The investigational immunomodulatory agent talactoferrin boosts survival compared to placebo in multiple prognostically important subsets of patients with non-small cell lung cancer (NSCLC) who have failed first- or second-line therapy, according to phase II data released at the 2011 American Society of Clinical Oncology (ASCO) meeting.

P. M. Parikh, MD, with the Indian Cooperative Oncology Network in Mumbai, and colleagues randomized 100 patients with stage IIIB/IV NSCLC to oral talactoferrin, 1.5 g bid, or placebo on top of best supportive care. All patients had failed first- or second-line chemotherapy.

Talactoferrin is a recombinant human lactoferrin that is a member of the transferrin family of iron-binding glycoproteins. Lactoferrins have multiple known biological activities including cancer protection, cellular growth and differentiation, and antimicrobial and anti-inflammatory properties.

Talactoferrin was administered for a maximum of three, 14-week cycles during which the agent was administered for 12 consecutive weeks followed by a two-week off period.
v The primary endpoint was overall survival (OS) in the intent-to-treat population.

Results showed that the study achieved its primary endpoint with a 65% increase in OS in talactoferrin-treated patients (3.7 months for placebo versus 6.1 months for talactoferrin, HR=0.68).

The OS benefit of talactoferrin was maintained when patients were stratified by age, histology, disease stage, line of therapy, and ECOG performance status.

Activity was observed with both squamous and non-squamous NSCLC.

The investigators emphasize that the findings need to be replicated in the 742-patient, phase III FORTIS-M study, which completed enrollment in March. Top-line results are expected by mid-2012.

According to the American Cancer Society, NSCLC is responsible for nearly 90% of all newly diagnosed lung cancer cases in the U.S. More than 50% of NSCLC cases are already metastatic and incurable when diagnosed. Currently, the five-year survival rate in the U.S. is roughly 15%.

The study, which was conducted at 11 centers throughout India, was sponsored by Agennix, Inc.

Jill Stein
Jill Stein is a Paris-based freelance medical writer.