AB Science announces that confirmatory Phase 3 study AB12005 with masitinib in first line pancreatic cancer with pain was successful
Paris, December 4, 2020, 8.30am
AB Science announces that confirmatory Phase 3 study AB12005 with masitinib
in first line pancreatic cancer with pain was successful and reached its primary
objective to show statistically significant increase in survival
AB Science SA (Euronext - FR0010557264 - AB) today announced that its Phase 3 study (AB12005 - NCT03766295) met its primary objective to demonstrate increase in survival in pancreatic cancer with pain.
Study AB12005 evaluated masitinib 6.0 mg/kg/day in combination with gemcitabine in first-line treatment of unresectable locally advanced or metastatic pancreatic cancer patients with pain. The study was successful if its primary objective to test a significant increase in overall survival was reached at a 2.5% level of statistical significance in either the overall population with pain or in the population with unresectable locally advanced tumors 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%.
Masitinib also reduced pain relative to the control arm in patients with unresectable locally advanced tumors, as demonstrated by a between group difference that reached statistical significance or approached significance at each timepoint. In pancreatic cancer, there is evidence that pain is a clinical predictor of poor prognosis . Study AB12005 demonstrated that mast cells are associated with pain and that blocking mast cells, as masitinib does, is able to reverse the poor prognosis of patients with unresectable locally advanced tumors with pain.