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: non-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 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 confirm the favourable safety profile as well as the promising antitumour activity of NGR-hTNF.
• First results of a randomised Phase II trial of NGR-hTNF in combination with cisplatin-based chemotherapy as first-line treatment for non-small cell lung cancer (ASCO abstract 7568). This ongoing trial is investigating the impact of NGR-hTNF in combination with cisplatin-based chemotherapy. So far, 80 patients have been assessed for safety and preliminary antitumour activity. As far as safety is concerned, there were no pulmonary haemorrhage or bleeding events, which have been commonly associated with the use of antiangiogenic agents in patients with squamous histology. First data on clinical activity are promising; there is evidence of improved activity in terms of disease control and duration of progression-free survival in patients either with squamous or non-squamous histology who continued treatment with NGR-hTNF alone as maintenance therapy after completion of chemotherapy, thus confirming the effect of NGR-hTNF in long-term disease control. Recruitment of the trial will continue beyond the planned population of 102 patients in order to ensure the inclusion of an appropriate number of patients with squamous cell histology for a complete primary analysis of this tumour variant.
