Irinotecan liposome injection is currently approved in the United States and Europe 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. This agent is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas. The approval for small cell lung cancer was based upon an ongoing phase III randomized study (the RESILIANT trial).
The use of this agent is being assessed in comparison with topotecan in an estimated 480 patients. The goal of the study is to assess the efficacy and safety of irinotecan liposome injection as monotherapy for patients with SCLC who have progressed on or after a first-line platinum-based regimen. The primary endpoint of the RESILIENT trial is overall survival, and the secondary endpoints include progression-free survival, objective response, percentage of patients with symptom improvement, and the prevalence of treatment-emergent adverse events. Patients are required to be at least age 18 years with an Eastern Cooperative Oncology Group performance status of zero or one, have a life expectancy of at least 12 weeks, histologically or cytologically confirmed SCLC, and evaluable disease per RECIST v1.1 criteria.
Patients are also required to have radiologically confirmed progression on or after first-line platinum-based chemotherapy, immunotherapy, or chemoradiation, as well as adequate bone marrow, hepatic function, and renal function. Patients with central nervous system metastases were permitted into the study given they met certain criteria.
In the press release, Howard Mayer, MD, executive vice president, head of research and development at Ipsen, stated, “The Fast Track designation of Onivyde as a potential treatment for people living with small cell lung cancer is an extension of Ipsen’s focus and contribution to the treatment landscape in oncology. With this aggressive and often late-stage diagnosed form of lung cancer, we are proud to be one step closer to making another treatment option available to patients.”
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