BioCentury
ARTICLE | Clinical News

Talactoferrin: Phase III data

December 17, 2012 8:00 AM UTC

Data from 94 patients with NSCLC in the discontinued, double-blind, U.S. Phase III FORTIS-C trial showed that twice-daily 1.5 g oral talactoferrin in combination with carboplatin plus paclitaxel as first-line treatment led to an investigator-reported median PFS of 5.8 months vs. 5.6 months for placebo plus chemotherapy (p=0.89). Median OS was 11.4 months in the talactoferrin arm vs. 12.7 months in the placebo arm (p=0.36). In August, Agennix discontinued the FORTIS-C trial, which had planned to enroll 1,100 patients, after data from the Phase III FORTIS-M trial in 742 stage IIIb/IV NSCLC patients who have failed >=2 prior therapies showed that twice-daily 1.5 g oral talactoferrin plus best supportive care (BSC) missed the primary endpoint of median OS vs. placebo plus BSC (7.5 vs. 7.7 months, p=0.66) (see BioCentury, Aug. 13). ...