The combination of liposomal irinotecan, 5-fluorouracil, leucovorin, and oxaliplatin (NALIRIFOX) can improve survival, when compared with gemcitabine plus nab-paclitaxel, in patients with previously untreated, metastatic pancreatic ductal adenocarcinoma (PDAC), according to research presented at the ASCO Annual Meeting 2023.
Both overall survival (OS) and progression-free survival (PFS) were improved with NALIRIFOX, and toxicity was manageable, according to study presenter Eileen Mary O’Reilly, MD, of Memorial Sloan Kettering Cancer Center in New York, New York.
These results come from the phase 3 NAPOLI 3 trial (ClinicalTrials.gov Identifier: NCT04083235). The trial included 770 treatment-naïve patients with metastatic PDAC. They were randomly assigned to treatment in 28-day cycles with either NALIRIFOX (n=383) or gemcitabine plus nab-paclitaxel (n=387).
The median follow-up was 16.1 months. The objective response rate was 41.8% in the NALIRIFOX arm and 36.2% in the gemcitabine/nab-paclitaxel arm. The proportion of patients who received subsequent anticancer therapy was 50.5% in the NALIRIFOX arm and 54.4% in the gemcitabine/nab-paclitaxel arm.
The median OS was 11.1 months in the NALIRIFOX arm and 9.2 months in the gemcitabine/nab-paclitaxel arm (hazard ratio [HR], 0.83; 95% CI, 0.70-0.99; P =.04).
The 12-month OS rate was 45.6% in the NALIRIFOX arm and 39.5% in the gemcitabine/nab-paclitaxel arm. The 18-month OS rates were 26.2% and 19.3%, respectively.
The median PFS was 7.4 months in the NALIRIFOX arm and 5.6 months in the gemcitabine/nab-paclitaxel arm (HR, 0.69; 95% CI, 0.58-0.83; P <.0001).
The 12-month PFS rate was 27.4% in the NALIRIFOX arm and 13.9% in the gemcitabine/nab-paclitaxel arm. The 18-month PFS rates were 11.4% and 3.6%, respectively.
Serious treatment-emergent adverse events (TEAEs) were reported in 54.3% of patients in the NALIRIFOX arm and 51.5% of those in the gemcitabine/nab-paclitaxel arm. Grade 3 or higher TEAEs were reported in 87.0% and 86.0%, respectively. TEAEs leading to death were reported in 5.9% of patients in the NALIRIFOX arm and 6.1% of those in the gemcitabine/nab-paclitaxel arm.
These results support NALIRIFOX as a reference regimen for first-line treatment of metastatic pancreatic cancer, Dr O’Reilly concluded.
Disclosures: This research was supported by Ipsen. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
O’Reilly EM, Melisi D, Macarulla T, et al. Liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): 12- and 18-month survival rates from the phase 3 NAPOLI 3. ASCO 2023. June 2-6, 2023. Abstract 4006.