- At the primary analysis, the trial did not meet its primary endpoint of overall survival (OS)
- The safety profile was consistent with previously reported studies of Onivyde® (irinotecan liposomal injection)
- The clinical study results will be communicated with the regulatory agency
PARIS, France I August 03, 2022 I Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Phase III RESILIENT trial did not meet its primary endpoint of overall survival (OS) compared to topotecan. The trial is evaluating Onivyde® (irinotecan liposomal injection) versus topotecan in patients with small cell lung cancer (SCLC), who have progressed on or after platinum-based first-line therapy treatment. RESILIENT is a Phase III trial conducted in two parts; the first part read out in 2020 confirming the safety, dosing and efficacy of Onivyde; part two is evaluating the efficacy of Onivyde versus topotecan. Detailed results from the RESILIENT trial will be presented at an upcoming medical conference.
The analysis concluded that the primary endpoint OS was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate (ORR) in favor of Onivyde was observed. The safety and tolerability of Onivyde was consistent with its already-known safety profile, and no new safety concerns emerged. The clinical study results will be communicated with the regulatory agency.
Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen, said: “While the results from the analysis of the RESILIENT trial have not demonstrated an overall survival benefit with Onivyde in patients in second-line small cell lung cancer, we will now work with our teams to analyze the data further before decisions regarding next steps are made. These data confirm the complexities associated with treating small cell lung cancer. We wish to thank the patients, their families and healthcare teams for their participation in this clinical trial.”
Onivyde is currently approved in most major markets including the U.S., Europe and Asia in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas. Ipsen will continue to explore the potential of Onivyde in other areas, and the final data readout of the NAPOLI-3 Phase III trial in first-line pancreatic ductal adenocarcinoma is expected in H2 2022.
ENDS
About RESILIENT
RESILIENT is a randomized, open-label Phase III trial of Onivyde (irinotecan liposome injection) versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy. The trial is being conducted in two parts:
- Part 1: Open-label dose-finding trial of Onivyde. 30 patients were enrolled.
- Part 1 Primary endpoints:
- Describe the safety and tolerability of Onivyde monotherapy administered every 2 weeks
- Determine the optimal Onivyde monotherapy dose for Part 2 of this trial
- Part 2: A randomized, efficacy study of Onviyde versus intravenous (IV) topotecan. Approximately 450 patients were enrolled in part 2.
Part 2 objectives: To compare overall survival (OS) following treatment with Onivyde with OS following treatment with IV topotecan
The primary outcome measure is OS. Secondary outcome measures include progression-free survival, objective response rate, quality of life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-C30/LC13) dyspnea scale, quality of life assessment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) cough scale, incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities. Safety analyses (adverse events and laboratory analyses) will be performed using the safety population, defined as all patients receiving any trial medicine.
About Onivyde (irinotecan liposome injection)
Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the U.S. Servier, an independent international pharmaceutical company with a strong international presence in 150 countries, is responsible for the commercialization of Onivyde outside of the U.S. and Taiwan. PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of Onivyde in Taiwan.
Indication – U.S.
Onivyde is approved by the U.S. FDA in combination with fluorouracil (5-FU) and leucovorin (LV) 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.
Please see full U.S. Prescribing Information including Boxed WARNING for Onivyde.
About Ipsen
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With Specialty Care sales of €2.6bn in FY 2021, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen, excluding its Consumer HealthCare business, has around 4,500 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com
SOURCE: Ipsen
Post Views: 56
- At the primary analysis, the trial did not meet its primary endpoint of overall survival (OS)
- The safety profile was consistent with previously reported studies of Onivyde® (irinotecan liposomal injection)
- The clinical study results will be communicated with the regulatory agency
PARIS, France I August 03, 2022 I Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Phase III RESILIENT trial did not meet its primary endpoint of overall survival (OS) compared to topotecan. The trial is evaluating Onivyde® (irinotecan liposomal injection) versus topotecan in patients with small cell lung cancer (SCLC), who have progressed on or after platinum-based first-line therapy treatment. RESILIENT is a Phase III trial conducted in two parts; the first part read out in 2020 confirming the safety, dosing and efficacy of Onivyde; part two is evaluating the efficacy of Onivyde versus topotecan. Detailed results from the RESILIENT trial will be presented at an upcoming medical conference.
The analysis concluded that the primary endpoint OS was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate (ORR) in favor of Onivyde was observed. The safety and tolerability of Onivyde was consistent with its already-known safety profile, and no new safety concerns emerged. The clinical study results will be communicated with the regulatory agency.
Howard Mayer, M.D., Executive Vice President, Head of Research and Development at Ipsen, said: “While the results from the analysis of the RESILIENT trial have not demonstrated an overall survival benefit with Onivyde in patients in second-line small cell lung cancer, we will now work with our teams to analyze the data further before decisions regarding next steps are made. These data confirm the complexities associated with treating small cell lung cancer. We wish to thank the patients, their families and healthcare teams for their participation in this clinical trial.”
Onivyde is currently approved in most major markets including the U.S., Europe and Asia in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas. Ipsen will continue to explore the potential of Onivyde in other areas, and the final data readout of the NAPOLI-3 Phase III trial in first-line pancreatic ductal adenocarcinoma is expected in H2 2022.
ENDS
About RESILIENT
RESILIENT is a randomized, open-label Phase III trial of Onivyde (irinotecan liposome injection) versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy. The trial is being conducted in two parts:
- Part 1: Open-label dose-finding trial of Onivyde. 30 patients were enrolled.
- Part 1 Primary endpoints:
- Describe the safety and tolerability of Onivyde monotherapy administered every 2 weeks
- Determine the optimal Onivyde monotherapy dose for Part 2 of this trial
- Part 2: A randomized, efficacy study of Onviyde versus intravenous (IV) topotecan. Approximately 450 patients were enrolled in part 2.
Part 2 objectives: To compare overall survival (OS) following treatment with Onivyde with OS following treatment with IV topotecan
The primary outcome measure is OS. Secondary outcome measures include progression-free survival, objective response rate, quality of life assessment using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-C30/LC13) dyspnea scale, quality of life assessment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) cough scale, incidence of treatment-emergent adverse events, serious adverse events and laboratory abnormalities. Safety analyses (adverse events and laboratory analyses) will be performed using the safety population, defined as all patients receiving any trial medicine.
About Onivyde (irinotecan liposome injection)
Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the U.S. Servier, an independent international pharmaceutical company with a strong international presence in 150 countries, is responsible for the commercialization of Onivyde outside of the U.S. and Taiwan. PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of Onivyde in Taiwan.
Indication – U.S.
Onivyde is approved by the U.S. FDA in combination with fluorouracil (5-FU) and leucovorin (LV) 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.
Please see full U.S. Prescribing Information including Boxed WARNING for Onivyde.
About Ipsen
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With Specialty Care sales of €2.6bn in FY 2021, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen, excluding its Consumer HealthCare business, has around 4,500 colleagues worldwide and is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com
SOURCE: Ipsen
Post Views: 56
