The new data comes from the two safety extension cohorts of 31 evaluable patients who have been followed and evaluated with CT-scans after 16 weeks or longer, to analyze the exploratory endpoint best ORR - defined as percentage of patients whose disease decreased more than 30% and/or disappears after treatment - which is the primary endpoint in the AGENT-study. Out of the 31 patients, 17 were treated with an ARFOX regimen*, which is the experimental regimen in the ongoing AGENT-study. A best ORR of 59% was observed in the ARFOX regimen group versus 50% in the ARFIRI regimen** group, despite a high frequency of right-sided tumor location and BRAF mutation, both being poor prognostic factors for response. In total, the data resulted in a best ORR of 55 %.
For more information about the 005-study, please visit: https://isofolmedical.com/005-study/
* arfolitixorin and 5-fluorouracil (5-FU) + oxaliplatin
** arfolitixorin and 5-fluorouracil (5-FU) + irinotecan
For further information, please contact
Jarl Ulf Jungnelius, M.D., Chief Executive Officer
E-mail: jungnelius@isofolmedical.com
Mobil: +46 (0) 709 16 89 55
Certified Adviser
E-mail: info@fnca.se
Phone: +46 (0)8 528 003 99
The information was submitted for publication, through the agency of the contact person set out above, at
About arfolitixorin
Arfolitixorin is Isofol's proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III clinical study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.
About the AGENT study
The global Phase III AGENT clinical study is a randomized, controlled, multi-center study assessing the efficacy and safety of arfolitixorin compared to leucovorin, both studied in combination with 5-FU, oxaliplatin, and bevacizumab, as first-line treatment for mCRC patients. The study is designed to show superiority for arfolitixorin over leucovorin. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumor cells. The study is ongoing at approximately 90 sites in the
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https://news.cision.com/isofol-medical-ab--publ-/r/55---overall-response-rate-on-the-safety-extension-cohorts-of-the-iso-cc-005-phase-i-iia-study,c3205100
https://mb.cision.com/Main/15598/3205100/1312674.pdf
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