Novartis Breakthrough Therapy LDK378 shows a marked clinical response in patients with ALK+ non-small cell lung cancer
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Novartis Breakthrough Therapy LDK378 shows a marked clinical response in
patients with ALK+ non-small cell lung cancer
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* Investigational compound LDK378 is a selective inhibitor of ALK[1], a target
found in metastatic non-small cell lung cancer (NSCLC)
* Data show 60% overall response rate in 78 patients with ALK+ NSCLC taking
LDK378 at 750 mg; will serve as basis for first filing in early 2014
* FDA designated LDK378 as Breakthrough Therapy in March and a robust clinical
development plan is underway
Basel, June 3, 2013 - Novartis today announced data on its investigational
compound LDK378 showing a marked clinical response in 78 patients with
anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer
(NSCLC) who had progressed during or after crizotinib therapy or had not been
previously treated with crizotinib[1]. The trial will be featured as an oral
presentation (abstract #8010; Monday, June 3) at the 49(th) Annual Meeting of
the American Society of Clinical Oncology (ASCO) in Chicago.
The results from the study showed an overall response rate (including complete
response [CR] and partial response [PR]) of 60% in patients with ALK+ NSCLC
taking LDK378 (750 mg/day), which includes patients who had progressed during or
after crizotinib therapy (overall response rate of 59%) and those who were
crizotinib-naïve (overall response rate of 62%)[1]. In addition to the 78
patients treated at 750 mg/day, an additional 36 patients were treated with
LDK378 at 400-750 mg/day. The study is continuing to enroll patients and
evaluations are ongoing. This pivotal trial will serve as the basis for the
first regulatory filing, anticipated in early 2014.
The most frequent adverse events (regardless of relationship to LDK378) were
nausea (73%), diarrhea (72%), vomiting (58%) and fatigue (41%). The most
frequent Grade 3/4 adverse events were alanine aminotransferase increased (19%),
aspartate aminotransferase increased (10%) and diarrhea (8%).
"These results confirm that LDK378 has activity in patients with ALK+ NSCLC,
including those who have progressed on crizotinib, as well as those who haven't
taken crizotinib," said lead investigator Alice T. Shaw, MD, PhD, Massachusetts
General Hospital Cancer Center, Boston. "LDK378 may become another standard
targeted therapy for these ALK-positive patients."
In March, LDK378 received Breakthrough Therapy designation from the US Food and
Drug Administration (FDA). The designation is intended to expedite the
development and review of drugs that treat life-threatening conditions and show
improvement over available therapies[2].
"LDK378 is representative of the Novartis targeted research approach to identify
key disease pathways and those specific patients affected by the disease," said
Hervé Hoppenot, President, Novartis Oncology. "Based on these data showing the
potential of LDK378, we are developing a robust clinical program to move it
forward as quickly as possible."
Currently, two Phase II clinical trials are actively recruiting patients
worldwide. One study, highlighted as a Trials in Progress poster at ASCO,
focuses on patients with ALK+ NSCLC who were previously treated with
chemotherapy and crizotinib (presented on Saturday, June 1 from 8:00 - 11:45 AM;
abstract #TPS8119). The second study examines LDK378 in patients who are
crizotinib-naïve. In addition, Phase III clinical trials are planned to begin in
the coming months, aiming to enroll more than 1,100 patients with ALK+ NSCLC at
sites worldwide.
Non-small cell lung cancer is the most common type of lung cancer accounting for
85-90% of all cases[3]. Approximately 3-8% of patients with NSCLC have the ALK
gene mutation[1]. There are limited treatment options for patients with ALK+
NSCLC, who tend to be non-smokers and younger than NSCLC patients without an ALK
translocation[4].
About the study
The Phase I single-arm study investigated the maximum tolerated dose, safety,
pharmacokinetics and preliminary antitumor activity of LDK378 in 114 patients
with ALK+ NSCLC (78 patients taking LDK378 at 750 mg/day and 36 additional
patients taking 400-750 mg/day). Of 114 patients evaluable for response, 79 had
progressed during or following treatment with crizotinib, and 35 patients with
NSCLC were crizotinib-naïve[1].
In the 78 patients with ALK+ NSCLC who received LDK378 at 750 mg/day, the
overall response rate was 60% (47 patients had partial responses). In the 114
patients treated with LDK378 at 400 mg/day or higher, the overall response rate
was 58% (1 patient had a complete response and 65 patients had partial
responses).
The median duration of response for patients treated at 400 mg/day or higher
(n=66) was 8.2 months (95% confidence interval [CI], 6.9-NE), with a median
progression-free survival of 8.6 months (95% CI; 5.7-9.9). The six month
duration of response rate at 750 mg/day was 61% (95% CI; 34.9-78.8).
About LDK378
LDK378 is a selective inhibitor of a cancer target called anaplastic lymphoma
kinase or ALK. Because it is an investigational compound, the safety and
efficacy profile of LDK378 has not yet been established. Access to this
investigational compound is available only through carefully controlled and
monitored clinical trials. These trials are designed to better understand the
potential benefits and risks of this compound. Because of the uncertainty of
clinical trials, there is no guarantee that LDK378 will ever be commercially
available anywhere in the world.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "will," "Breakthrough Therapy," "anticipated," "may,"
"potential," "planned," "aiming," or similar expressions, or by express or
implied discussions regarding potential marketing approvals for LDK378 or
regarding potential future revenues from LDK378. You should not place undue
reliance on these statements. Such forward-looking statements reflect the
current views of management regarding future events, and involve known and
unknown risks, uncertainties and other factors that may cause actual results
with LDK378 to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no guarantee
that LDK378 will be submitted or approved for sale in any market or at any
particular time. Nor can there be any guarantee that LDK378 will achieve any
particular levels of revenue in the future. In particular, management's
expectations regarding LDK378 could be affected by, among other things, negative
or otherwise unexpected clinical trial results, including unexpected new
clinical data and unexpected additional analysis of existing clinical data;
unexpected regulatory actions or delays or government regulation generally;
government, industry and general public pricing pressures; competition in
general; unexpected manufacturing issues; the company's ability to obtain or
maintain patent or other proprietary intellectual property protection; the
impact that the foregoing factors could have on the values attributed to the
Novartis Group's assets and liabilities as recorded in the Group's consolidated
balance sheet, and other risks and factors referred to in Novartis AG's current
Form 20-F on file with the US Securities and Exchange Commission. Should one or
more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those
anticipated, believed, estimated or expected. 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, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 129,000
full-time-equivalent associates and operate in more than 140 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] Shaw A, et al. Clinical activity of the ALK inhibitor LDK378 in advanced,
ALK-positive NSCLC. Abstract #8010. 49th American Society of Clinical Oncology
(ASCO) Chicago, IL.
[2] US Food and Drug Administration. Frequently Asked Questions: Breakthrough
Therapies. Available at:
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticA
ctFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm. Accessed May
30, 2013.
[3] American Cancer Society. Lung Cancer - Non-Small Cell Detailed Guide.
Available at: http://www.cancer.org/Cancer/LungCancer-Non-
SmallCell/DetailedGuide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-
cancer. Accessed May 30, 2013.
[4] Shaw A, et al. Targeting Anaplastic Lymphoma Kinase in Lung Cancer. Clin
Cancer Res 2011;17:2081-2086.
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Datum: 03.06.2013 - 17:30 Uhr
Sprache: Deutsch
News-ID 265871
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