ONIVYDE® for 2L SCLC Phase III trial Did Not Meet Primary Endpoint
ONIVYDE® Showed a Favorable Safety and Tolerability Profile among Study Participants that was Consistent with Prior Clinical Trial Results
The clinical study results will be communicated with the regulatory agency by IPSEN
PharmaEngine’s corporate partner, IPSEN. (Euronext: IPN; ADR: IPSEY) has announced results from the RESILIENT Phase 3 multicenter, randomized, controlled study evaluating ONIVYDE® as a single agent for the treatment of small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen.
RESILIENT is a phase 3, open-label study with a planned sample size of 450. Patients are randomly allocated 1:1 to intravenous ONIVYDE® or intravenous topotecan. ONIVYDE® is administered every 2 weeks at 70 mg/m2 (free-base equivalent) and topotecan is administered for 5 consecutive days every 3 weeks at 1.5 mg/m2. Tumor assessments are performed using the Response Evaluation Criteria in Solid Tumors version 1.1 and the Response Assessment in Neuro-oncology criteria for CNS lesions; symptom improvement is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Safety assessments include monitoring for adverse events.
The study did not meet the the primary endpoint of overall survival (OS) in patients with SCLC comparing ONIVYDE® to the control arm, though there was no adverse effect on OS with the experimental arm. Based on the study design, analyses of the secondary endpoint of objective response rate (ORR) favored the ONIVYDE® arm.
The safety data in this study was consistent with the Part I of RESILIENT trial with no new safety signals observed. The experimental arm showed favorable safety and tolerability regarding Grade-3 or greater drug related adverse events (AEs), deaths due to AEs, hematologic toxicity, dose reductions and treatment discontinuations due to AEs, compared to the control arm.
Results will be discussed with the appropriate regulatory authorities and will be presented at a future medical meeting. For further information regarding IPSEN’s press release, please refer to the following link：https://www.ipsen.com/news-center/press-releases/
About RESILIENT trial
This study will take place in 2 parts (Part 1 and Part 2). The purpose of Part 1 was to find out the best dose of irinotecan liposome injection to be used in Part 2 of the study. Once the best dose was found, Part 1 closed to enrollment and Part 2 opened. The purpose of Part 2 is to see how effective and safe the study drug is at treating subjects with small cell lung cancer. This will be done by comparing the effects of the study drug with the effects of topotecan. Topotecan is approved for the treatment of small cell lung cancer. For additional information, please visit www.clinicaltrials.gov. (Clinical trial information: NCT03088813.).
About ONIVYDE®
ONIVYDE®, also known as nal-IRI, MM-398 or PEP02, is a novel encapsulation of irinotecan in a liposomal formulation. PharmaEngine, Inc. has Taiwan exclusive commercial rights, Ipsen (Euronext: IPN; ADR: IPSEY) acquired the US exclusive new indication development and commercial rights, the exclusive rights for rest of the world are owned by Servier. ONIVYDE® has received marketing authorizations more than 40 countries worldwide, including Taiwan, US, EU, Australia, Canada, Japan, South Korea, Singapore and China since 2011. It also received orphan drug designations in the US, EU, and other countries.
About Small Cell Lung Cancer (SCLC)
Small cell lung cancer is a disease in which malignant cells form in the tissues of the lung. There are two main types of small cell lung cancer. Smoking is the major risk factor for small cell lung cancer. Signs and symptoms of small cell lung cancer include coughing and shortness of breath. Around 15% to 20% of lung cancers are small cell, and it is one of the cancer types with the worst prognosis.
About PharmaEngine, Inc. (TWO: 4162)
PharmaEngine, Inc. is a commercial stage oncology company headquartered in Taipei, focusing on the development of new medications for the treatment of cancer. PharmaEngine, Inc. has two ongoing projects: ONIVYDE® has received marketing authorizations more than 40 countries worldwide, including Taiwan, US, EU, Australia, Canada, Japan, South Korea, Singapore and China, for the treatment of metastatic pancreatic cancer patients who have progressed on gemcitabine; PEP07, a CHK1 inhibitor, is under development at pre-clinical stage. For further information, please visit the company website (https://www.pharmaengine.com)