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

S. Ramalingam, J. Crawford, A. Chang, C. Manegold, R. Perez-Soler, J. Y. Douillard, N. Thatcher, F. Barlesi, T. Owonikoko, Y. Wang, P. Pultar, J. Zhu, R. Malik, R. Malik Giaccone, S. Della-Fiorentina, S. Begbie, R. Jennens, J. Dass, K. Pittman, N. IvanovaT. Koynova, P. Petrov, A. Tomova, V. Tzekova, F. Couture, V. Hirsh, R. Burkes, R. Sangha, M. Ambrus, T. Janaskova, J. Musil, J. Novotny, P. Zatloukal, J. Jakesova, K. Klenha, J. Roubec, J. Vanasek, J. Fayette, F. Barlesi, J. Bennouna-Louridi, C. Chouaid, J. Mazières, H. Vallerand, G. Robinet, P. J. Souquet, D. Spaeth, R. Schott, H. Lena, Y. Martinet, C. E. Kouri, N. Baize, A. Scherpereel, O. Molinier, F. Fuchs, K. M. Josten, C. Manegold, N. Marschner, F. Schneller, T. Overbeck, M. Thomas, J. von Pawel, M. Reck Schuette, V. Hagen, C. P. Schneider, V. Georgoulias, I. Varthalitis, K. Zarogoulidis, K. Syrigos, C. Papandreou, C. Bocskei, E. Csanky, E. Juhasz, G. Losonczy, Z. Mark, I. Molnar, Z. Papai-Szekely, S. Tehenes, I. Vinkler, S. Almel, A. Bakshi, S. Bondarde, A. Maru, A. Pathak, R. M. Pedapenki, K. Prasad, S. V.S.S. Prasad, N. Kilara, D. Gorijavolu, C. D. Deshmukh, S. John, L. M. Sharma, D. Amoroso, E. Bajetta, P. Bidoli, A. Bonetti, F. De Marinis, M. Maio, R. Passalacqua, S. Cascinu, A. Bearz, M. Bitina, A. Brize, G. Purkalne, M. Skrodele, A. A. Baba, K. Ratnavelu, M. H. Saw, M. C. Samson-Fernando, G. E. Ladrera, J. Jassem, P. Koralewski, L. Sikorska, P. Serwatowski, M. Krzakowski, C. Cebotaru, D. Filip, D. E. Ganea-Motan, C. H. Ianuli, I. G. Manolescu, A. Udrea, O. Burdaeva, M. Byakhov, A. Filippov, S. Lazarev, I. Mosin, S. Orlov, D. Udovitsa, A. Khorinko, S. Protsenko, A. Chang, H. L. Lim, Y. O. Tan, E. H. Tan, R. Bastus Piulats, J. Garcia-Foncillas, J. Valdivia, J. de Castro, M. Domine Gomez, S. W. Kim, J. S. Lee, H. K. Kim, J. S. Lee, S. W. Shin, D. W. Kim, Y. C. Kim, K. C. Park, C. S. Chang, G. C. Chang, Y. G. Goan, W. C. Su, C. M. Tsai, H. P. Kuo, M. Benekli, G. Demir, E. Gokmen, A. Sevinc, J. Crawford, G. Giaccone, M. Haigentz, T. Owonikoko, M. Agarwal, S. Pandit, R. Araujo, N. Vrindavanam, P. Bonomi, A. Berg, J. Wade, R. Bloom, B. Amin, R. Camidge, D. Hill, M. Rarick, P. Flynn, L. Klein, K. Lo Russo, M. Neubauer, P. Richards, R. Ruxer, M. Savin, D. Weckstein, R. Rosenberg, T. Whittaker, D. Richards Berry, C. Ottensmeier, A. Dangoor, N. Steele, Y. Summers, E. Rankin, K. Rowley, S. Giridharan, H. Kristeleit, C. Humber, P. Taylor

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Abstract

Background: 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). Patients and methods: 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). Results: 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. Conclusions: There was no improvement in efficacy with talactoferrin alfa in patients with advanced NSCLC whose disease had failed two or more previous regimens.

Original languageEnglish
Article numbermdt371
Pages (from-to)2875-2880
Number of pages6
JournalAnnals of Oncology
Volume24
Issue number11
DOIs
Publication statusPublished - Nov 1 2013

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Keywords

  • Immunotherapy
  • Non-small-cell lung cancer
  • Phase III study
  • Talactoferrin

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

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., Malik Giaccone, R., Della-Fiorentina, S., Begbie, S., Jennens, R., Dass, J., Pittman, K., ... Taylor, P. (2013). Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial). Annals of Oncology, 24(11), 2875-2880. [mdt371]. https://doi.org/10.1093/annonc/mdt371