FDA Approves New First-Line Treatment for Pancreatic Adenocarcinoma

Adding to existing pancreatic cancer treatment options, the United States FDA granted Ipsen Biopharmaceuticals approval for Onivyde — generically known as irinotecan liposome — for treating metastatic pancreatic adenocarcinoma. The drug is intended for use alongside other chemotherapy drugs, including oxaliplatin, fluorouracil, and leucovorin.

The FDA approval announcement revealed that the administration based its conclusions on multiple factors, including a randomized, multicenter, open-label, active-controlled clinical trial called NAPOLI3.

NAPOLI3 recruited 770 metastatic pancreatic adenocarcinoma patients who had not undergone any chemotherapy for their metastatic disease. Patients were randomized to one of two treatment protocols in stratified groups based on region, liver metastases, and Eastern Cooperative Oncology Group (ECOG) performance status.

The first protocol, NALRIFOX, included a 50 mg/m2 intravenous infusion of irinotecan liposome over 90 minutes. The first infusion is followed by 60 mg/m2 of oxaliplatin over 120 minutes, 400 mg/m2 of leucovorin over 30 minutes, and 2400 mg/m2 of fluorouracil over 46 hours. The protocol was delivered every two weeks.

The other protocol was the active control, which included 125 mg/m2 of Nab-paclitaxel over 35 minutes and 1000 mg/m2 of gemcitabine over 30 minutes. This protocol was delivered on days 1, 18, and 15 of each 28-day cycle.

Based on the overall survival, investigator-assessed progression-free survival, and objective response rate, the NALRIFOX treatment protocol was superior to the active control.

The median overall survival for the NALRIFOX group was 11.1 months, while the overall survival for the active control was roughly 9.2 months. Additionally, the progression-free survival was more significant in the NALRIFOX group, with 7.4 months, compared to 5.6 months in the active control group. Finally, the objective response rate was 41.8% in the experimental group, compared to 36.2% in the control group.

Additionally, the study results identified that the most common adverse reactions included diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation, and weight loss.

According to the American Cancer Society, pancreatic adenocarcinoma occurs when pancreatic exocrine cells grow uncontrollably. The condition often arises in the pancreatic ducts. The organization notes that approximately 66,440 people in the US will be diagnosed with pancreatic cancer in 2024, accounting for roughly 3% of all cancer cases domestically. Additionally, 51,750 people will die of pancreatic cancer this year, representing 7% of all cancer deaths.

Considering the high mortality rate associated with this type of cancer, having additional treatment options may offer better outcomes.