Date: 2011-05-26
Type of information:
phase: 2
Announcement: results (publication of the article “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, in the June 2011 issue of the Journal of Thoracic Oncology)
Company: Agennix (Germany)
Product: 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: non-small cell lung cancer
Therapeutic area: Cancer Oncology
Country:
Trial details: 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.
Latest
news: Agennix 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. 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 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).
