Onivyde (nanoliposomal irinotecan) / Servier, Ipsen, PharmaEngine - LARVOL DELTA

Impact of prior treatments on the efficacy of nanoliposomal irinotecan with fluorouracil and folinic acid for unresectable or recurrent pancreatic cancer (NAPOLEON-2 study) (ESMO Asia 2025) - "Background: Nanoliposomal irinotecan with fluorouracil and folinic acid (NFF) is a standard regimen for patients with unresectable or recurrent pancreatic cancer (urPC) after gemcitabine-based therapy. Our data suggest that NFF can be effective and a possible regimen regardless of prior exposure to IRI or FU, as well as prior primary tumor resection in the real-world."

Clinical • Oncology • Pancreatic Cancer • Solid Tumor

Real-world outcomes of long-term survivors of metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with liposomal irinotecan for the Japanese cohort of NALLONG study (ESMO Asia 2025) - P3 | "Background: The phase 3 NAPOLI-1 trial (NCT01494506) demonstrated improved overall survival (OS) and progression-free survival (PFS) with the combination of liposomal irinotecan (nal-IRI) and 5-fluorouracil/leucovorin (5-FU/LV) in patients (pts) with mPDAC pre-treated with a gemcitabine-based regimen. In this cohort of real-world Japanese mPDAC pts, we observed a population with exceptional response to systemic therapy. Importantly, nal-IRI achieved very favorable outcomes, and efficacy was observed independently of the line of treatment."

Clinical • Metastases • Real-world • Real-world evidence • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Predictors of prolonged progression-free survival in patients with unresectable or recurrent pancreatic cancer treated with nanoliposomal irinotecan with fluorouracil and folinic acid (NAPOLEON-2 study) (ESMO Asia 2025) - "Duration of previous chemotherapy and CAR can be useful in predicting PFS. Our nomogram may facilitate development of individualized treatment approaches and enhance decision-making in the management of urPC."

Clinical • Oncology • Pancreatic Cancer • Solid Tumor • CRP

Alternating neoadjuvant gemcitabine-nab-paclitaxel (GnP) and nal-irinotecan, 5-fluorouracil and folinic acid (nal-IRI) regimens in resectable (R) and borderline resectable (BR) pancreatic cancer (PC): A pilot study. (ASCO-GI 2026) - P1 | "Funded by Ipsen Clinical Trial Registration Number: NCT03703063 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

A phase II study of nanoliposomal irinotecan with TAS102 and bevacizumab for patients with refractory metastatic colorectal cancer (mCRC). (ASCO-GI 2026) - P2 | "Funded by Ipsen Clinical Trial Registration Number: NCT05854498 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Phase II study of NALIRIFOX (nanoliposomal irinotecan + oxaliplatin with fluorouracil and folinic acid) in advanced unresectable small bowel tumors. (ASCO-GI 2026) - P2 | "Funded by Ipsen Clinical Trial Registration Number: NCT06835387 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Metastases • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Small Intestinal Carcinoma

Liposomal irinotecan in patients with HER2-negative breast cancer and brain metastases: The PHENOMENAL phase 2 study. (PubMed, Eur J Cancer) - P2 | "nal-IRI demonstrated IC activity in HER2[-] BC with BMs. While overall efficacy was limited and long-term outcomes remain poor, these results highlight the unmet need in this challenging population and support the importance of developing more treatment strategies."

Journal • P2 data • Brain Cancer • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Optimized dose schedule of rucaparib and liposomal irinotecan/5-fluorouracil in metastatic gastrointestinal cancers: A phase 1 study. (PubMed, Cancer) - "This optimized dosing schedule successfully established the MTD for RUB with nal-IRI and 5-FU, overcoming prior challenges with PARP inhibitor and irinotecan combinations. The promising ORR and DCR support further evaluation of this regimen in advanced GI malignancies."

Journal • P1 data • Gastrointestinal Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • ATM • BRCA • HRD

Changing treatment outcomes in metastatic and recurrent pancreatic cancer: a real-world comparison before and after the availability of nanoliposomal irinotecan. (PubMed, Jpn J Clin Oncol) - "The introduction of nal-IRI plus 5-FU/LV was associated with improved second-line treatment outcomes, providing a new combination regimen with acceptable toxicity in metastatic or recurrent pancreatic cancer."

