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2015-04-27

Novartis International AG: Novartis announces Phase III study of Arzerra® met primary endpoint of improved progression-free survival in patients with relapsed

Novartis International AG / Novartis announces Phase III study of Arzerra® met
primary endpoint of improvedprogression-free survival in patients with
relapsed CLL . Processed and transmitted by NASDAQ OMX Corporate
Solutions.The issuer is solely responsible for the content of this
announcement.
* Positive top-line results seen with Arzerra plus fludarabine and
cyclophosphamide in chronic lymphocytic leukemia (CLL) patients when
initial treatment stopped working
* CLL is the most commonly diagnosed adult leukemia in Western countries,
accounting for approximately 1 in 4 cases of all leukemia[1],[2]
* Most CLL patients experience disease progression despite initial response
to therapy and may require additional treatment[3]

Basel, April 27, 2015
-
Novartis today announced that the top-line results from the Phase III
COMPLEMENT 2 study showed that treatment with Arzerra®(ofatumumab) plus
fludarabine and cyclophosphamide met the primary endpoint of improved
progression-free survival (PFS) in patients with relapsed chronic lymphocytic
leukemia (CLL) (p=0.0036). The safety profile observed in this trial is
consistent with other trials of Arzerra and no new safety signals were
observed.

"Patients eventually stop responding to current CLL treatments, making the
investigation of new options critically important," said Alessandro Riva, MD,
Global Head, Novartis Oncology Development and Medical Affairs. "We're
encouraged by these positive topline results from COMPLEMENT 2, which
demonstrate continued momentum for our expanding oncology portfolio and we
look forward to sharing the full results of this study at an upcoming medical
meeting."

CLL, the most commonly diagnosed adult leukemia in Western countries, accounts
for approximately 1 in 4 cases of leukemia[1],[2].

About COMPLEMENT 2

COMPLEMENT 2 (NCT00824265) is an open-label, two-arm, randomized, Phase III
study, which included 365 patients in 18 countries with relapsed CLL.
Patients in the study were randomized 1:1 to treatment with up to six cycles
of ofatumumab in combination with fludarabine and cyclophosphamide or up to
six cycles with fludarabine and cyclophosphamide alone.

The primary endpoint of the study was PFS was assessed by an Independent
Review Committee (IRC) according to the International Workshop for Chronic
Lymphocytic Leukaemia (iwCLL) updated 2008 National Cancer
Institute-sponsored Working Group (NCIWG) guidelines[4]. Secondary endpoints
included overall response, overall survival, patient reported outcomes, time
to response, duration of response, time to progression, time to next therapy,
safety assessments and quality of life.

Arzerra is not approved for this indication and Novartis will further analyze
the data from the COMPLEMENT 2 study and plans to share the results with
regulatory agencies to evaluate the potential for future regulatory filings.

About Arzerra

Arzerra (ofatumumab) is a human monoclonal antibody that is designed to target
the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL)
cells and normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with
chlorambucil for the treatment of previously untreated patients with CLL for
whom fludarabine-based therapy is considered inappropriate. In the European
Union, Arzerra is approved for use in combination with chlorambucil or
bendamustine for the treatment of patients with CLL who have not received
prior therapy and who are not eligible for fludarabine-based therapy. Arzerra
is also approved for first-line use in Russia, Iceland, Norway, Luxembourg
and Brazil.

In more than 50 countries worldwide, Arzerra is also indicated as monotherapy
for the treatment of patients with CLL who are refractory after prior
treatment with fludarabine and alemtuzumab.

Arzerra is marketed under a co-development and collaboration agreement between
Genmab and Novartis, as successor in interest to GSK.

Important Safety Information for Arzerra (ofatumumab)

Treatment with Arzerra may cause side effects, some of which are serious and
life-threatening.

Treatment with Arzerra may cause a side effect called an infusion reaction,
which may be serious. Before treatment with Arzerra, doctors will prescribe 3
types of medicine to their patients to help reduce the risk of an infusion
reaction including, a steroid (to reduce swelling and other symptoms of
inflammation), a pain reliever, and an antihistamine (to reduce allergic
reactions). Even though patients receive these medicines, they may still have
an infusion reaction. If an infusion reaction occurs, the doctor will stop
their patient's treatment with Arzerra so the infusion reaction can be
treated. Patients should tell their doctor or seek medical treatment right
away if they have any of these symptoms while receiving Arzerra or within 24
hours after receiving Arzerra: fever, chills, rash, hives, chest pain, back
pain, stomach pain, swelling, dizziness, blurred vision, drowsiness,
headache, cough, wheezing, or trouble breathing.

