Ipsen announces preliminary data from Phase 1/2 pancreatic cancer study
Ipsen (IPSEY) and Servier announced preliminary data from the Phase 1/2 study of the investigational use of liposomal irinotecan in combination with 5- fluorouracil/leucovorin and oxaliplatin in study patients with previously untreated metastatic pancreatic ductal adenocarcinoma cancer. The results, which were presented as a short oral presentation, included preliminary safety and efficacy data from an ongoing multicenter, open-label, dose-escalation study, which aims to determine the maximum tolerated dose and the recommended dose to be used in future clinical studies. As of the February 19 data cut off, a total of 56 study patients were enrolled and dosed at 15 sites across the US, Spain and Australia. Best overall response) was one complete response, 10 partial responses in 31.3% and 15 stable diseases in 46.9%. 71.9% of study patients in the 50/60 PP achieved disease control at 16 weeks, added the company. Overall, 34% of study patients had a response. Further, there we no reported Grade 3 or higher fatigue or peripheral neuropathy. One study participant in the Part 1A-cohort B dose exploration phase reported a febrile neutropenia. Treatment emergent adverse events Grade 3 or higher were reported by 20 of 32 patients in the 50/60 PP. At data cut-off, 15/32 study patients in the 50/60 PP remained on treatment.