Date: 2011-10-11
Type of information:
phase: 2
Announcement: results (publication in Journal of Clinical Oncology of the article, “A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oral Talactoferrin in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer that Progressed Following Chemotherapy,” by P. Parikh et al)
Company: Agennix (Germany)
Product: talactoferrin
Action mechanism: Talactoferrin is an oral immunotherapy that is being studied for the treatment of cancer and severe sepsis.
Disease: non-small cell lung cancer
Therapeutic area: Cancer Oncology
Country:
Trial details: The published randomized Phase II trial enrolled 100 patients with stage IIIB/IV non-small cell lung cancer whose disease had progressed following one or more lines of anti-cancer therapy and evaluated the use of talactoferrin plus best supportive care compared to placebo plus best supportive care.
Latest
news: Agennix announced that data from a Phase II randomized, double-blind, placebo-controlled clinical trial evaluating the oral immunotherapy, talactoferrin, in patients with previously treated non-small cell lung cancer (NSCLC) have been published in the peer-reviewed medical journal, Journal of Clinical Oncology. As previously reported, this study, conducted in patients with NSCLC for whom one or more prior lines of anti-cancer therapy had failed, achieved its primary endpoint of improvement in overall survival. Talactoferrin was shown to be very well tolerated in this study, with fewer adverse events compared to placebo. The most frequently reported severe (grade 3 or greater) adverse event was dyspnea (labored breathing), which occurred in 15% of patients in the talactoferrin arm and 26% in the control arm. There were no serious adverse events considered to be related to treatment with talactoferrin.
Talactoferrin also appeared to improve survival across a broad range of patient subsets, including those with squamous and non-squamous histologies, as well as other important prognostic factors.
The results of this study served as the basis for the ongoing talactoferrin Phase III FORTIS-M trial, which is being conducted in patients whose disease has progressed following two or more prior treatment regimens. The FORTIS-M study has completed enrollment and topline results are expected in the first half of 2012.
The published randomized Phase II trial enrolled 100 patients with stage IIIB/IV non-small cell lung cancer whose disease had progressed following one or more lines of anti-cancer therapy and evaluated the use of talactoferrin plus best supportive care compared to placebo plus best supportive care.
The results showed that talactoferrin improved median overall survival by 65% compared to placebo [6.1 months versus 3.7 months, hazard ratio = 0.68, 90% Confidence Interval: 0.47-0.98, p=0.04 (one-tailed log-rank test)], meeting the protocol-defined level of statistical significance. The six-month overall survival rate was 30% in the placebo arm and 52% in the talactoferrin arm. The one-year overall survival rate was 16% in the placebo arm compared to 29% in the talactoferrin arm. Supportive results were seen in the secondary endpoints of progression-free survival and disease control rate. The above analyses were conducted on an intent-to-treat basis.
