Ipsen Presents Phase III NAPOLI 3 Trial of Onivyde(R) Regimen Demonstrating Positive Survival Results in Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma At Asco GI

Ipsen announced positive results from the pivotal Phase III NAPOLI 3 trial evaluating an investigational regimen of Onivyde® (irinotecan liposome injection), a long-circulating, liposomal topoisomerase inhibitor, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). In a late-breaking abstracts session presentation (LBA661) at the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, the data demonstrating investigational novel NALIRIFOX regimen (liposomal irinotecan 50 mg/m2 + 5-FU 2400 mg/m2 + leucovorin 400 mg/m2 + oxaliplatin 60 mg/m2) improved overall survival (OS) and progression-free survival (PFS) compared to nab-paclitaxel plus gemcitabine. At the median follow-up of 16.1 months, the investigational Onivyde regimen met its primary endpoint demonstrating a statistically significant improvement in OS of 11.1 months compared to 9.2 months for patients treated with nab-paclitaxel and gemcitabine (HR 0.83 [95% CI 0.70–0.99]; p=0.04).

NAPOLI 3 secondary outcome measures included PFS, objective response rate (ORR), incidence of treatment-emergent adverse events, serious adverse events, and laboratory abnormalities. Trial met its secondary endpoint showing patients treated with NALIRIFOX had a statistically significant improvement in median PFS of 7.4 months versus 5.6 months for nab-paclitaxel and gemcitabine (HR 0.69 [95% CI 0.58–0.83]; p=0.0001); ORR was 41.8% (36.8%-46.9%; 95% CI) for patients treated with the NALIRIFOX regimen versus 36.2% (31.4%-41.2%; 95% CI) for patients treated with nab-paclitaxel and gemcitabine; The safety profile of NALIRIFOX was manageable and consistent with the profiles of the treatment components. The most common grade 3/4 treatment-emergent adverse events (TEAEs) with more than 10% frequency in patients receiving NALIRIFOX versus nab-paclitaxel and gemcitabine included diarrhea (20.3% versus 4.5%), nausea (11.9% versus 2.6%), hypokalemia (15.1% versus 4.0%), anemia (10.5% versus 17.4%) and neutropenia (14.1% versus 24.5%).