Onivyde (nanoliposomal irinotecan)

P2, N=120, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University

P=N/A, N=163, Active, not recruiting, Servier Affaires Médicales | Recruiting --> Active, not recruiting | Trial completion date: Jan 2024 --> Sep 2024

The addition of durvalumab to a gemcitabine plus cisplatin regimen has significantly improved overall survival in the phase 3 TOPAZ-1 trial and is currently recommended as a standard first-line treatment. The phase 3 ABC-06 and phase 2b NIFTY trials have shown the benefit of second-line fluoropyrimidine plus oxaliplatin, and fluoropyrimidine plus nanoliposomal irinotecan, respectively...However, most patients eventually show resistance to the treatment, and tumor progression occurs within a year. Indeed, there should be further efforts to improve the outcomes of patients with advanced IHCCA.

P2, N=200, Recruiting, Seoul National University Hospital | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P2, N=55, Active, not recruiting, MedSIR | Trial completion date: Mar 2024 --> Jun 2025

P1/2, N=79, Active, not recruiting, Famewave Ltd. | Trial completion date: Mar 2024 --> Jan 2025 | Trial primary completion date: Feb 2024 --> Dec 2024

P2, N=55, Active, not recruiting, MedSIR | Recruiting --> Active, not recruiting

P2, N=40, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

P2, N=63, Recruiting, MedSIR | Trial completion date: Dec 2024 --> Mar 2024

P2, N=28, Active, not recruiting, Nelson Yee | Recruiting --> Active, not recruiting | Trial completion date: Nov 2023 --> Aug 2024

P1, N=122, Recruiting, Ipsen | Trial completion date: Mar 2024 --> Jul 2024

P3, N=770, Active, not recruiting, Ipsen | Trial completion date: Dec 2023 --> Dec 2024

P1/2, N=96, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital

P1/2, N=79, Active, not recruiting, Famewave Ltd. | Recruiting --> Active, not recruiting

P2, N=41, Not yet recruiting, Institut de Recherches Internationales Servier

P1/2, N=100, Recruiting, St. Jude Children's Research Hospital | Not yet recruiting --> Recruiting | Initiation date: Nov 2023 --> Feb 2024

P2, N=123, Recruiting, AstraZeneca

P2, N=134, Not yet recruiting, Changhai Hospital

P1/2, N=40, Active, not recruiting, Asan Medical Center | Trial completion date: Dec 2023 --> Dec 2024

P1/2, N=64, Recruiting, Emory University | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2023 --> Nov 2024

P=N/A, N=58, Completed, University Hospital, Bordeaux | Not yet recruiting --> Completed

P2, N=63, Not yet recruiting, Harbin Medical University

P2, N=45, Active, not recruiting, University of Florida

P1/2, N=79, Recruiting, Famewave Ltd.

P2, N=44, Recruiting, Georgetown University | Trial primary completion date: Nov 2023 --> May 2024

P2, N=176, Active, not recruiting, ECOG-ACRIN Cancer Research Group | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2025

P2, N=106, Active, not recruiting, Federation Francophone de Cancerologie Digestive | Recruiting --> Active, not recruiting

CA19-9 decrease by week 16 has the potential to be an early prognostic factor for OS, PFS and ORR. The results should be interpreted with caution as a considerable percentage of patients were excluded due to non-evaluable CA19-9 that exceeded the lab detection limit of 8000 kU/L. Clinical trial information: NCT04083235.

P=N/A, N=150, Recruiting, Servier Affaires Médicales

P1/2, N=18, Active, not recruiting, Academic and Community Cancer Research United | Phase classification: P2 --> P1/2 | Trial primary completion date: Jan 2020 --> Feb 2024

P2, N=43, Active, not recruiting, Cardiff Oncology | Recruiting --> Active, not recruiting

P2, N=200, Recruiting, Seoul National University Hospital | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Dec 2023

P1, N=44, Completed, PharmaEngine | Active, not recruiting --> Completed

P1/2, N=69, Active, not recruiting, XBiotech, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> May 2024 | Trial primary completion date: Jul 2023 --> Feb 2024

P1, N=122, Recruiting, Ipsen | Trial completion date: Nov 2023 --> Feb 2024 | Trial primary completion date: Nov 2023 --> Feb 2024

Background Nano-liposomal irinotecan with fluorouracil and folinic acid (NFF) is a standard treatment for advanced pancreatic cancer after gemcitabine-based chemotherapy. Conclusions These results reproduced the retrospective portion in the safety of NFF, validating this interim analysis. NFF was safely administered in practical clinical settings, so we determined that enrollment should be continued.

Background Nanoliposomal irinotecan with fluorouracil and folinic acid (Nal-IRI/FU/LV; NFF) is a standard treatment after gemcitabine-based chemotherapy for unresectable pancreatic cancer (uPC) patients (pts). Conclusions NFF more frequently caused severe non-hematological AEs and biliary tract infections in the BD group. Therefore, more attention should be paid to pts with prior BD for safety.

Nanoliposomal-irinotecan and fluorouracil with leucovorin (NFF) has emerged as the standard treatment following gemcitabine-based regimens. Cox regression analysis indicated that neutropenia was significantly associated with OS at Cutoff A and B (adjusted p<0.05). Conclusions NFF-induced neutropenia exhibits significant potential as both a predictive factor for treatment response and a prognostic factor for OS in patients with pancreatic cancer.

Cohort 1 included 292 pts treated with gemcitabine/nab-PTX (GnP, 184 pts) and FOLFIRINOX (FFX, 108 pts) as first-line chemotherapy, and Cohort 2 included 88 pts treated with nanoliposomal irinotecan, fluorouracil and folinic acid as second-line chemotherapy. The mOS was significantly longer in Group C (10.9 months) than in Group A (4.6 months; HR 0.33, 95% CI 0.17–0.65, p<0.01), but mOS in Group B (6.8 months) did not differ significantly from Group A (p=0.10). Conclusions This is the first report that DpR and ETS might be predictors of OS in pts with PC on standard chemotherapy.

For the first-line treatment of locally advanced or metastatic cholangiocarcinoma, cisplatin/gemcitabine has been the standard of care for more than 10 years. Its combination with the immune checkpoint inhibitor durvalumab resulted in an efficiency improvement in the phase III setting...The evidence base for nanoliposomal irinotecan (Nal-IRI) plus 5-fluorouracil (5-FU) and leucovorin (LV) is contradictory...These targeted agents are generally preferable to second-line chemotherapy. Broad molecular testing should be performed, preferably from tumor tissue, at the initiation of first-line therapy to timely identify potential molecular targets.

Evidence from recent clinical studies has shown that liposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU) and leucovorin (LV) resulted in survival benefits in patients with advanced pancreatic adenocarcinoma (APAC) after progression on gemcitabine-based treatment. Nal-IRI plus 5FU/LV had modest survival benefits and an acceptable safety profile in patients with prior conventional IRI. A longer interval between conventional IRI and nal-IRI was associated with increased survival outcomes.

Currently, nanoliposomal irinotecan (nal-IRI) + 5-fluorouracil/folinic acid (5-FU/LV) is the only approved second-line treatment for patients suffering from metastatic pancreatic ductal adenocarcinoma (mPDAC). Nal-IRI + 5-FU/LV is a valuable, effective, and safe sequential treatment option following gemcitabine-based therapy in patients with mPDAC. Retrospective study on the efficacy and tolerability of liposomal irinotecan (NALIRI); ClinicalTrials.gov Identifier: NCT0509506 (https://clinicaltrials.gov/ct2/show/NCT05095064?term=naliri&draw=2&rank=2).