Data from a Phase II randomized, double-blind, placebo-controlled clinical trial which assessed talactoferrin (an oral immunotherapy) in individuals who had previously received treatment for non-small cell lung cancer (NSCLC) has been published and will appear in the November 1, 2011 print issue of the peer-reviewed medical journal, Journal of Clinical Oncology, Agennix AG . The report “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” is written by P. Parikh and colleagues.
The investigation, conducted on individuals for whom one or more previous types of anti-cancer treatments for NSCLC had failed, reached its initial endpoint of improvement in overall survival. In addition the drug seemed to improve survival rates across a wide range of patient subsets, including patients with non-squamous and squamous histologies, and other crucial prognostic factors. Results from this investigation formed the foundation for the talactoferrin Phase III FORTIS-M trial that is currently in process. The Phase III trial is being carried out in individuals whose NSCLC has progressed after two or more previous treatment methods. Enrollment for the FORTIS-M investigation has been completed, with results expected in the first half of 2012.
Rajesh Malik, M.D., Chief Medical Officer, explained:
“There is a major need for effective, easy-to-use, well tolerated treatments for patients with refractory non-small cell lung cancer. The promising results from this study show the potential of talactoferrin to improve survival where previous therapies have failed, including effects across a broad range of clinically important subsets.
Talactoferrin appears to provide anti-tumor activity without many of the common toxicities associated with other treatments for non-small cell lung cancer. In addition, talactoferrin is an oral liquid that offers convenience for both patients and physicians to use. We look forward to reporting topline results from our ongoing Phase III FORTIS-M registration trial in advanced non-small cell lung cancer in the first half of 2012.”
The Phase II study enrolled 100 individuals with stage IIIB/IV NSCLC whose cancer had advanced after one or more forms of anti-cancer treatments failed. The participants where then assigned to two groups, one group received talactoferrin in addition to best supportive care and the other group received placebo plus best supportive care.
After evaluation, the results revealed that talactoferrin improved median overall survival by 65% in comparison to those in the placebo group (6.1 months vs. 3.7 months, hazard ratio = 0.68, 90% Confidence Interval: 0.47-0.98, p=0.04 [one-tailed log-rank test]), reaching the protocol-defined level of statistical significance. For those in the talactoferrin group, the six-month overall survival was 52% compared to 30% in the placebo group. Patients in the placebo group had a one-year overall survival rate of 16% compared to 29% in the talactoferrin group. Encouraging results were observed in the secondary endpoints of disease control rate and progression-free survival. The above examination was carried out with the intention to treat.
In the investigation, it was shown that talactoferrin was very well tolerated, with less side effects compared to placebo. Dyspnea (labored breathing) was the most prevalent reported (grade 3 or higher) side effect, which occurred in 26% of patients in the placebo group and 15% of those in the talactoferrin group. No serious side effects were believed to be connected to the treatment with talactoferrin.
Written by Grace Rattue