The FDA has granted fast track designation to arfolitixorin (6R-MTHF) for patients with metastatic colorectal cancer (CRC), according to a press release from developer Isofol Medical AB. Arfolitixorin is a stabilized and biologically active pure form of the folate that helps to increase 5-fluorouracil (5-FU)–cytotoxicity. This decision underscores the potential for arfolitixorin to fulfill currently unmet clinical needs and to offer more effective treatment options for patients with metastatic disease.
Arfolitixorin is currently under evaluation as part of the phase 3 AGENT study (NCT03750786), which seeks to assess progression-free survival events among patients treated with the drug. The clinical trial enrolled 490 patients with advanced CRC who were randomized to receive either arfolitixorin or a leucovorin plus 5-FU combination. The primary end point of the study is to assess the overall response rate, with key secondary end points including progression-free survival and duration of response.
In group A, patients will receive arfolitixorin and 5-FU, oxaliplatin, and bevacizumab and those in group B, patients will receive leucovorin, 5-FU, oxaliplatin, and bevacizumab (Avastin). Eligibility for the trial required patients to have colorectal adenocarcinoma verified via a biopsy, non-resectable metastatic disease, and plans to receive a first-line therapy consisting of 5-FU, oxaliplatin, and bevacizumab. Patients also needed to have evaluable disease with at least 1 measurable lesion.
Isofol aims to conclude the phase 3 study by the end of 2022 and apply for approval for arfolitixorin with the FDA and European Medicines Agency.