NALLONG study: Characterising long-term survivors treated with nal-IRI in mPDA

Prof Jean-Luc Van Laethem, principal investigator of the NALLONG study, shared the data presented at ESMO GI. NALLONG is a retrospective, multinational study aimed to characterise real-world long-term survivors with mPDAC who had received nal-IRI, and to identify prognostic factors associated with extended survival outcomes. 

The study was conducted across five countries in Europe and Asia and focused on patients who survived at least one year following nal-IRI exposure. A total of 163 patients were included, with primary endpoints of PFS and OS. Subgroup analyses were performed based on clinical characteristics, including prior surgery, prior exposure to conventional irinotecan, and the presence of exceptional responders. Exceptional responders were defined as patients with a PFS ratio of ≥2.8 when comparing nal-IRI to their previous line of therapy—a threshold derived from the mean PFS ratio observed in the NALLONG cohort.

Most patients received nal-IRI in the second-line setting, with a smaller proportion treated in third-line. In the overall population, the median OS from the time of diagnosis was 34 months, while the OS from nal-IRI initiation was 21 months. Median PFS following nal-IRI treatment was 12 months. Among patients previously exposed to conventional irinotecan, OS from nal-IRI initiation was 15 months, with a PFS of 9 months. Notably, in the subgroup of exceptional responders—approximately one-third of the total cohort—OS reached 27 months with a median PFS of 17 months post-nal-IRI. Outcomes for patients with a history of surgery were similar to those in the general study population.

Analysis of prognostic factors revealed several clinically relevant associations. The presence of liver metastases was identified as a negative prognostic marker. In contrast, prior surgical resection and prior radiotherapy were associated with improved survival outcomes. Importantly, dose adaptation of the nal-IRI regimen—allowing for better tolerability and extended treatment duration—was associated with improved prognosis, suggesting that individualised treatment adjustments may confer benefit in selected patients.

In conclusion, the NALLONG study highlights that a subset of patients with mPDAC can achieve prolonged survival with nal-IRI, particularly when dose optimisation strategies are applied. These findings offer valuable insights for tailoring therapy in real-world clinical practice and underscore the importance of personalised treatment approaches in this challenging disease.