On December 9, 2020 Isofol Medical AB (publ) ("Isofol"), (Nasdaq First North Premier Growth Market: ISOFOL) reported that 440 patients has been successfully recruited in the global Phase III AGENT study for the treatment for advanced colorectal cancer (Press release, Isofol Medical, DEC 9, 2020, View Source [SID1234572507]).
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Isofol’s drug candidate, arfolitixorin, is evaluated for treatment of patients with first-line metastatic colorectal cancer (mCRC). The AGENT study is currently being conducted in the U.S., Canada, Europe, Australia and Japan at more than 90 clinics. The primary endpoint of the AGENT study is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR).
"It’s very satisfying to announce that we have recruited the required 440 patients into the AGENT study, an important milestone and an exceptional performance by the team and participating centers in these challenging times. We are now looking forward to the recommendation from iDSMB if the recruitment ends after 440 patients or is increased to 660 patients to strengthen the statistical power for Progression-Free Survival," said Ulf Jungnelius, M.D, CEO of Isofol.
The interim analysis is based on 330 patients and was initiated when the 330th patient had been treated for 16 weeks and had two tumor evaluations. Data is now being reviewed and quality controlled, once that has been done the iDSMB will evaluate safety and efficacy (ORR and trend in PFS). The company expect to receive this recommendation from iDSMB beginning of 2021.