ABSCIENCES (EPA:AB) AB Science announces presentation at ASCO of its 4-year follow-up phase 2 data of masitinib in first line treatment of GIST
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19/01/2011 18:30
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Paris, 19th January 201, 18:30 pm
AB Science announces presentation at ASCO of its 4-year follow-up phase 2 data
of masitinib in first line treatment of GIST
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical
company specialising in the research, development and commercialisation of
protein kinase inhibitors (PKIs), announced today the presentation of its 4-year
follow-up data from a phase 2 clinical study of masitinib in the first line
treatment of locally advanced or metastatic gastrointestinal stromal tumor
(GIST), at the 2011 ASCO Gastrointestinal Cancers Symposium.
Even though imatinib (Glivec(r)) has dramatically increased prognosis in this
indication, with a median survival time of 55 months and median progression
free survival (PFS) of 18 months, according to Blanke et al (JCO 2008), there
is still a need for more effective medication in this disease.
The data presented with masitinib are especially important because masitinib
is currently being evaluated in a phase 3 head-to-head study with imatinib
(Glivec(r)) in first line treatment. Although the phase 2 study design was a
single masitinib arm, it is interesting to compare these results with the
published results of imatinib. In particular, the PFS of imatinib in first
line treatment is not expected to have changed with time and can therefore be
reasonably compared to the PFS of masitinib from this phase 2 study.
PROGRESSION FREE
SURVIVAL (PFS) Rate Rate Rate Rate
Median PFS Year 1 Year 2 Year 3 Year 4
Masitinib (n=30) 41 months 77% 61% 57% 35%
Imatinib (Publication*) 18 months ≈ 62% 42% ≈ 30% ≈ 25%
Rate Rate Rate Rate
SURVIVAL (OS) Median OS Year 1 Year 2 Year 3 Year 4
Masitinib (n=30) Not reached 97% 90% 87% 75%
Imatinib (Publication*) 55 months ≈ 86% 76% ≈ 61% ≈ 58%
* Blanke et al, JCO 2008
The abstract to be presented at the 2011 ASCO Gastrointestinal Cancers
Symposium is entitled " Overall survival benefit with masitinib mesylate in
imatinib-naïve locally advanced or metastatic gastro-intestinal stromal tumor
(GIST): 4 years follow-up of the French Sarcoma Group phase II trial " and can
be downloaded at
http://ns207863.ovh.net/~abscienc/file_bdd/1295456962_ascogi2011blayetal.pdf
Masitinibis also being developed for patients resistant to imatinib (Glivec(r))
in an on-going phase 2 study, which is comparing masitinib to the approved
second line drug, sunitinib (Sutent(r)). Results should be available in 2012.
Key variables assessed are overall survival and PFS.
GIST is a disease that is driven by the juxta-membrane mutation of c-Kit, the
same genetic mutation on the same gene as that found in canine mast cell
tumours, for which masitinib has been registered by EMA and FDA.
Alain Moussy, Chairman and CEO of AB Science declared " These
results are encouraging for mastinib in GIST first line, in particular on PFS
with a median of 41 months (versus 18 months for imatinib according to the
literature). PFS rate at 3 years was 57% for masitinib (compared to just 30% for
imatinib) and PFS rate at 4 years was 35% for masitinib (versus 25% for
imatinib, according to publication). In the event that this trend is confirmed
during phase 3, 200 patients could be enough to demonstrate superiority of
masitinib over imatinib. Both the phase 3 in GIST first line and the phase 2 in
GIST second line are fully financed ".
Details of the clinical development program (on next page).
About masitinib
Masitinib is a new orally administered tyrosine kinase inhibitor that targets
mast cells, important cells for immunity, as well as a limited number of
kinases that play key roles in various cancers. Owing to its novel 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. Through its activity of inhibiting certain kinases that are
essential in some oncogenic processes, masitinib may have an effect on tumour
regression, alone or in combination with chemotherapy. Through its activity on
the mast cell and certain kinases essential to the activation of the
inflammatory cells and fibrosing tissue remodelling, masitinib can have an
effect on the symptoms associated with some inflammatory and central nervous
system diseases.
About AB Science
Founded in 2001, AB Science is a pharmaceutical company specialising in the
research, development and commercialisation of protein kinase inhibitors
(PKIs), a new class of targeted molecules whose action is to modify signalling
pathways within cells. Through these PKIs, the Company targets diseases with
high unmet medical needs (cancer, inflammatory diseases and central nervous
system diseases), in both human and veterinary medicines. Thanks to its
extensive research and development capabilities, AB Science has its own
portfolio of molecules. Masitinib, a lead compound, has already been registered
in veterinary medicine in Europe and in the USA and is pursuing nine phase 3
studies in human medicine, including four studies on-going in pancreatic
cancer, GIST, in metastatic melanoma expressing JM mutation of c-Kit, and
mastocytosis.
Further information is available on AB Science's website: www.ab-science.com
This document contains prospective information. No guarantee can be given as
for the realisation 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 & Press Relations
Contacts Citigate Dewe Rogerson :
Agnès Villeret - Tel: +33 1 53 32 78 95 - agnes.villeret@citigate.fr
* * *
DETAILS OF THE CLINICAL DEVELOPMENT PROGRAM IN GIST
Characteristics of the phase 3 in First line treatment of GIST
A prospective, multicenter, randomized, open-label, active-controlled,
2-parallel group, phase III study to compare efficacy and safety of masitinib at
7.5 mg/kg/day to imatinib at 400 or 600 mg in treatment of patients with
gastro-intestinal stromal tumour in first line medical treatment
Patients will be randomized into two groups:
* Group 1: Patients will receive masitinib at 7,5 mg/kg/day
* Group 2: Patients will receive receive imatinib at 400 or 600 mg per day
The primary criterion will be the Overall Progression Free Survival
(PFS), defined as the delay between the date of randomisation to the date of
documented progression or any cause of death during the study. Overall Survival
will be the main secondary criterion.
Characteristics of the phase 2 in Second line treatment of GIST
A prospective, multicenter, randomized, open-label, active-controlled,
2-parallel group, phase II study to compare efficacy and safety of masitinib
at 12 mg/kg/day to sunitinib at 50 mg/day in treatment of patients with
gastro-intestinal stromal tumor resistant to imatinib
Patients will be randomized in two groups:
* Group 1: Patients will receive masitinib at 12 mg/kg/day
* Group 2: Patients will receive sunitinib at 50 mg/day
The primary criterion will be the Overall Progression Free Survival (PFS),
defined as the delay between the date of randomisation to the date of
documented progression or any cause of death during the study. Overall Survival
will be the main secondary criterion.