AB Science today announced that results from masitinib study
AB12005 in pancreatic cancer have been presented at the 2021 ASCO
Annual Meeting
PRESS RELEASE
RESULTS FROM MASITINIB STUDY AB12005 IN PANCREATIC
CANCER PRESENTED AT THE ASCO
ANNUAL MEETING WITH THE FULL ABSTRACT PUBLISHED IN
THE JOURNAL OF CLINICAL ONCOLOGY
Paris, 10 June, 2021, 6.30pm CET
AB Science SA (Euronext -
FR0010557264 - AB) today announced that results from masitinib
study AB12005 in pancreatic cancer, have been presented at the 2021
American Society of Clinical Oncology (ASCO) Annual Meeting by the
principal coordinating investigator Dr Joël Ezenfis (Head of the
Medical Oncology Department the Centre Hospitalier Sud Francilien,
France). The ASCO Annual Meeting, one of the world’s largest
meetings for oncology medical professions, was held from June 4–8
as a virtual format this year.
Study AB12005 was a placebo controlled,
randomized (2:1) trial, evaluating oral masitinib (6 mg/kg/d) plus
gemcitabine (1000 mg/m²) in chemo-naïve unresectable locally
advanced pancreatic cancer (LAPC) or metastatic cancer with pain
criteria (defined as visual analog scale of pain intensity >20
or patient taking an opioid analgesics dose ≥1 mg/kg/d). The study
was successful if the difference in median OS (primary endpoint)
relative to control, reached a 2.5% level of statistical
significance for either the predefined LAPC subgroup (n=92) or the
overall population (n=379).
The prerecorded presentation entitled ‘Masitinib
plus gemcitabine as first-line treatment of pancreatic cancer with
pain: Results from phase 3 study AB12005’ was released on Friday
4th June as part of the Gastrointestinal Cancer Poster Discussion
Session, and the abstract has been published in the Journal of
Clinical Oncology [1]
(https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.4018).
Highlights from the presentation included:
- Masitinib plus gemcitabine confers
a meaningful overall survival benefit of +1.8 months relative to
control in LAPC patients with pain, and a significant 54% reduced
risk of death (p=0.005).
- Masitinib plus gemcitabine
increased median progression free survival by 3.6 months,
corresponding to a significant 54% reduced risk of disease
progression (p=0.004) in LAPC patients with pain.
- No survival benefit was seen for
the overall study population, which included metastatic
patients.
Joël Ezenfis said: “These results are
confirmatory for a positive benefit/risk in patients with
unresectable locally advanced pancreatic ductal adenocarcinoma with
pain criteria, a population that was previously identified from
phase 3 study AB07012 [2]. For study AB12005, an 18-month overall
survival rate of 34% for the masitinib treatment-arm versus 10% for
the placebo arm was observed. Of equal importance, toxicities for
the masitinib and gemcitabine combination were manageable with
similar rates of severe and serious adverse events relative to
control”.
AB12005 Study
Design
Study AB12005 was a randomized,
placebo-controlled, phase 3 study of masitinib in first-line
treatment of unresectable locally advanced or metastatic pancreatic
cancer patients with pain at baseline or taking opioids.
The pre-specified primary endpoint was overall
survival. The primary analysis was pre-specified both in the
overall population and also in patients with unresectable locally
advanced tumors, with alpha spending split at a 2.5% level of
significance between the overall population (2.5%) and locally
advanced subgroup (2.5%). The distinction between unresectable
locally advanced or metastatic disease status was a stratification
factor, thereby ensuring that treatment-arms were unbiased for this
known prognostic factor. Secondary endpoints included progression
free survival according to central RECIST criteria and change in
pain from baseline.
The study enrolled 383 patients (randomization
2:1 between masitinib and placebo) with i) histologically or
cytologically confirmed adenocarcinoma of the pancreas,
unresectable locally advanced or metastatic stage, ii) pain related
to the disease (Visual Analogue Scale > 20 mm or opioid
analgesics at a dose ≥ 1 mg/kg/day), and iii) chemotherapy naïve
for the advanced/metastatic disease. 92 patients had unresectable
locally advanced with pain criteria.
Efficacy analysis was performed in the modified
intent-to-treat (mITT) population, which included all randomized
patients who took at least one dose of study treatment
(masitinib/placebo) and with pain criteria (VAS > 20 and/or
patients treated with opioid analgesics dose ≥ 1 mg/kg/day at
baseline). There was a difference of 4 patients between the ITT
population and the mITT population, with 1 patient receiving no
study treatment and 3 patients without pain criteria.
Reference
[1] Joel Ezenfis, et al. Masitinib plus gemcitabine as
first-line treatment of pancreatic cancer with pain: Results from
phase 3 study AB12005. DOI: 10.1200/JCO.2021.39.15_suppl.4018
Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021)
4018-4018.[2] Deplanque 2015, Ann Oncol. doi:
10.1093/annonc/mdv133.
http://annonc.oxfordjournals.org/content/26/6/1194.
About masitinibMasitinib 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 microglia 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 ScienceFounded 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.
AB Science has developed a proprietary portfolio of molecules and
the Company’s lead compound, masitinib, has already been registered
for veterinary medicine and is developed in human medicine in
oncology, neurological diseases, inflammatory diseases and viral
diseases. The company is headquartered in Paris, France, and listed
on Euronext Paris (ticker: AB).
Further information is available on AB Science’s website:
www.ab-science.com.
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- CP Pancreatic ASCO2021 Safety vEng VF
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