PRESS RELEASE
NEW INDEPENDENT PUBLICATION IN THE PEER-REVIEWED SCIENTIFIC REVIEW CELLS CONFIRMS THE ROLE OF MASITINIB AS A POTENTIAL THERAPY IN PANCREATIC CANCER
IDENTIFICATION OF TWO TISSUE BIOMARKERS THAT COULD POTENTIALLY SERVE AS PREDICTIVE BIOMARKERS OF RESPONSE FOR MASITINIB TREATMENT
This study examined mast cell activity through immunohistochemistry and image analysis, in a series of non-metastatic pancreatic cancer patients. Results showed that:
- Various markers of mast cell activity were increased in pancreatic ductal adenocarcinoma tissue as compared with adjacent normal tissue.
- Mast cells are strongly associated with angiogenesis in pancreatic cancer tissue.
- The density of mast cells positive for tryptase (MCDPT) and area of mast cells positive for tryptase (MCAPT) are tissue biomarkers that could be predictive of response to masitinib (anti‐c‐Kit therapy).
This research supports results from the confirmatory phase 3 study, AB12005, that evaluated masitinib at 6.0 mg/kg/day in combination with gemcitabine as a first-line treatment of unresectable locally advanced or metastatic pancreatic cancer patients with pain; pain being hypothesized to be a marker of mast cell activation.
As a reminder [2], study AB12005 met its primary objective to demonstrate increase in survival in pancreatic cancer patients with pain. In the population with unresectable locally advanced tumors with pain, the masitinib treatment-arm showed a significant improvement in overall survival (OS) relative to the control arm. The between group difference in median OS was 1.8 months (p=0.007) in favor of masitinib (13.0 months in masitinib arm versus 11.2 months in control group), with a 0.46 hazard ratio (HR) of death, which represents a reduction in risk of death of 54% for masitinib-treated patients relative to control. Results on the primary endpoint were consistent with secondary analysis in progression free survival (PFS), which measures the time to tumor progression or death (whichever occurs first) from the start of treatment. The between group difference in median PFS was 1.8 months (p=0.039) in favor of masitinib (7.4 months in masitinib arm versus 5.6 months in control group), with a 0.47 hazard ratio representing a reduction in risk of having a progression or death of 53%. The safety of masitinib 6.0 mg/kg/day in combination with gemcitabine compared favorably to that of gemcitabine as a single agent, with fewer adverse event and severe adverse events reported in the masitinib arm as compared with the control arm.
[1] Ammendola, M.; Curr, G.; Laface, C.; Zuccal, V.; Memeo, R.; Luposella, F.; Laforgia, M.; Zizzo, N.; Zito, A.; Loisi, D.; et al. Mast Cells Positive for c‐Kit Receptor and Tryptase Correlate with Angiogenesis in Cancerous and Adjacent Normal Pancreatic Tissue. Cells 2021, 10, 444. https://doi.org/10.3390/cells10020444
[2]
About Cells
Cells is an international, peer-reviewed, open access, journal of cell biology, molecular biology, and biophysics. Cells is published monthly online by MDPI.
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 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.
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Attachment
- Masitinib Pancreas Eng VF
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