New interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent efficacy to reference product
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Novartis International AG /
New interim data demonstrate Sandoz proposed biosimilar rituximab has equivalent
efficacy to reference product
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* 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.
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations(at)novartis.com
Eric Althoff Duncan Cantor
Novartis Global Media Relations Sandoz Global Communications
+41 61 324 7999 (direct) +49 (0) 170 650 6067 (mobile)
+41 79 593 4202 (mobile) duncan.cantor(at)sandoz.com
eric.althoff(at)novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations(at)novartis.com
Central North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Sloan Pavsner +1 212 830 2417
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Media release (PDF):
http://hugin.info/134323/R/2061618/773254.pdf
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Source: Novartis International AG via GlobeNewswire
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