Ipsen, Servier Phase 1/2 Pancreatic Cancer Data at ESMO GI Cancer Meet

• Treatment emergent adverse events Grade 3 or higher were reported by 20 of 32 patients from the 50/60 dose pooled patient analysis; no patient reported Grade 3 or higher fatigue or peripheral neuropathy (primary endpoint)
• Approximately three quarters of patients (71.9%) achieved disease control at week 16, while 34% had a response (secondary endpoint)

Ipsen (Euronext: IPN; ADR: IPSEY) and Servier announced today preliminary data from the Phase 1/2 study of the investigational use of liposomal irinotecan (ONIVYDE^®) in combination with 5- fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) in study patients with previously untreated metastatic pancreatic ductal adenocarcinoma cancer (PDAC) at the ESMO 21^st World Congress on Gastrointestinal Cancer in Barcelona, Spain, 3–6 July 2019. 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.

https://www.biospace.com/article/releases/ipsen-and-servier-announce-initial-phase-1-2-clinical-data-evaluating-liposomal-irinotecan-onivyde-as-an-investigational-first-line-treatment-for-metastatic-pancreatic-cancer-at-esmo-21st-world-congress-on-gastrointestinal-cancer/