Agennix AG has announced the publication of a Phase II randomized, double-blind, placebo-controlled clinical trial evaluating the Company's lead product candidate, oral talactoferrin, in first-line non-small cell lung cancer (NSCLC) in the peer-reviewed medical journal, Journal of Thoracic Oncology.
The publication, "A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oral Talactoferrin in Combination with Carboplatin and Paclitaxel in Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer" by R. Digumarti et al, appears in the June 2011 issue of the journal.
As previously reported, this study achieved its primary endpoint of improvement in confirmed response rate in the evaluable population. Supportive results were seen in the secondary endpoints of progression-free survival and overall survival. Talactoferrin appeared to be well tolerated with a statistically significant decrease in adverse events compared to placebo.
"The results from this study show the potential activity, as well as good tolerability, of talactoferrin in this clinical setting," said Rajesh Malik, M.D., Chief Medical Officer. "These data provide support for the ongoing Phase III development program with talactoferrin in non-small cell lung cancer. Our Phase III trial, FORTIS-M, evaluating talactoferrin in non-small cell lung cancer patients whose disease has progressed following two or more prior treatment regimens, completed enrollment earlier this year, and we expect top-line results from that study in the first half of 2012."
The published Phase II trial involved 110 randomized patients with previously untreated stage IIIB/IV non-small cell lung cancer and evaluated the use of talactoferrin in combination with the standard chemotherapy regimen, carboplatin plus paclitaxel, compared to placebo plus the same chemotherapy treatment.
The results showed that talactoferrin increased the confirmed response rate compared to placebo. The response rate in the 100-patient evaluable population, which was the pre-defined primary endpoint, increased from 29% (placebo) to 47% (talactoferrin) (one-tailed p-value = 0.05), meeting the pre-specified level of statistical significance for the primary endpoint.
The evaluable population was defined as patients who received at least one dose of study drug and had at least one CT scan after the start of treatment, which is necessary to determine a response rate. The response rate in the 110-patient intent-to-treat population increased from 27% to 42% (one-tailed p=0.08).
The maximum duration of treatment with talactoferrin or placebo was 18 weeks, as treatment was stopped at the same time treatment with carboplatin/paclitaxel was discontinued, even in the absence of disease progression. Median progression-free survival, overall survival, and duration of response were also longer in the talactoferrin arm, although the differences were not statistically significant.
In the study, talactoferrin appeared to be well tolerated. Patients who received talactoferrin had fewer total adverse events (two-tailed p=0.003), grade 3 or 4 adverse events (p=0.05), adverse events related to study drug or chemotherapy, incidence of serious adverse events, and discontinuations due to adverse events.
The most frequently reported adverse events occurred at comparable rates in the two arms and were consistent with those typically observed in NSCLC patients undergoing chemotherapy, including myelotoxicity (affecting bone marrow), gastrointestinal disorders, respiratory disorders and alopecia (hair loss).