Treatment with Arzerra may cause hepatitis B virus (HBV) infection to reoccur,
which may cause serious liver problems and death. Patients who are newly
exposed to HBV during or following treatment with Arzerra may experience
serious liver problems and death. Patients should tell their doctor if they
have had HBV infection or are a carrier of HBV. Before starting Arzerra,
doctors will do a blood test to check for HBV infection. In some patients,
additional blood tests may be done during and several months after treatment.
Patients should call their doctor right away if they feel more tired than
usual or notice a yellowing of the skin or eyes. These may be symptoms of
hepatitis.

Progressive multifocal leukoencephalopathy (PML) is a rare brain infection
that can occur with treatment with Arzerra. PML causes severe disability and
can lead to death. Patients should call their doctor right away if they
notice new medical problems or problems that are getting worse, such as
confusion, dizziness or loss of balance, difficulty talking or walking, or
strength, vision or other problems that have lasted over several days.

Tumor lysis syndrome (TLS), including the need for a hospital stay, can occur
with treatment with Arzerra. TLS is caused by the fast breakdown of cancer
cells, which then release their contents into the blood. This may lead to
serious problems, including kidney failure or an abnormal heartbeat. Doctors
may do a blood test to check their patients for TLS and may give medicines
before starting treatment with Arzerra to help prevent TLS.

Arzerra can cause low blood cell counts (white blood cells, platelets, and red
blood cells). These low blood cell counts can be severe and, in some cases,
lead to death. Low white blood cells counts (neutropenia), can happen during
treatment. Neutropenia can occur 42 days or longer after the end of treatment
with Arzerra and may also last between 24 and 42 days after the last
treatment dose. Doctors should regularly check their patient's blood to see
if they have low blood cell counts. Patients should call their doctor right
away if they have any bleeding, bruising, red or purple spots on their skin,
paleness, worsening weakness, tiredness, cough that will not go away, fever,
chills, congestion, or any flu-like symptoms while receiving Arzerra.

After a patient receives Arzerra, they should not receive live vaccines until
the doctor who prescribed Arzerra has told them that they may do so.

The most common side effects with Arzerra include infusion reactions, feeling
tired, low white blood cell count, shortness of breath, pneumonia, rash,
fever, nausea, cough, bronchitis, diarrhea, upper respiratory tract infection
and low red blood cell count.

Treatment with Arzerra can increase patients' chances for getting infections.
Some infections, such as pneumonia, bronchitis, and sepsis (a blood
infection), can be serious, and in some cases, life-threatening. Patients
should call their doctor right away if they have a cough that will not go
away, fever, chills, congestion, or any flu-like symptoms while receiving
Arzerra. These symptoms may be signs of a serious infection.

Please see full Prescribing Information, including Boxed WARNING, for Arzerra
(ofatumumab).

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "may," "investigation," "encouraged," "momentum,"
"look forward," "upcoming," "will," "potential," or similar terms, or by
express or implied discussions regarding potential new indications or
labeling for Arzerra, or regarding potential future revenues from Arzerra.
You should not place undue reliance on these statements. Such forward-looking
statements are based on the current beliefs and expectations of management
regarding future events, and are subject to significant known and unknown
risks and uncertainties. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual results
may vary materially from those set forth in the forward-looking statements.
There can be no guarantee that Arzerra will be submitted or approved for any
additional indications or labeling in any market, or at any particular time.
Nor can there be any guarantee that Arzerra will be commercially successful
in the future. In particular, management's expectations regarding Arzerra
could be affected by, among other things, the uncertainties inherent in
research and development, including unexpected clinical trial results and
additional analysis of existing clinical data; unexpected regulatory actions
or delays or government regulation generally; the company's ability to obtain
or maintain proprietary intellectual property protection; general economic
and industry conditions; global trends toward health care cost containment,
including ongoing pricing pressures; unexpected manufacturing issues, and
other risks and factors referred to in Novartis AG's current Form 20-F on
file with the US Securities and Exchange Commission. 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 innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland,
Novartis offers a diversified portfolio to best meet these needs: innovative
medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the
only global company with leading positions in these areas. In 2014, the Group
achieved net sales of USD 58.0 billion, while R&D throughout the Group
amounted to approximately USD 9.9 billion (USD 9.6 billion exclu...

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