Research & Development
Ipsen and Servier Present Initial Phase II/III Clinical Data Evaluating Investigational Liposomal Irinotecan (Onivyde) as a Second-Line Treatment for Small Cell Lung Cancer
9 September 2019 - - French pharmaceutical company Ipsen (Euronext: IPN) (OTC: IPSEY) and pharmaceutical company Servier have presented initial safety and efficacy data from Part 1 of the Phase II/III RESILIENT study of investigational liposomal irinotecan (ONIVYDE) in patients with small cell lung cancer who progressed following a first-line platinum-based regimen, the companies said.

The results, which included preliminary safety and efficacy data, were presented as an oral presentation at the IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, 7-10 September 2019.

The RESILIENT (NCT03088813) trial is a randomized, open-label two-part Phase II/III study assessing the safety, tolerability and efficacy of investigational liposomal irinotecan as a monotherapy for SCLC patients who have progressed on or after a first-line platinum-based regimen. The trial is being conducted in two parts.

Part 1 includes dose-finding and dose-escalation analyses to determine the appropriate dose of study drug where the primary endpoints are safety and tolerability.

Part 2 has just been initiated with the first patients randomized and will focus on efficacy assessments versus the current standard of care, topotecan, including progression-free survival and overall survival.

ONIVYDE (liposomal irinotecan) is a topoisomerase inhibitor featuring a liposomal formulation of irinotecan that is designed to prolong its circulation before conversion to its active form.

This unique mechanism of delivery was evaluated in the NAPOLI-1 Phase III study, which led to the US Food and Drug Administration and European Medicines Agency approval of Onivyde in combination with fluorouracil and leucovorin for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.

Onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

Part 1 of the study enrolled 30 patients (median age = 60 (48-73) years) who were treated every two weeks for >12 weeks, with tumor assessments taking place every six weeks.

During the dose-finding phase, five patients received liposomal irinotecan 85mg/m2. This dose was deemed not tolerable due to dose limiting toxicity.

An additional 12 patients received liposomal irinotecan 70mg/m2, which was deemed tolerable.

Thirteen more patients were enrolled in the dose expansion phase of the study at this dose. As of the May 8, 2019 data cut off, a total of 25 patients had received liposomal irinotecan 70mg/m2.

The Phase II/III, randomized, open-label, RESILIENT study is designed to assess the safety, tolerability and efficacy of investigational Onivyde versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy. The study is enrolling up to 486 patients at 34 sites across the United States, Spain, Germany, France, Taiwan and Australia.

The study's primary endpoint is overall survival defined as the time from randomization to date of death. Secondary assessments include progression-free survival, objective response rate, proportion of patients with symptom improvement and incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities.

The rate of development of CNS metastases, and biomarkers associated with efficacy and toxicity will be explored. For more information visit clinicaltrials.gov and use identifier NCT03088813.
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