MolMed's NGR-hTNF misses in malignant pleural mesothelioma

MolMed S.p.A. (Milan:MLM) said second-line treatment with once-weekly NGR-hTNF plus best investigator's choice (BIC) missed the primary endpoint of improving overall survival (OS) vs. placebo plus BIC in the Phase III NGR015 trial to treat malignant pleural mesothelioma (MPM). BIC included best supportive care with or without chemotherapy (doxorubicin, gemcitabine or vinorelbine). The double-blind, international trial enrolled 400 patients with MPM whose disease progressed after a pemetrexed-based chemotherapy.

In a pre-specified subgroup of patients who progressed during or shortly after first-line chemotherapy, NGR-hTNF plus BIC significantly improved OS by 40% vs. placebo plus BIC. MolMed said the top-line data "provide potential to pursue conditional marketing authorization," but could not be reached for details or next steps. ...