{"id":36269,"date":"2019-09-08T09:00:00","date_gmt":"2019-09-08T07:00:00","guid":{"rendered":"https:\/\/www.ipsen.com\/press-releases\/ipsen-and-servier-announce-initial-phase-ii-iii-clinical-data-evaluating-investigational-liposomal-irinotecan-onivyde-as-a-second-line-treatment-for-small-cell-lung-cancer-sclc-at-the-iaslc\/"},"modified":"2024-07-25T09:04:03","modified_gmt":"2024-07-25T07:04:03","slug":"ipsen-and-servier-announce-initial-phase-ii-iii-clinical-data-evaluating-investigational-liposomal-irinotecan-onivyde-as-a-second-line-treatment-for-small-cell-lung-cancer-sclc-at-the-iaslc","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/press-releases\/ipsen-and-servier-announce-initial-phase-ii-iii-clinical-data-evaluating-investigational-liposomal-irinotecan-onivyde-as-a-second-line-treatment-for-small-cell-lung-cancer-sclc-at-the-iaslc\/","title":{"rendered":"Ipsen and Servier announce initial Phase II\/III clinical data evaluating investigational liposomal irinotecan (ONIVYDE\u00ae) as a second-line treatment for small cell lung cancer (SCLC) at the IASLC 2019 World Conference on Lung Cancer"},"content":{"rendered":"

<\/p>\n

\u2013 44% of patients achieved a response and nearly half (48%) maintained disease control at week 12 (efficacy as secondary endpoint) \u2013<\/b>
\u2013 Treatment emergent adverse events Grade 3 or higher were reported by 10 of 25 patients (safety as primary endpoint) \u2013<\/b><\/p>\n

Paris (France), 8 September 2019<\/b>\u00a0\u2013\u00a0Ipsen<\/u><\/b><\/a>\u00a0(Euronext: IPN; ADR: IPSEY) and\u00a0Servier<\/u><\/b><\/a>\u00a0announced today initial safety and efficacy data from Part 1 of the Phase II\/III RESILIENT study of investigational liposomal irinotecan (ONIVYDE\u00ae) in patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen. 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.<\/p>\n

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 (PFS) and overall survival (OS).<\/p>\n

\n

\u201cImmunotherapies and combination therapies have proven beneficial in the first-line setting, but despite these advances, many small cell lung cancer patients rapidly relapse due to the aggressive nature of the disease,\u201d said Luis G. Paz-Ares, M.D., Ph.D., lead investigator and chief physician, Hospital Universitario 12 de Octubre, Madrid. \u201cWhile the current standard of care in the second-line setting can extend survival, treatment toxicity has prevented some patients from receiving the full recommended dose. There is a clear need for more treatment options that may give more patients the chance to remain on therapy. It is positive that the RESILIENT trial will continue to investigate this.\u201d<\/p>\n<\/blockquote>\n

ONIVYDE\u00ae\u00a0(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 U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval of ONIVYDE\u00ae\u00a0in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy. ONIVYDE\u00ae\u00a0is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.<\/p>\n

\n

\u201cONIVYDE\u00ae\u00a0has been proven to help many metastatic pancreatic cancer patients whose disease has progressed following gemcitabine-based therapy to live longer,\u201d said Yan Moore, M.D., Ipsen\u2019s Senior Vice President, Head of Oncology Therapeutic Area. \u201cBy applying this research to other hard-to-treat-cancers, like small cell lung cancer, we aim to evaluate the potential benefit investigational ONIVYDE\u00ae\u00a0may bring to patients who otherwise would have limited treatment options.\u201d<\/p>\n<\/blockquote>\n

<\/p>\n

\n

\u201cThe data presented today shows that further research is warranted, and we look forward to working with Ipsen and our investigators to understand the full potential of bringing new treatment options to small cell lung cancer patients,\u201d said Patrick Therasse, M.D., Ph.D., Head of Servier Research and Development Oncology.<\/p>\n<\/blockquote>\n

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.<\/p>\n

Safety Results:<\/b><\/p>\n