Mixed Results Reported for NGR-hTNF in Patients With Mesothelioma
Trial fails to meet primary endpoint
Mixed results have been reported from a phase III, double-blinded, placebo-controlled study of asparagine–glycine–arginine–human tumor necrosis factor (NGR-hTNF, MolMed S.p.A.) compared with best investigator choice in 400 patients with malignant pleural mesothelioma who had failed first-line chemotherapy.
Despite not meeting its primary endpoint of improving overall survival (OS), the study showed a statistically significant (unstratified P = 0.02; stratified P = 0.01) 40% improvement in OS in patients with a poorer prognosis who had progressed during or shortly after first-line chemotherapy. In addition, progression-free survival was 40% longer in the NGR-hTNF arm in patients who presented with a more aggressive, chemo-resistant disease.
NGR-hTNF is an investigational therapeutic agent for the treatment of solid tumors that demonstrates anti-tumor activity through its specific binding to blood vessels feeding the tumor mass. NGR-hTNF is being investigated in a clinical program that includes a phase III trial in malignant pleural mesothelioma (second line); a phase II trial in malignant pleural mesothelioma (first-line maintenance therapy); and five phase II trials in colorectal, lung (small-cell and non–small-cell), liver, and ovarian cancer as well as soft-tissue sarcomas.
Completed randomized studies have shown a statistically significant increase in OS in patients with squamous-cell NSCLC and soft-tissue sarcomas.
NGR-hTNF has been granted an “orphan drug” designation for the treatment of mesothelioma in the U.S.
Pleural mesothelioma develops in the tissue lining the chest cavity and is related to repeated exposure to asbestos fibers. With an incidence of approximately 1/100,000, pleural mesothelioma is still a relatively rare cancer, but incidence rates have increased during the past 20 years. The disease has a long latency period, and symptoms are non-specific. Pleural mesothelioma affects more than 10,000 people in the U.S. and Europe each year.
Source: MolMed; May 5, 2014.