AB Science Reports Positive Phase 2 Clinical Study Data of
Masitinib in Triple Negative Breast Cancer
Data submitted for publication to the American Society
of Clinical Oncology (ASCO) 2015 Annual Meeting
Paris, France, March 12, 2015 (GLOBE NEWSWIRE)
-- AB Science SA (NYSE Euronext - FR0010557264 - AB), a
pharmaceutical company specializing in the research, development
and commercialization of protein kinase inhibitors (PKIs), today
announced positive efficacy and safety results from a phase 2 study
with masitinib in patients with triple negative breast cancer
(TNBC).
This was a prospective, multicenter, open-label,
randomized, uncontrolled, phase 1b/2 study to evaluate efficacy and
safety of masitinib in association with chemotherapy for the
treatment of TNBC. Patients received masitinib in combination with
carboplatin and/or gemcitabine.
In the cohort receiving masitinib in combination
with carboplatin and gemcitabine, 37% of patients enrolled were in
first-line of treatment, 16% were in second-line of treatment and
47% were in third-line of treatment or beyond. For the overall
cohort, median overall survival was 10.2 months and median
progression-free survival was 4.7 months. Objective response rate
was 43%.
The efficacy of masitinib in combination with
carboplatin and gemcitabine compares favorably to median OS of 7.7
months and response rate of 32% published for carboplatin plus
gemcitabine in the treatment of TNBC1.
A statistical test was pre-defined in this phase
2 study in order to detect a superiority trend on the overall
survival between the median value of the study and historical
median value. The result of this test enables to determine whether
or not a confirmatory phase III could be initiated. This
statistical test is based on the upper bound for the confidence
interval of Hazard Ratio lower than 1, estimated from the median
Overall Survival (OS) observed in this phase 2 study and the
historical benchmark. In the masitinib + gemcitabine + carboplatin
group, upper bound of the confidence interval for OS hazard ratio
is estimated to 0.70, permitting to justify the launch of a larger
study. AB Science is currently discussing with the experts of the
disease the next steps of clinical development.
Full safety and efficacy data has been submitted
for publication to the American Society of Clinical Oncology (ASCO)
2015 Annual Meeting.
"The phase 2 efficacy results of masitinib in
combination with carboplatin and gemcitabine for the treatment of
advanced triple negative breast cancer are quite encouraging," said
Professor Mario Campone of the Institut de Cancérologie de l'Ouest,
Nantes, France, and the principal investigator of this study. "A
significant unmet medical need still exists for treatment of
advanced triple negative breast cancer, and the development of
targeted agents such as masitinib in combination with cytotoxic
drugs has potential to improve patient survival in this
disease."
TNBC is more aggressive than other forms of
breast cancer, with fewer treatment options and no drug registered
in this specific indication. The benchmark for median overall
survival in metastatic breast cancer is estimated at 18 months2 in
second-line of treatment, TNBC not included, whereas it is less
than 7.7 months in second-line treatment of TNBC. Hence, there is
still a high unmet medical need in this disease.
Breast cancer remains the second most common
cancer in the world, and kills more women than any other cancer
type. The incidence of breast cancer is reported as approximately
600,000 patients in the USA and Europe, and the mortality rate was
of 130,000 patients3. It is estimated that 15% of patients have
TNBC.
It is also estimated that up to 40% of those
diagnosed with breast cancer will develop advanced disease within
10 years.
With these hypotheses, the number of eligible
patients for treatment of advanced triple negative breast cancer is
estimated to be 36,000 per annum in Europe and USA.
1 Shaughnessy. N Engl J Med 2011;364:205-14. /
Note :The referenced study enrolled 60% of patients in first-line,
and 40% in second-line or beyond.
2 References from meta-analysis [1] Kaufmann M
et al, Eur J Cancer, 2010 Dec; 46(18):3184-91 [2] Barrios CH et al,
Breast Cancer Res Treat. 2010 May;121(1):121-31 [3] Sparano J et
al, J Clin Oncol. 2010 Jul 10;28(20):3256-63 [4]Stockler M et al, J
Clin Oncol. 2011 Dec 1;29(34):4498-504 [5]Robert NJ et al, C Clin
Oncol. 2011 Apr 1;29(10) [6]Baselga J et al, J Clin Oncol.
2012 May 1;30(13) [7]Blum LJ et al, Breast Cancer Res Treat. 2012
Dec;136(3):777-88 [8]Park Y et al, Journal of tumor, 2014 April 18
2(4):113-121
3http://eco.iarc.fr/eucan/ ;
http://seer.cancer.gov/statfacts/html/breast.html
Status of masitinib clinical development in
human medicine Masitinib is currently developed in 13 phase III
indications; 7 in oncology, 3 in inflammatory diseases, and 3 in
neurodegenerative diseases. Additionally, a large phase II clinical
program is ongoing, mainly in oncology. In case of positive
results, phase III studies will be initiated following these phase
II studies. Overall, clinical development has been initiated in
more than 30 countries, without any licensing agreement. Therefore,
AB Science has retained full ownership of masitinib.
About masitinib Masitinib is a new orally
administered tyrosine kinase inhibitor that targets mast cells and
macrophages, important cells for immunity, through inhibiting a
limited number of kinases. Based on its unique mechanism of action,
masitinib can be developed in a large number of conditions in
oncology, in inflammatory diseases, and in certain diseases of the
central nervous system. In oncology due to its immunotherapy
effect, masitinib can have an effect on survival, alone or in
combination with chemotherapy. Through its activity on mast cells
and consequently the inhibition of the activation of the
inflammatory process, masitinib can have an effect on the symptoms
associated with some inflammatory and central nervous system
diseases and the degeneration of these diseases.
About AB Science Founded in 2001, AB
Science is a pharmaceutical company specializing in the research,
development and commercialization of protein kinase inhibitors
(PKIs), a class of targeted proteins whose action are key in
signaling pathways within cells. Our programs target only diseases
with high unmet medical needs, often lethal with short term
survival or rare or refractory to previous line of treatment in
cancers, inflammatory diseases, and central nervous system
diseases, both in humans and animal health. AB Science has
developed a proprietary portfolio of molecules and the Company's
lead compound, masitinib, has already been registered for
veterinary medicine in Europe and in the USA. The company is
currently pursuing thirteen phase 3 studies in human medicine in
first-line and second-line GIST, metastatic melanoma expressing JM
mutation of c-Kit, multiple myeloma, metastatic colorectal cancer,
metastatic prostate cancer, pancreatic cancer, mastocytosis, severe
persistent asthma, rheumatoid arthritis, Alzheimer's disease,
progressive forms of multiple sclerosis, and Amyotrophic Lateral
Sclerosis. The company is headquartered in Paris, France, and
listed on Euronext Paris (ticker: AB).
Further information is available on AB Science
website: www.ab-science.com
This document contains prospective information.
No guarantee can be given as for the realization of these
forecasts, which are subject to those risks described in documents
deposited by the Company to the Authority of the financial markets,
including trends of the economic conjuncture, the financial markets
and the markets on which AB Science is present.
* * *
AB Science - Financial Communication & Media
Relations
investors@ab-science.com
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