AB Science announces that confirmatory Phase 3 study AB12005 with masitinib in first line pancreatic cancer with pain was successful - Seite 2

In the overall population including both locally advanced and metastatic pancreatic cancer patients with pain, no survival benefit was detected, suggesting that masitinib treatment should be initiated early in the course of the disease, prior to metastasis.

From the first Phase 3 study AB07012 [2] and literature [3], around 50% of patients with pancreatic cancer had pain intensity (VAS > 20) and 25% to 50% of pancreatic cancer patients are patients with unresectable locally advanced tumors.

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:

• 96.3% of patients had at least one adverse event in masitinib arm versus 99.3% in the control arm
• 18.7% of patients had one fatal adverse event in masitinib arm versus 19.1% in the control arm
• 19.1% of patients had at least one serious adverse event (non-fatal) in masitinib arm versus 21.3% in the control arm
• 74.8% of patients had at least one adverse event with Grade 3 or 4 in masitinib arm versus 83.1% in the control arm

Study AB12005 was a confirmatory Phase 3 study. The first Phase 3 study (AB07012) was a hypothesis generating study and identified that patients with pain had a median OS increased by 2.6 months (p=0.012) with masitinib as compared to control. Study AB12005 demonstrated that there is a benefit generated by masitinib for pancreatic cancer patients with pain, provided that treatment is initiated prior to metastasis.

Dr. Joël Ezenfis, MD, principal coordinating investigator of the study, said: “We are very pleased that this study is successful. The increase of 1.8 months in median overall survival for masitinib-treated patients is clinically relevant as this population of patients suffers from a condition with very limited treatment options and survival rate has remained stubbornly poor despite decades of clinical studies.”

Julien Taieb, MD, PhD, Head of the Gastroenterology and Gastrointestinal Oncology Department at the Georges Pompidou European Hospital said: “Masitinib is not a cytotoxic agent but a targeted drug blocking two cells of the innate immune system, mast cells and macrophages. Study AB12005 demonstrated for the first time that this targeted approach is beneficial in a targeted population, made of patients with unresectable locally advanced tumors with pain”.