Date: 2011-06-03
Type of information: Interim results
phase: 2
Announcement: interim results
Company: MolMed (Italy)
Product: NGR-hTNF
Action
mechanism: NGR-hTNF is a vascular targeting agent with unique mode of action, and a first-in-class compound in the class of peptide/cytokine complexes able to selectively target the tumour vasculature. It consists of a tumour homing peptide (NGR) that selectively binds tumour blood vessels, fused to the human cytokine TNF. NGRhTNF is undergoing clinical development both as monotherapy and in combination therapy, in a total of seven indications.
Disease: relapsed small-cell lung cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details:
Latest
news: MolMed has reported new clinical data of its investigational anticancer drug NGR-hTNF in three different lung cancer indications, which will be presented on 4 June at the 47th ASCO Annual Meeting in Chicago. Initial analysis of a randomised Phase II trial in non-small cell lung cancer, along with top line results of a Phase II trial in small-cell lung cancer and long-term follow up of a Phase II trial in mesothelioma, confirm the favourable safety profile as well as the promising antitumour activity of NGR-hTNF.
• Top-line results of a Phase II trial of NGR-hTNF in combination with doxorubicin for the treatment of relapsed small-cell lung cancer (ASCO abstract 7077). The trial enrolled 28 patients: over half of the patients showed disease control, with similar antitumour activity in terms of disease regression in both chemo-sensitive and chemo-refractory patients. One third of patients were progression-free at six months and alive at 1-year, with prolonged clinical benefit observed also in patients heavily pre-treated with two or more prior therapies. Additionally, we observed a double survival time in patients presenting a low Neutrophil to Lymphocyte Ratio (8.4 months) as compared to patients with high ratio (4.6 months). This biological index indirectly confirms the role of the effector immune system in the NGR-hTNF mechanism of action.