Journal • Real-world evidence • Oncology • Pancreatic Cancer • Solid Tumor

ONITT: Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: St. Jude Children's Research Hospital | Active, not recruiting ➔ Recruiting | N=46 ➔ 90

Enrollment change • Enrollment open • Embryonal Tumor • Ewing Sarcoma • Germ Cell Tumors • Hepatoblastoma • Nephrology • Neuroblastoma • Oncology • Osteosarcoma • Rhabdoid Tumor • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Wilms Tumor • EWSR1 • FLI1

Distinct morphological and internal state of irinotecan in liposomal structures: implications on irinotecan liposomal drug delivery. (PubMed, J Liposome Res) - "Further, these liposomes have a spherical morphology as opposed to the oblong or prolate morphology seen in irinotecan liposomes prepared with semi-crystalline TEA-8-SOS (similar to Onivyde®). SAXS power-law analysis also confirms low fractal dimension internal structures in liposomes prepared with liquid TEA-8-SOS compared to TRC's semi-crystalline, powder TEA-8-SOS."

Journal

Real-world efficacy of nanoliposomal irinotecan in patients with advanced pancreatic cancer. (PubMed, BMC Cancer) - No abstract available

Journal • Real-world evidence • Oncology • Pancreatic Cancer • Solid Tumor

Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma (clinicaltrials.gov) - P2 | N=52 | Recruiting | Sponsor: Medical University of South Carolina | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2027 ➔ Nov 2029 | Trial primary completion date: Mar 2026 ➔ May 2028

Enrollment open • Trial completion date • Trial primary completion date • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer

Impact of prior chemotherapy on nanoliposomal irinotecan with fluorouracil and folinic acid for unresectable pancreatic cancer: a retrospective analysis of data from the multicenter NAPOLEON-2 study. (PubMed, Ther Adv Med Oncol) - "We also investigated whether the treatment duration of gemcitabine plus nab-paclitaxel (GnP) influenced the efficacy of NFF among patients treated with NFF as a second-line therapy after GnP. The median OS in the group with previous GnP for ⩾7.8 months was 9.5 months, while it was 4.8 months in the group with GnP for <7.8 months (HR 0.50; p < 0.01). NFF may be effective and tolerable, even in patients previously treated with irinotecan-, fluorouracil-, or platinum-based chemotherapy, in the real world."

Journal • Retrospective data • Oncology • Pancreatic Cancer • Solid Tumor

Recent advancements in systemic therapy for biliary tract cancers: a literature review. (PubMed, J Gastrointest Oncol) - "BTCs have been traditionally managed with gemcitabine and cisplatin (GC), but this standard of care has shown limited efficacy due to early recurrence, high resistance rates, and molecular heterogeneity...Additionally, novel regimens including nanoliposomal irinotecan and dual ICI combinations represent viable second-line options...Personalized treatment guided by molecular characteristics is now central to improving outcomes. Future efforts must prioritize the identification of biomarkers, clarification of resistance mechanisms, and optimization of multimodal treatment strategies to maximize patient benefit."

IO biomarker • Journal • Review • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor • BRAF • FGFR2 • HER-2 • IDH1 • IDH2

Second-line 5-FU plus nanoliposomal irinotecan versus FOLFOX/XELOX in metastatic pancreatic cancer after gemcitabine-nab-paclitaxel failure: a propensity score-matched analysis. (PubMed, ESMO Open) - "5-FU + Nal-IRI showed a modest yet statistically significant survival advantage compared with FOLFOX/XELOX in patients with metastatic PDAC previously treated with GemNab, despite being associated with a higher incidence of adverse events. None the less, the selection of second-line therapy should be guided by a balanced evaluation of both efficacy and toxicity profiles."

Journal • Hematological Disorders • Oncology • Pain • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Thrombocytopenia

TRYBECA-1: A Randomized Phase III Study of Eryaspase Combined With Chemotherapy Versus Chemotherapy as Second-Line Treatment in Patients With Advanced Pancreatic Adenocarcinoma. (PubMed, J Clin Oncol) - P3 | "The addition of eryaspase to chemotherapy did not improve OS, PFS, or ORR. AEs were generally consistent with previous reports of chemotherapy. These results do not support additional development of eryaspase in PDAC."

