NEW YORK – Isofol Medical on Wednesday said it will not continue a Phase III study of arfolitixorin in advanced colorectal cancer patients following a negative data readout, but it will continue to analyze the commercial value of the drug in biomarker-defined subgroups.
The trial, dubbed AGENT, randomized nearly 500 advanced colorectal cancer patients to the folate-based investigational drug arfolitixorin plus chemotherapy and Genentech's anti-angiogenic drug Avastin (bevacizumab) or the folate acid leucovorin plus chemotherapy and Avastin. According to Gothenburg, Sweden-based Isofol, the drug failed to show any concrete value in the study.
The most recent data readout showed no difference in overall response rate, the primary endpoint in the trial, between the two study arms. The median progression-free survival was only improved by one month with arfolitixorin, and the overall survival analysis showed a trend toward worse outcomes on the experimental drug versus the control arm.
Although the negative outcomes justify terminating the trial this fall, Isofol continues to analyze data related to subgroups and gene expression. So far, there haven't been any valuable results in these subgroup analyses, but the firm is still collecting data.
"This is a huge disappointment given the large medical need for new treatments of advanced colorectal cancer," Isofol CEO Ulf Jungnelius said in a statement. "Even if the opportunities of finding results that indicate commercial value are limited, we will continue to analyze the AGENT study's data as it becomes available."
The firm's board of directors is looking into next steps for the company, including potential clinical collaborations or mergers. Due to cost concerns related to shutting down the AGENT study, Isofol is not pursuing additional in-house clinical trials.