Novartis next generation CAR-T cell therapy CTL119 combined with ibrutinib shows high rate of responses in CLL patients
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Novartis International AG /
Novartis next generation CAR-T cell therapy CTL119 combined with ibrutinib shows
high rate of responses in CLL patients
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The issuer is solely responsible for the content of this announcement.
* Eight of nine evaluable patients tested had no signs of CLL in their bone
marrow at three months.
* CTL119 is a humanized CD19-directed CAR-T cell therapy being developed in
collaboration with the University of Pennsylvania
* Novartis is committed to advancing a portfolio of next-generation CAR-T cell
therapies
Basel, May 30, 2017 - Novartis announced findings from a pilot study
(NCT02640209) of CTL119 in combination with ibrutinib* in patients with
relapsed/refractory chronic lymphocytic leukemia (CLL) who had been taking
ibrutinib for at least six months and who were not in complete remission. All
study patients had to have failed at least one prior regimen before ibrutinib or
carried high-risk cytogenetics or mutations. The results, which will be
presented at the upcoming 53(rd) Annual Meeting of the American Society of
Clinical Oncology (ASCO; abstract #7509; Monday, June 5, 1:15 PM CDT), that
eight of nine evaluable patients had no signs of CLL in their bone marrow at
three months. One of those patients had a partial response [1].
"The data from this pilot study support the potential for CTL119, when combined
with the kinase inhibitor ibrutinib, to induce clinically-significant responses
in high-risk CLL patients who were unlikely to achieve a complete remission on
ibrutinib alone," said James Bradner, president of the Novartis Institutes for
BioMedical Research. "CTL119 represents one of our latest advances in CAR-T cell
therapy research and our broader commitment to pioneering breakthrough immuno-
oncology treatments."
The findings will be presented by Saar Gill, MD, PhD, an assistant professor of
Hematology-Oncology in the Perelman School of Medicine and the Abramson Cancer
Center of the University of Pennsylvania.
CTL119 is a humanized CD19-directed chimeric antigen receptor T cell (CAR-T)
cell therapy, which is different from typical small molecule or biologic
therapies because it is manufactured for each individual patient using their own
cells. During the treatment process, T cells are drawn from a patient's blood
and reprogrammed in the laboratory to create T cells that are genetically coded
to hunt the patient's cancer cells and other B-cells expressing a particular
antigen.
Results from the pilot study also showed that eight of nine patients had no
signs of CLL in their bone marrow at three months as tested by flow cytometry
and/or analysis for minimal residual disease (MRD)[1]. MRD, which measures the
presence of residual abnormalities in the blood and bone marrow at the molecular
level following treatment, is important because it can be an indicator of
potential relapse[2].
CT scans were performed to measure the inclusion of CLL in the spleens and lymph
nodes of study patients. A number of patients showed improvements in the burden
of disease in their spleens and lymph nodes at three months, though radiologic
responses are less clear cut and they require longer follow-up[1].
In the study, 10 patients experienced cytokine release syndrome (CRS), two of
which were grade 3. However, no patients required treatment with tocilizumab**
and all patients recovered from CRS. One patient developed tumor lysis syndrome
and two patients had febrile neutropenia [1].
CLL is one of the most common types of adult leukemia, which typically
progresses slowly over time[3]. The majority of patients will relapse after
initial therapy[4], and newer targeted therapies must be taken continuously for
an indefinite period of time[5]. These are clear indications of the high unmet
medical need for new therapies for CLL.
About the Novartis CAR-T Program
In 2012, Novartis and the University of Pennsylvania entered into a global
collaboration to further research, develop and then commercialize CAR-T cell
therapies for the investigational treatment of cancers. In March 2017, Novartis
announced that the US Food and Drug Administration (FDA) accepted the company's
Biologics License Application filing and granted priority review for CTL019 in
the treatment of relapsed/refractory (r/r) pediatric and young adult patients
with B-cell acute lymphoblastic leukemia. In April 2017, FDA granted
Breakthrough Therapy designation to CTL019 for relapsed/refractory diffuse large
B-cell lymphoma.
During the collaboration between Novartis and the University of Pennsylvania,
researchers generated the humanized anti-CD19 CAR, CTL119. CTL119 is in initial
clinical development for multiple B-cell malignancies. Because CTL119 and CTL019
are investigational therapies, 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
the uncertainty of clinical trials, there is no guarantee that CTL119 or CTL019
will become commercially available.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "next generation," "being developed," "committed," "will,"
"upcoming," "potential," "commitment," "investigational," "priority review,"
"Breakthrough Therapy designation," or similar terms, or by express or implied
discussions regarding potential marketing approvals for CTL119 and CTL019, or
regarding potential future revenues from CTL119 and 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 CTL119
or CTL019 will be submitted or approved for sale in any market, or at any
particular time. Neither can there be any guarantee that the collaboration with
the University of Pennsylvania will achieve any or all of its intended goals and
objectives or be successful, or at any particular time. Nor can there be any
guarantee that CTL119 or CTL019 will receive regulatory approval or be
commercially successful in the future. In particular, management's expectations
regarding CTL119, CTL019 and the collaboration with the University of
Pennsylvania could be affected by, among other things, the achievement of, or
failure to achieve, any or all of the intended goals and objectives of the
collaboration with the University of Pennsylvania; the uncertainties inherent in
research and development, including clinical trial results and additional
analysis of existing clinical data; 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 and
reimbursement pressures; 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.
Notes
* Ibrutinib is marketed as IMBRUVICA®, a registered trademark owned by
Pharmacyclics LLC.
** Tocilizumab is marketed as ACTEMRA®, which is a registered trademark of
Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
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,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
118,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] Gill S, Frey N, et al. Anti-CD19 CART cells combined with ibrutinib
induce a high rate of remission in CLL. June 5, 1:15 PM CDT. 53rd
Annual Meeting of the American Society of Clinical Oncology.
[2] Campana, Dario. Minimal Residual Disease in Acute Lymphoblastic
Leukemia. Seminars in hematology 46.1 (2009): 100-106. PMC. Web. 22 May
2017.
[3] National Cancer Institute. Chronic Lymphocytic Leukemia Treatment
(PDQ®)-Patient Version. Available at
https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq.
Accessed May 2017.
[4] Veliz M, Pinilla-Ibarz J. Treatment of relapsed or refractory chronic
lymphocytic leukemia. Cancer Control. 2012; 1:37-53
[5] National Comprehensive Cancer Network. NCCN Clinical Practice
Guidelines in Oncology: Chronic Lymphocytic Leukemia/Small Lymphocytic
Leukemia. Version 2.2017. 21 February 2017.
# # #
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Source: Novartis International AG via GlobeNewswire
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Datum: 30.05.2017 - 23:00 Uhr
Sprache: Deutsch
News-ID 545334
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Business News
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