Masitinib study misses endpoint
01.11.2012 - French AB Science’s cancer drug Masitinib failed to improve overall survival in a Phase III study. But certain patient groups might benefit from the treatment.
The double-blind, international Phase III trial enrolled 348 patients with pancreatic cancer and compared masitinib plus Gemzar treatment with Gemzar treatment alone. There was no significant change in the overall survival time of the patients (7.7 vs. 7 months, p=0.74), said the French drugmaker. But in a subgroup of patients with an undisclosed genetic biomarker which is thought to be indicative of aggressive disease progression, the orally administered tyrosine kinase inhibitor masitinib plus Gemzar significantly improved median overall survival vs. placebo plus Gemzar (11 vs. 5 months, p=0.000038). In a second subgroup of patients with a pain intensity level above an undisclosed threshold at baseline, the orphan drug plus Gemzar also significantly improved median overall survival vs. placebo plus Gemzar (8.1 vs. 5.4 months, p=0.01). These two independent patient populations represented 65% and 45%, respectively, of the overall population, according to AB Science.
AB Science also announced that the European Medicines Agency (EMA) has accepted to review the Marketing Authorization Application (MAA) for conditional approval of masitinib in combination with Gemzar in the treatment of non-resectable, advanced adenocarcinoma pancreatic cancer „ on the basis of results from a Phase III study that showed masitinib in combination with Gemzar significantly extends overall survival in two independent patient populations having the worst prognosis.“ Masitinib targets the stem cell factor (SCF) receptor tyrosine kinase (CD117).
Masitinib has been available in Europe since the second part of 2009 as a treatment of mast cell tumors in animals (Masivet), specifically dogs. In the US it is distributed under the name Kinavet by AB Science and has been available for veterinaries since 2011.