Adding a liposomal formulation of irinotecan to 5-fluorouracil (5-FU) and leucovorin (LV) can improve outcomes in patients with gemcitabine-refractory advanced pancreatic cancer, according to phase 3 results presented at ESMO Congress 2022.
Researchers found that HR070803, the liposomal irinotecan, improved progression-free survival (PFS) and overall survival (OS) when added to 5-FU/LV.
The phase 3 trial (ClinicalTrials.gov Identifier: NCT05074589) included 298 patients with locally advanced or metastatic pancreatic cancer who had failed first-line treatment with gemcitabine. The patients were randomly assigned to receive HR070803 plus 5-FU/LV (n=149) or placebo plus 5-FU/LV (n=149).
At baseline, the median age was 60 (range, 32-78) years in the HR070803 arm and 59 (range, 40-76) years in the placebo arm. Most patients (85% and 84%, respectively) had CA-199 levels of at least 40 U/mL, and most (74% and 67%) had metastatic lesions in the liver. In both arms, 93% of patients had received gemcitabine as part of a combination regimen.
The study’s primary endpoint was OS, and the median follow-up was 12.8 months. The median OS was 7.39 months in the HR070803 arm and 4.99 months in the placebo arm (hazard ratio [HR], 0.63; 95% CI, 0.48-0.84; P =.0019).
The median PFS was 4.21 months in the HR070803 arm and 1.48 months in the placebo arm (HR, 0.36; 95% CI, 0.27-0.48; P <.0001).
Grade 3 or higher adverse events (AEs) occurred in 53.1% of patients in the HR070803 arm and 46.3% of those in the placebo arm. The most common grade 3 or higher AEs in the HR070803 arm were neutropenia (12.9%), vomiting (4.8%), diarrhea (4.1%), fatigue (4.1%), and ALT elevation (4.1%).
Disclosures: This study was supported by Jiangsu Hengrui Pharmaceuticals Co., Ltd. The study authors declared no conflicts of interest.
Wang L, Qin S, Zhou Y, et al. HR070803 plus 5-FU/LV versus placebo plus 5-FU/LV in second-line therapy for gemcitabine-refractory locally advanced or metastatic pancreatic cancer: A multicentered, randomized, double-blind, parallel-controlled phase III trial (HR-IRI-APC). Presented at ESMO 2022; September 9-13, 2022. Abstract LBA61.