Phase II trial data published on Talactoferrin for treating lung cancer

Agennix AG (Frankfurt Stock Exchange: AGX) announced on Oct 11 that data from a Phase II randomised, 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.

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, will appear in the November 1, 2011 print issue of the journal. 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 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.

“There is a major need for effective, easy-to-use, well tolerated treatments for patients with refractory non-small cell lung cancer,” said Rajesh Malik, M.D., Chief Medical Officer. “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-tumour 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 published randomised 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.

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.

About talactoferrin

Talactoferrin is an oral immunotherapy that is being studied for the treatment of cancer and severe sepsis. Talactoferrin has demonstrated promising activity in randomised, double-blind, placebo-controlled Phase II studies in NSCLC and in severe sepsis. Two Phase III trials with talactoferrin in NSCLC are ongoing. The FORTIS-M trial, which completed enrollment in March 2011, is evaluating talactoferrin in NSCLC patients whose disease has progressed following two or more prior treatment regimens. A second Phase III trial – FORTIS-C – is evaluating talactoferrin in combination with the standard chemotherapy regimen, carboplatin/paclitaxel, in first-line NSCLC patients. NSCLC is one of the most common types of cancer worldwide and the most frequent cause of cancer death. Agennix is also developing talactoferrin for the treatment of severe sepsis and has initiated a Phase II/III trial, called the OASIS trial, in that indication. Talactoferrin has been shown to be very well tolerated in these patient populations.

(Source: Agennix: Journal of Clinical Oncology)