XBiotech discontinues Xilonix CRC trial

XBiotech Inc. (NASDAQ:XBIT) said it is discontinuing the Phase III XCITE trial of Xilonix (CV-18C3, T2-18C3, RA-18C3, MABp1, CA-18C3) to treat colorectal cancer in about 643 patients. An IDMC recommended the study's termination based on an interim efficacy analysis. The company said it would analyze the data “in the coming weeks” to identify patient populations that may have benefited from treatment.

The double-blind, placebo-controlled, U.S. trial evaluated IV Xilonix every 2 weeks plus best supportive care (BSC) in advanced colorectal cancer patients who failed regimens that included fluoropyrimidines, oxaliplatin, irinotecan and Erbitux cetuximab from Eli Lilly and Co. (NYSE:LLY), or Vectibix panitumumab from Amgen Inc. (NASDAQ:AMGN) in K-Ras (KRAS) mutation-positive patients. The trial’s primary endpoint was overall survival (OS). Secondary endpoints included change in lean body mass, quality of life (QOL), progression-free survival (PFS) and objective response rate (ORR)...