P48.14 RESILIENT Part 2: A phase 3 Study of Liposomal Irinotecan in Patients with Small-Cell Lung Cancer in the Second-Line Setting

Abstract

Introduction: Small cell lung cancer (SCLC) accounts for approximately 15% of lung cancers. SCLC is usually sensitive to established first-line therapies, but many patients relapse and develop resistance to platinum-based first-line treatment. Currently, the topoisomerase 1 inhibitor topotecan is the only approved second-line therapy for SCLC in the USA and Europe. Liposomal irinotecan is an intravenous formulation that encapsulates the topoisomerase 1 inhibitor irinotecan in a lipid-bilayer vesicle, leading to prolonged circulation. The safety, tolerability and efficacy of liposomal irinotecan monotherapy in patients with SCLC who progressed with platinum-based first-line therapy is being evaluated in RESILIENT (NCT03088813), a two-part phase 2/3 study. Preliminary data from the dose-ranging part of the study (part 1) indicated that liposomal irinotecan 70 mg/m2 (free base equivalent) administered every 2 weeks was well tolerated and had promising antitumour activity.1 Here, we present the design of RESILIENT part 2, which will assess the efficacy and safety of liposomal irinotecan versus topotecan in the same patient population. References: Paz-Ares L et al. Poster presented at the 2019 American Society of Clinical Oncology conference, May 31-June 4, 2019, Chicago, IL, USA. Method(s): RESILIENT part 2 is a phase 3, open-label study with a planned sample size of 450. Participants are randomized 1:1 to intravenous liposomal irinotecan or intravenous topotecan. Liposomal irinotecan is administered at 70 mg/m2 every 2 weeks and topotecan is administered at 1.5 mg/m2 for 5 consecutive days every 3 weeks. A total of 254 patients have been randomized and received treatment to date (as of August 8, 2020). Tumour 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. Improvements in symptoms are measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13. Safety assessments include monitoring for adverse events. Overall survival is the primary endpoint of the study. Progression-free survival, objective response rate and proportion of patients reporting symptom improvement are secondary endpoints. Participants will continue study treatment until disease progression, unacceptable toxicity or study withdrawal. Participants will be followed for survival until death or study end, which is when all patients have died, withdrawn consent or are lost to follow-up. Result(s): Conclusion Keywords: liposomal irinotecan, small-cell lung cancer, RESILIENTCopyright © 2021