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Clinical Trials

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:

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.
• Long-term follow up data of a completed Phase II trial in malignant pleural mesothelioma(ASCO abstract 7089). In this multicentre, single-arm trial, NGR-hTNF was tested as second line therapy in 57 relapsed patients, treated with the same dose of NGR-hTNF administered either every 3 weeks or every week. Long-term survival analysis confirms a strong advantage of the weekly over the tri-weekly administration schedule: the 2-year survival rate was three-fold higher considering the entire patient population and five-fold higher in patients who achieved disease control at the first tumour re-assessment. In both cohorts, patients who achieved disease control at the first tumour re-assessment and continued therapy had a double median survival time with respect to patients who progressed at the first tumour re-assessment and consequently discontinued treatment (16.7 v 8.3 months).
Evaluation of the weekly schedule of NGR-hTNF for the treatment of chemo-pretreated malignant pleural mesothelioma patients is currently being investigated in a double-blind, placebo-controlled randomised Phase III trial. Moreover, based on the long-term effect of the drug in disease control, MolMed announces the start of a randomised, placebo-controlled Phase II trial as first line maintenance treatment for patients who completed the pemetrexed-based chemotherapy. The trial is planning to enrol 100 patients and will investigate the effects of the administration of NGR-hTNF in prolonging the benefits attained with chemotherapy; the primary endpoint of the trial is progression-free survival.

Is general: Yes