AB Science announces that confirmatory Phase 3 study AB12005 with masitinib in first line pancreatic cancer with pain was successful - Seite 3

Prof. Olivier Hermine, president of the Scientific Committee of AB Science and member of the Académie des Sciences in France, said: “This study is particularly important as it confirms the relevance of targeting mast cells and macrophages in oncology. We had previously observed the benefit of masitinib targeting mast cells and macrophages in cancer through in vitro and in animal assays in my laboratory. This study validates the benefit of masitinib in humans in the most difficult-to-treat cancer. We can now state that masitinib is an anti-metastatic drug that could be useful in patients at high risk of developing metastases. In addition, it validates the role of mast cells in pain and the acceptable safety profile of masitinib even in combination with chemotherapy.”

Alain Moussy, co-founder and CEO of AB Science said: “This is a major achievement for masitinib in oncology. The next step is to discuss with the Health Authorities a potential filing for marketing authorization application of masitinib in the first line treatment of unresectable locally advanced pancreatic cancer associated with pain”.

AB Science plans to present complete study results at an upcoming medical meeting.

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 a 5% alpha spending split, which corresponds to the chance factor threshold below which the statistical test is considered significant by regulatory authorities, of 2.5% for the overall population and 2.5% for the locally advanced subgroup. 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.