Novartis highlights CTL019 data showing its potential in the treatment of specific types of hard-to-treat non-Hodgkin lymphoma
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Novartis International AG /
Novartis highlights CTL019 data showing its potential in the treatment of
specific types of hard-to-treat non-Hodgkin lymphoma
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* Data show adult patients may achieve durable response rates, with 13 of 19
evaluable patients with relapsed/refractory non-Hodgkin lymphomas responding
to therapy[1]
* Recent milestones for Novartis CAR therapy program include initiation of
global Phase II multi-center CTL019 study and activation of cell processing
facility
* Data also highlight preliminary safety and efficacy data for CTL019 in other
indications
Basel, Switzerland, June 1, 2015 - Novartis is highlighting data from an ongoing
Phase II clinical study of CTL019, an investigational chimeric antigen receptor
(CAR) T cell therapy, that indicate its potential in the treatment of specific
types of hard-to-treat non-Hodgkin lymphoma. Findings from the ongoing study
conducted by the University of Pennsylvania's Perelman School of Medicine (Penn)
in adults with relapsed or refractory (r/r) diffuse large B-cell lymphoma
(DLBCL) and follicular lymphoma (FL) found an overall response rate (ORR) of
100% in patients with FL and 50% in patients with DLBCL[1]. Thirteen of 19
evaluable patients responded to the therapy. Eleven achieved a complete response
(CR) and two experienced a partial response (PR) to treatment[1]. These results
will be presented in an oral session at the 51(st) American Society of Clinical
Oncology (ASCO) Annual Meeting on Monday, June 1 (Abstract #8516, June 1, 3:24
p.m. CDT)[1].
"The results from this ongoing study of CTL019 are encouraging, as we now have
data through six months showing that patients may have achieved durable overall
response rates," said lead investigator Stephen Schuster, M.D., associate
professor, division of Hematology/Oncology at the University of Pennsylvania,
Abramson Cancer Center. "These data support our ongoing efforts to determine the
potential role of CTL019 in improving outcomes for patients with certain types
of B-cell lymphomas."
Study results include 19 adult patients (12 with DLBCL and seven with FL) who
were evaluable for response[1]. The study found that six patients with a PR to
treatment at three months achieved a CR by six months[1]. Two patients with a PR
experienced disease progression at 6 and 12 months after treatment[1]. Median
patient follow-up is 274 days for the patients with DLBCL and 290 days for the
patients with FL[1]. In the study, two patients developed cytokine release
syndrome (CRS) of grade 3 or higher at peak T cell expansion[1].
"These new CTL019 findings are inspiring as we continue clinical research with
our collaborators at the University of Pennsylvania, with the goal of altering
the course of cancer care and treating areas of critical unmet need," said Usman
Azam, Global Head, Cell & Gene Therapies Unit, Novartis Pharmaceuticals. "As
Novartis initiates the Phase II multi-center global study of CTL019, this
reinforces our commitment to furthering the new frontier of cell and gene
therapies."
Additional CTL019 data being presented at ASCO include the preliminary safety
and efficacy findings of a Phase I study investigating the use of CTL019 in the
treatment of multiple myeloma (Abstract #8517, June 1, 3:36 p.m. CDT)[2]. This
study adds to the growing body of data on CARTs and supports the advancement of
the expanding pre-clinical and early clinical research pipeline at Novartis.
Novartis has initiated a Phase II multi-center global study of CTL019 in
pediatric patients with r/r acute lymphoblastic leukemia (ALL). This study has
opened in the United States, with the intention of expanding into other
countries as soon as possible. Further, Novartis has begun to process patient
cells at its cell processing facility in Morris Plains, N.J., and will utilize
the facility in the Phase II multi-center global study. The facility is the
first US Food and Drug Administration (FDA)-approved Good Manufacturing
Practices quality site for a cell therapy.
Novartis and Penn have an exclusive global collaboration to research, develop
and commercialize CAR T cell therapies for the investigational treatment of
cancers. In July 2014, the FDA designated CTL019 as a Breakthrough Therapy for
the treatment of pediatric and adult patients with r/r ALL under the Penn
Investigational New Drug application (IND). Breakthrough Therapy designation is
intended to expedite the development and review of drugs that treat serious or
life-threatening conditions if the therapy has demonstrated substantial
improvement over an available therapy on at least one clinically significant
endpoint. Novartis holds the worldwide rights to CARs developed through the
collaboration with Penn for all cancer indications, including the lead program,
CTL019.
About CTL019
CTL019 uses CAR technology to reprogram a patient's own T cells to "hunt" cancer
cells that express specific proteins, called CD19. After they have been
reprogrammed, the T cells (now called CTL019) are re-introduced into the
patient's blood; they proliferate and bind to the targeted CD19+ cancer cells
and potentially kill these tumor cells.
Because CTL019 is an investigational therapy, the safety and efficacy profile
has not yet been established. Access to investigational therapies is available
only through carefully controlled and monitored clinical trials. These trials
are designed to better understand the potential benefits and risks of the
therapy. Because of uncertainty of clinical trials, there is no guarantee that
CTL019 will ever be commercially available anywhere in the world.
About Cytokine Release Syndrome
After CTL019 infusion, cytokine release syndrome (CRS) may occur when the
engineered cells become activated and multiply in the patient's body resulting
in the release of cytokines. During CRS, patients typically experience varying
degrees of flu-like symptoms with high fevers, nausea, muscle pain, and in some
cases, low blood pressure and breathing difficulties. CRS severity correlates
with disease burden. Additionally, CRS also can occur in other non-CAR therapy
settings including some monoclonal antibodies.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "potential," "initiation," "ongoing," "will," "encouraging,"
"inspiring," "continue," "goal," "commitment," "growing," "initiated,"
"intention," "investigational," "Breakthrough Therapy," "intended," "yet," or
similar terms, or by express or implied discussions regarding potential
marketing approvals for CTL019, or regarding potential future revenues from
CTL019. 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 CTL019 will be submitted or approved
for sale in any market, or at any particular time. Nor can there be any
guarantee that CTL019 will be commercially successful in the future. In
particular, management's expectations regarding CTL019 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 excluding impairment and
amortization charges). Novartis Group companies employ approximately 120,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Schuster, Stephan J. et al. (1 June 2015). Phase IIa Trial of Chimeric
Antigen Receptor Modified T Cells Directed Against CD19 (CTL019) in Patients
with Relapsed or Refractory CD19+ Lymphomas [oral presentation]. 2015 American
Society of Clinical Oncology Annual Meeting: Abstract 8516
[2] Garfall, Alfred L. et al. (1 June 2015). Safety and Efficacy of Anti-CD19
Chimeric Antigen Receptor (CAR)-Modified Autologous T Cells (CTL019) in Advanced
Multiple Myeloma [oral presentation]. 2015 American Society of Clinical Oncology
Annual Meeting: Abstract 8517
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Datum: 01.06.2015 - 22:00 Uhr
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