-
ASSIST-FL trial demonstrates
equivalent safety, efficacy, pharmacokinetics and pharmacodynamics
of Sandoz proposed biosimilar rituximab (GP2013) to the reference
product[1]
-
Interim data in over 600 adults
show potential of GP2013 as an alternative rituximab[1]
-
Sandoz proposed biosimilar
rituximab is the company's first monoclonal antibody
candidate
Holzkirchen, December 5, 2016
- Sandoz, a Novartis division, and the pioneer and global leader in
biosimilars, today announced data from the ASSIST-FL trial. The
confirmatory safety and efficacy study shows GP2013 met its primary
endpoint of overall response rate (ORR), demonstrating equivalence
with the reference product, MabThera®*, in 629
patients. Results were presented at the 58th Annual Meeting of the
American Society of Hematology (ASH).
The combination treatment phase of the ASSIST-FL
study - the first of a three-phase protocol - confirms that, for
patients with previously untreated advanced follicular lymphoma,
the ORR of GP2013 (87.1%) and the reference product (87.5%) were
equivalent. Consistent with clinical practice, patients received
cyclophosphamide, vincristine and prednisone (CVP) in addition to
reference product or GP2013. The final results of the ASSIST-FL
study are expected in 2018 after study completion.
"Sandoz recognizes the access challenges that
healthcare systems are facing, particularly in long-term cancer
care," said Mark Levick, Global Head of Development, Sandoz
Biopharmaceuticals. "If approved, our medicine will offer a
high-quality biologic treatment option that could free up
resources. Not only would this allow for greater investment in new,
innovative treatments, it could also provide more patients with
blood cancers, like follicular lymphoma, access to potentially
life-saving medicine."
The data demonstrated equivalent safety between
Sandoz GP2013 and the reference product, with adverse events being
consistent with those observed in previous clinical trials.
Pharmacokinetics (PK) and pharmacodynamics (PD) were also found to
be equivalent. Secondary endpoints of median progression-free
survival and overall survival are not yet reported as the study is
still blinded and data are evolving.
Sandoz is committed to increasing patient access
to high-quality, life-enhancing biosimilars. It is the pioneer and
global leader in biosimilars and currently markets three
biosimilars worldwide. Sandoz has a leading biosimilar pipeline and
plans to launch five biosimilars of major oncology and immunology
biologics across key geographies by 2020. As a division of the
Novartis Group, Sandoz is well-positioned to lead the biosimilars
industry based on its experience and capabilities in development,
manufacturing and commercialization.
About the ASSIST-FL
study
The study is a prospective, multi-center, randomized, double-blind,
active-controlled, parallel-group, confirmatory Phase III trial
comparing the efficacy, safety, PK and PD of GP2013 plus CVP versus
MabThera® plus CVP. 629
patients were recruited across 159 centers in 26 countries, all
with previously untreated advanced stage follicular lymphoma. The
study is comprised of a combination treatment phase (six months), a
maintenance phase (two years), and follow-up until three years
after randomization. Having completed the combination phase, Sandoz
is now reporting these data with results from the maintenance phase
of the study expected in 2018.
About GP2013
GP2013, the Sandoz proposed biosimilar MabThera®, is
being studied in a global development program which includes a
comprehensive comparison of the biosimilar candidate and the
reference product at the analytical, pre-clinical, and
clinical levels. This includes a PK and PD study in rheumatoid
arthritis (ASSIST-RA), an evaluation of the impact of transitioning
from the reference product to the proposed biosimilar rituximab
(ASSIST-RT) and a confirmatory safety and efficacy study in
follicular lymphoma (ASSIST-FL). The development program also
includes five pre-clinical studies.
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by words such as "proposed," "potential," "expected,"
"if approved," "will," "could," "would," "potentially," "yet,"
"evolving," "committed," "pipeline," "plans," "well-positioned,"
"being studied," or similar terms, or by express or implied
discussions regarding potential marketing approvals or labeling for
biosimilar rituximab or any of the other products in the Sandoz
biosimilar pipeline, or regarding potential future revenues from
biosimilar rituximab and the other products in the Sandoz
biosimilar pipeline. 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
biosimilar rituximab or any of the other products in the Sandoz
biosimilar pipeline will be submitted or approved for sale in any
market, or at any particular time. Neither can there be any
guarantee that, if approved, biosimilar rituximab will be approved
for all indications included in the reference product's label. Nor
can there be any guarantee that biosimilar rituximab or any of the
other products in the Sandoz biosimilar pipeline will be
commercially successful in the future. In particular, management's
expectations regarding biosimilar rituximab and such other Sandoz
biosimilar pipeline products could be affected by, among other
things, unexpected regulatory actions or delays or government
regulation generally; the uncertainties inherent in research and
development, including unexpected clinical trial results and
additional analysis of existing clinical data; competition in
general, including potential approval of additional versions of
biosimilar rituximab; global trends toward health care cost
containment, including government, industry and general public
pricing pressures; unexpected litigation outcomes, including
intellectual property disputes or other legal efforts to prevent or
limit Sandoz from selling biosimilar rituximab or its other
biosimilar products; the particular prescribing preferences of
physicians and patients; general economic and industry conditions;
unexpected safety, quality or 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 Sandoz
Sandoz is a global leader in generic pharmaceuticals and
biosimilars. As a division of the Novartis Group, our purpose is to
discover new ways to improve and extend people's lives. We
contribute to society's ability to support growing healthcare needs
by pioneering novel approaches to help people around the world
access high- quality medicine. Our portfolio of more than 1000
molecules, covering all major therapeutic areas, accounted for 2015
sales of USD 10.1 billion. In 2015, our products reached more than
500 million patients and we aspire to reach one billion. Sandoz is
headquartered in Holzkirchen, in Germany's Greater Munich area.
*
MabThera® is a
registered trademark of F. Hoffmann-La Roche AG
References
[1] Jurczak W et al. A Phase III efficacy and
safety study of the proposed rituximab biosimilar GP2013 versus
rituximab in patients with previously untreated advanced follicular
lymphoma.
https://ash.confex.com/ash/2016/webprogram/Paper89113.html.
Accessed December 2, 2016.
# # #
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