Isofol Medical has announced that neither the primary endpoint of Overall Response Rate (ORR) nor the key secondary endpoint in Progression Free Survival (PFS) achieved statistical significance in the multi-center, international Phase III AGENT Study of arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab in metastatic colorectal cancer (mCRC).
The AGENT Study is the first to evaluate a meaningful alternative to the standard of care for all patients with mCRC since 2004, describes the company. In the AGENT study, patients with non-resectable mCRC treated with arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab did not achieve a statistically significant overall response rate of ≥ 10% as compared to patients treated with the standard of care (leucovorin + 5-FU, oxaliplatin and bevacizumab).
“We are all surprised and disappointed”
“We are all surprised and disappointed in the results as we invested so much hope into improving the treatment for patients suffering mCRC. I would like to thank all the patients, clinical investigation sites and other participants that contributed to the study,” said Ulf Jungnelius, CEO of Isofol. “We will complete the data analysis before confirming next steps and look forward to working with regulatory agencies to consider alternative paths forward. Decisions related to Isofol’s clinical program will be on hold until we’ve consulted with relevant regulatory bodies which is tentatively planned during the first half of 2023.”
The AGENT Study will be completed in accordance with applicable regulations and the full data set will be published in order to enable the scientific community to fully take advantage of learnings. Sub-group analyses, gene expression and safety data is expected to be available in the final study report in Q4 2022. Pending results of further analyses, patients remaining on treatment in the experimental arm of the study will be offered to move to the standard of care treatment arm.
Photo of Ulf Jungnelius: isofolmedical.com