Zachary Bessette

GI Oncology Now

The <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-irinotecan-liposome-first-line-treatment-metastatic-pancreatic-adenocarcinoma" target="_blank" rel="noopener">US Food and Drug Administration (FDA) has granted approval to irinotecan liposome</a> (Onivyde, Ipsen Biopharmaceuticals) in combination with oxaliplatin, fluorouracil, and leucovorin for the first-line treatment of metastatic pancreatic adenocarcinoma.Approval comes as a result of the NAPOLI 3 study, which demonstrated improved overall survival (OS) and progression-free survival (PFS) of irinotecan liposome over gemcitabine plus nab-paclitaxel in patients with metastatic pancreatic adenocarcinoma who had not previously received chemotherapy in the metastatic setting. The randomized, multicenter, open-label, active-controlled study included 770 patients, randomized (1:1) by region, liver metastases, and Eastern Cooperative Oncology Group performance status.Patients were randomized to either the NALIRIFOX arm (irinotecan liposome [50 mg/m2] as an intravenous infusion over 90 minutes, followed by oxaliplatin [60 mg/m2] as an intravenous infusion over 120 minutes, followed by leucovorin [400 mg/m2] intravenously over 30 minutes, followed by fluorouracil [2400 mg/m2] intravenously over 46 hours every 2 weeks) or the Gem+NabP arm (nab-paclitaxel [125 mg/m2] as an intravenous infusion over 35 minutes, followed by gemcitabine [1000 mg/m2] intravenously over 30 minutes on days 1, 8, and 15 of each 28-day cycle).Results of NAPOLI 3 showed a statistically significant improvement in OS (11.1 vs 9.2 months) and PFS (7.4 vs 5.6 months) for the NALIRIFOX arm over the Gem+NabP arm, respectively.Additionally, objective response rates were 41.8% versus 36.2%, respectively.The most common adverse events with NALIRIFOX, which occurred in at least 20% of patients in the trial, were diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation, and decreased weight. The most common laboratory abnormalities, which occurred in at least 10% of patients in the trial, were decreased neutrophils, potassium, lymphocyte, and hemoglobin.The FDA noted that the recommended irinotecan liposome dose is 50 mg/m2 administered by intravenous infusion over 90 minutes every 2 weeks. Irinotecan liposome is also to be administered before oxaliplatin, fluorouracil, and leucovorin.

Emily Menendez

DYNAMIC Study 5-Year Outcomes Provide OS and ctDNA Insight

Colorectal Cancer

Jessica Ganga

Characteristics of Esophageal Gastrointestinal Stromal Tumors, Feasibility for Endoscopic Resection

GIST

Samuel Cytryn, MD

ctDNA-Guided Immunotherapy: A New Era of Gastric Cancer Recurrence Prevention

Gastric Cancer

Latest News

FDA Approves New First-line Treatment for Metastatic Pancreatic Adenocarcinoma

Pancreatic Cancer

The NAPOLI 3 study demonstrated improved OS and PFS in patients with metastatic pancreatic cancer and no prior chemotherapy.