Date: 2012-08-06
Type of information:
phase: 3
Announcement: results
Company: Agennix (Germany)
Product: talactoferrin alfa (talactoferrin)
Action mechanism: Talactoferrin is an oral biologic therapy with immunomodulatory and antibacterial properties, which is being studied for the treatment of cancer and severe sepsis.
Disease: patients with non-small cell lung cancer (NSCLC) whose disease had progressed following two or more prior treatment regimens.
Therapeutic area: Cancer - Oncology
Country: North America, Europe, Asia/Pacific region.
Trial
details: The FORTIS-M trial is a randomized, double-blind, placebo-controlled Phase III trial evaluating talactoferrin plus best supportive care compared to placebo plus best supportive care in Stage IIIb/IV NSCLC patients whose disease has progressed following two or more prior treatment regimens. There were 742 patients enrolled in the trial from over 160 clinical sites in North America, Europe and the Asia/Pacific region.
Latest
news: Agennix has announced that the FORTIS-M Phase III trial with talactoferrin alfa (talactoferrin) did not meet
its primary endpoint of improving overall survival. The FORTIS-M trial evaluated talactoferrin plus best supportive care compared to placebo plus best supportive care in patients with non-small cell lung cancer (NSCLC) whose disease had progressed following two or more prior treatment regimens.
Median overall survival in the talactoferrin arm was 7.5 months compared to 7.7 months for placebo (hazard ratio 1.04, p-value 0.66).
The nature and incidence of adverse events in the talactoferrin arm were similar to that of placebo and consistent with previous clinical trials.
The company has announced that it will provide more details on its corporate plans in the near future.
