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Novel Liposome Formulation of Irinotecan Plus Chemotherapy Improved Survival Outcomes for Locally Advanced and Metastatic Pancreatic Cancer
HR070803, a liposome formulation of irinotecan, improved survival outcomes for patients with locally advanced or metastatic pancreatic cancer who have previously failed on gemcitabine-based therapy.
This abstract was presented on Saturday, September 10, 2022, at the European Society for Medical Oncology Congress in Paris, France, by first author, Liwei Wang, MD, department of oncology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
This double-blind, multi-center, phase 3 trial enrolled 298 patients with locally advanced or metastatic pancreatic cancer from January 2018 to May 2021. Patients were randomized on a 1:1 basis to receive either 56.5 mg/m2 HR070803 plus 2000/200mg/m2 5-fluorouracil-leucovorin chemotherapy regimen (5-FU/LV), or placebo plus 5-FU/LV. The primary end point was overall survival (OS), with progression-free survival (PFS), objective response rate (ORR), and safety as secondary end points.
At the data cutoff date of November 18, 2021, the median follow-up duration was 12.81 months. The median OS was 7.39 months (95% confidence interval [CI], 6.05 to 8.41) in the treatment arm and 4.99 months (95% CI, 4.27 to 6.01) in the placebo arm, meeting the primary end point (hazard ratio [HR]: 0.63; 96.4%CI, 0.48 to 0.84; P = .0019). Median PFS was 4.21 months (95% CI, 2.92 to 5.59) in the treatment arm compared to 1.48 months (95%CI, 1.14 to 1.58) in the placebo arm (HR: 0.36; 95%CI, 0.27 to 0.48; P < .0001). The ORR was 12.75% (95%CI, 7.86 to 19.20) in the treatment arm and 0.67% (95%CI, 0.02 to 3.68) in the placebo arm (P < .0001).
The most common grade ≥3 adverse events in the treatment arm were γ-GGT elevations and neutropenia. In the treatment arm, incidence of grade ≥3 diarrhea was 4.08% and neutropenia was 12.93%
The study authors concluded “these data suggest HR070803 plus 5-FU/LV is a new treatment selection for the population.”
Source:
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 European Society for Medical Oncology Congress; September 9-13, 2022. Paris, France.
