A Study to Compare the Efficacy of Arfolitixorin Versus Leucovorin in Combination With 5 Fluorouracil, Oxaliplatin, and Bevacizumab in Patients With Advanced Colorectal Cancer

Summary

This is a multicenter, randomized, parallel-group, Phase III study in at least 440 patients with advanced colorectal cancer to compare the efficacy of treatment with arfolitixorin versus Leucovorin in combination with 5-fluorouracil, oxaliplatin, and bevacizumab according to modified FOLFOX-6 until PD according to RECIST 1.1 criteria.

Timeline

Start

2018-12-18

Primary completion

2022-11-18

Completion

2022-11-18

Outcome

Missed primary endpoint

paper the primary endpoint of superiority for ORR was not achieved (48.2% for arfolitixorin vs. 49.4% for leucovorin, Psuperiority = 0.57). PMID 38059497 ↗

release “Neither the primary endpoint of objective response rate (ORR) nor the key secondary endpoint of progression-free survival (PFS) were met.” isofolmedical.com ↗

Publications

• Tabernero J, Yoshino T, Stintzing S, de Gramont A, Gibbs P, Jonker DJ, Nygren P, Papadimitriou C, Prager GW, Tell R, Lenz HJ. A Randomized Phase III Study of Arfolitixorin versus Leucovorin with 5-Fluorouracil, Oxaliplatin, and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer: The AGENT Trial. Cancer Res Commun. 2024 Jan 4;4(1):28-37. doi: 10.1158/2767-9764.CRC-23-0361.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Arfolitixorin	Small molecule	60 mg/m2	Intravenous
Comparator	Leucovorin	Small molecule	400 mg/m2	Intravenous
Background	Bevacizumab	Monoclonal antibody	5 mg/kg	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous

Indications