9 July 2019 - - French drugmaker Ipsen (Euronext: IPN) (OTC: IPSEY) and Servier have presented 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 in study patients with previously untreated metastatic pancreatic ductal adenocarcinoma cancer at the ESMO 21st World Congress on Gastrointestinal Cancer in Barcelona, Spain, 3–6 July 2019, the companies said.
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.
Onivyde is a topoisomerase inhibitor indicated in combination with 5-FU/LV for metastatic pancreatic cancer after disease progression following gemcitabine-based therapy.
The ongoing Phase 1/2, open-label trial (NCT02551991) was designed to assess the safety, tolerability and dose-limiting toxicities of the study drug, liposomal irinotecan, in combination with 5-FU/LV and OX, known as Napox, for the first-line treatment of study participants with metastatic pancreatic cancer.
Secondary objectives were to assess clinical efficacy, defined by overall response rate, disease control rate and best overall response.
Preliminary analyses of median progression-free survival and median overall survival were not mature enough for evaluation.
As of the 19 February 2019 data cut off, a total of 56 study patients (median age = 58 (39-76) years) were enrolled and dosed at 15 sites across the US, Spain and Australia.
The interim analysis was conducted after all study participants in the four dose exploration cohorts had completed their second scheduled tumor evaluation at 16 weeks.
Study participants from the Part 1A–cohort B dose exploration phase and study participants from the Part 1B–dose expansion phase received the selected dose level of liposomal irinotecan 50 mg/m2 [free-base equivalent; FBE], LV 400 mg/m2, 5-FU 2400 mg/m2, and OX 60 mg/m2. These 32 patients made up the pooled population analysis (n=29 mPDAC; n=3 locally advanced pancreatic PDAC).
Onivyde is an encapsulated formulation of irinotecan available as a 43 mg/10 mL single dose vial. This liposomal form is designed to increase length of tumor exposure to both irinotecan and its active metabolite, SN-38.
Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the US. Servier is responsible for the development and commercialization of Onivyde outside of the US and Taiwan under an exclusive licensing agreement with Ipsen.
Onivyde is approved by the FDA and the EMA in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Limitation of Use: Onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.