Onivyde (nanoliposomal irinotecan)

FOLFIRINOX appears the most effective option for carefully selected, fit patients eligible for 2L chemotherapy after GnP failure. Interpretable artificial intelligence-derived treatment policies may provide superior net clinical benefit compared to uniform approaches and guide individualized therapy, warranting integration with upcoming targeted strategies such as RAS inhibitors.

P=N/A, N=49, Recruiting, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

P=N/A, N=90, Active, not recruiting, SONIRE Therapeutics Inc. | Recruiting --> Active, not recruiting | Trial completion date: Sep 2026 --> May 2027 | Trial primary completion date: Sep 2026 --> May 2027

Among patients with BRCA2 PVs treated with GnP, OS was numerically longer with second-line FFX than with nal-IRI/5-FU/leucovorin (HR 0.51; p = 0.119)...In BRCA2 PV tumors, greater tumor shrinkage with first-line FFX did not translate into longer OS, underscoring the importance of sequencing strategies that ensure timely exposure to platinum-based therapy. TMB-high tumors may benefit from timely access to immunotherapy.

P3, N=614, Recruiting, Astellas Pharma Global Development, Inc. | Not yet recruiting --> Recruiting

P2, N=45, Active, not recruiting, University of Florida | Trial completion date: Feb 2026 --> Dec 2026

P3, N=94, Recruiting, SWOG Cancer Research Network | Not yet recruiting --> Recruiting

P3, N=614, Not yet recruiting, Astellas Pharma Global Development, Inc.

P2, N=224, Recruiting, AstraZeneca | Trial completion date: Dec 2026 --> Sep 2027 | Trial primary completion date: Dec 2025 --> Aug 2026

P1/2, N=90, Recruiting, St. Jude Children's Research Hospital | Trial completion date: Dec 2025 --> Dec 2026

P2, N=56, Recruiting, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Not yet recruiting --> Recruiting

Liposomal irinotecan in combination with 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) is the only approved therapy for metastatic PAC following gemcitabine-based therapy, based on the survival benefit demonstrated in the phase III NAPOLI-1 trial. Factors such as patient age and number of previous lines of treatment that were not identified in the NAPOLI-1 nomogram may be associated with long-term survival with nal-IRI+5-FU/LV in the real-world. In conclusion, this review has shown that while prognostic factors are useful for patient stratification, their predictive value on the efficacy of nal-IRI+5-FU/LV is low, thus this treatment may also result in long-term survival in patients with apparently unfavorable characteristics.