Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial).


Journal Article

Talactoferrin alfa is an oral dendritic cell (DC)-mediated immunotherapy (DCMI). We tested whether talactoferrin was superior to placebo in advanced non-small-cell lung cancer (NSCLC).An FORTIS-M trial was an international, multicenter, randomized, double-blind comparison of talactoferrin (1.5 g p.o. BID) versus placebo BID, in patients with stage IIIB/IV NSCLC whose disease had failed two or more prior regimens. Treatment was administered for a maximum of five 14-week cycles. The primary efficacy end point was overall survival (OS); secondary end points included 6- and 12-month survival, progression-free survival (PFS), and disease control rate (DCR).Seven hundred and forty-two patients were randomly assigned (2:1) to talactoferrin (497) or placebo (245). The median OS in the intent-to-treat (ITT) population was 7.66 months in the placebo arm and 7.49 months in the talactoferrin arm [hazard ratio (HR), 1.04; 95% CI, 0.873-1.24; P = 0.6602]. The 6-month survival rates were 59.9% (95% CI, 53.4% to 65.8%) and 55.7% (95% CI, 51.1% to 59.9%), respectively. The 12-month survival rates were 32.2% (95% CI, 26.3% to 38.2%) and 30.9% (95% CI, 26.8% to 35%), respectively. The median PFS rates were 1.64 months and 1.68 months, respectively (HR, 0.99; 95% CI, 0.835-1.16; P = 0.8073). The DCRs were 38.4 and 37.6%, respectively [stratified odds ratio (OR), 0.96; 95% CI, 0.698-1.33; P = 0.8336]. The safety profiles were comparable between arms.There was no improvement in efficacy with talactoferrin alfa in patients with advanced NSCLC whose disease had failed two or more previous regimens.

Full Text

Duke Authors

Cited Authors

  • Ramalingam, S; Crawford, J; Chang, A; Manegold, C; Perez-Soler, R; Douillard, J-Y; Thatcher, N; Barlesi, F; Owonikoko, T; Wang, Y; Pultar, P; Zhu, J; Malik, R; Giaccone, G; FORTIS-M Study Investigators,

Published Date

  • November 2013

Published In

Volume / Issue

  • 24 / 11

Start / End Page

  • 2875 - 2880

PubMed ID

  • 24050956

Pubmed Central ID

  • 24050956

Electronic International Standard Serial Number (EISSN)

  • 1569-8041

International Standard Serial Number (ISSN)

  • 0923-7534

Digital Object Identifier (DOI)

  • 10.1093/annonc/mdt371


  • eng