Journal • P3 data • Hematological Disorders • Neutropenia • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Older Versus Younger Patients With Unresectable Pancreatic Cancer: The Multicenter NAPOLEON-2 Study. (PubMed, Asia Pac J Clin Oncol) - "Older patients with pancreatic cancer may benefit from NFF to the same extent as younger patients without severe adverse events. GNRI needs further study as a predictor of NFF efficacy in older patients."

Journal • Oncology • Pancreatic Cancer • Solid Tumor

A Randomized, Open-Label, Multicenter Phase II Clinical Study of Long-Course Chemoradiotherapy Followed by NALIRIFOX as Total Neoadjuvant Therapy for Locally Advanced Low-Lying pMMR/MSS Rectal Cancer (ChiCTR) - P2 | N=70 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New P2 trial • pMMR • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

Efficacy and Safety of AG Sequential NALIRIFOX in the Treatment of Unresectable Locally Advanced or Metastatic Pancreatic Cancer (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: Subei People's Hospital; Subei People's Hospital

New P4 trial • Oncology • Pancreatic Cancer • Solid Tumor

An Open-label, Single-center, Phase Ib Study of the Safety and Efficacy of Autologous NK Cell Therapy in Combination with Cetuximab Beta and NALIRIFOX as First-line Treatment in Patients with Locally Advanced Unresectable/Metastatic Pancreatic Cancer (ChiCTR) - P1 | N=30 | Not yet recruiting | Sponsor: The Affiliated Hospital of Qingdao University; The Affiliated Hospital of Qingdao University

New P1 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer: a Multicentre, Open-label, Randomised Trial (ChiCTR) - P4 | N=144 | Not yet recruiting | Sponsor: Zhongshan Hospital, Fudan University; Zhongshan Hospital, Fudan University

New P4 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor

Nanoliposomal irinotecan in combination with oxalipalatin and bevacizumab versus nanoliposomal irinotecan with 5-fluorouracil/leucovorin in metastatic pancreatic cancer after previous treatment-naive therapy: A multicenter, randomised, open-label, phase I/II trial (ESMO 2025) - P1/2 | "Methods The study enrolled patients with metastatic PDAC who had progressed after nab-paclitaxel and gemcitabine, aged 18–75 years...The MTD was determined to be nal-IRI 50 mg/m 2 , oxaliplatin 60 mg/m 2 , and bevacizumab 5 mg/kg, administered every 2 weeks...Legal entity responsible for the study The authors. Funding CSPC Pharmaceutical Group Co., Ltd and Qilu Pharmaceutical Group Co., Ltd."

Clinical • Combination therapy • Metastases • P1/2 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Impact of biliary drainage for unresectable pancreatic cancer treated with nanoliposomal irinotecan with fluorouracil and folinic acid: retrospective results from the NAPOLEON-2 study. (PubMed, BMC Cancer) - "BD had minimal impact on the efficacy of NFF in daily practice. Patients with total bilirubin ≥ 1.0 mg/dL had shorter OS than those with total bilirubin < 1.0 mg/dL."

Journal • Retrospective data • Hematological Disorders • Infectious Disease • Oncology • Pancreatic Cancer • Solid Tumor

Effect of dose adjustments on overall survival (OS) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with NALIRIFOX: a post hoc analysis of NAPOLI 3 (JADPRO 2025) - P3 | "BACKGROUND NALIRIFOX (liposomal irinotecan in combination with 5-fluorouracil/leucovorin plus oxaliplatin) is an FDA-approved, SMA-approved regimen based on the Phase 3 NAPOLI 3 trial for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). Approval was based on the results of NAPOLI 3 (NCT04083235), in 770 previously untreated patients with mPDAC, which demonstrated that NALIRIFOX significantly improved median overall survival (OS) (11.1 months) compared with gemcitabine plus nab-paclitaxel (8.6 months) with a clinically meaningful and statistically significant reduction in risk of death (HR, 0.83; 95% CI, 0.70–0.99; P=.036)...Longer OS may be related to longer time on therapy and an increased likelihood of dose adjustment. These data suggest a path forward to further optimize the OS of patients with mPDAC receiving NALIRIFOX."

Clinical • Metastases • Retrospective data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma