/m2) once every
three weeks or Doxil®/Caelyx® (50 mg/m2) once every four weeks and were
evaluated for disease status by Ca-125 and CT scans every eight weeks until
disease progression. The primary endpoint of the trial was overall survival.
Secondary endpoints included progression-free survival, safety and overall
response rate.
About patupilone
Patupilone belongs to a class of microtubule stabilizers called epothilones and
is being evaluated in ongoing trials in multiple tumor types, including
metastatic colorectal cancer, brain metastases in non-small cell lung cancer
(NSCLC) and hormone-refractory prostate cancer (HRPC).
Because it is an investigational compound, the safety and efficacy profile of
patupilone has not yet been established. This investigational compound is
available only through carefully controlled and monitored clinical trials. These
trials are designed to better understand the potential benefits and risks of the
compound. Because of uncertainty of clinical trials, there is no guarantee that
patupilone will ever be commercially available anywhere in the world.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "plan," "is being evaluated," "potential," "will," or
similar expressions, or by express or implied discussions regarding potential
future regulatory submissions or approvals for patupilone or regarding potential
future revenues from patupilone. 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 patupilone to
be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that
patupilone will be submitted or approved for sale in any market. Nor can there
be any guarantee that patupilone will achieve any levels of revenue in the
future. In particular, management's expectations regarding patupilone 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; 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 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Megan Humphrey
Novartis Global Media Relations Novartis Oncology
+41 61 324 7999 (direct) +1 862 778 6724 (direct)
+41 79 593 4202 (mobile) megan.humphrey(at)novartis.com
eric.althoff(at)novartis.com
e-mail:media.relations(at)novartis.com
Novartis Investor Relations
Central phone: +41 61 324 7944
Susanne Schaffert +41 61 324 3769 North America:
Pierre-Michel Bringer +41 61 324 1065 Richard Jarvis +1 212 830 2433
Thomas Hungerbuehler +41 61 324 8425 Jill Pozarek +1 212 830 2445
Isabella Zinck +41 61 324 7188 Edwin Valeriano +1 212 830 2456
e-mail:investor.relations(at)novartis.com e-mail:investor.relations(at)novartis.co
*Doxil® is a registered trademark of Centocor Ortho Biotech Products L.P.
Caelyx® is a registered trademark of Schering Plough
[HUG#1419057]
--- End of Message ---
Novartis International AG
Postfach Basel null
WKN: 904278;ISIN: CH0012005267;
Media release (PDF): http://hugin.info/134323/R/1419057/369244.pdf
Unternehmensinformation / Kurzprofil:
Datum: 27.05.2010 - 07:15 Uhr
Sprache: Deutsch
News-ID 21516
Anzahl Zeichen: 0
contact information:
Town:
Basel
Kategorie:
Business News
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