NGR-hTNF: Phase III data
Top-line data from the double-blind, international Phase III NGR015 trial in 400 patients with MPM whose disease progressed after a pemetrexed-based chemotherapy showed that second-line treatment with once-weekly 0.8 µg/m 2 NGR-hTNF plus best investigator's choice (BIC) missed the primary endpoint of improving OS vs. placebo plus (p>0.05). BIC included best supportive care with or without chemotherapy (doxorubicin, gemcitabine or vinorelbine). 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 (p=0.02). MolMed defined the subgroup as patients with a treatment-free interval of about 5 months after first-line chemotherapy, which was the median treatment-free interval for the overall study population. NGR-hTNF plus BIC also improved PFS by 40% vs. placebo plus BIC in the subgroup. MolMed said the top-line data "provide potential to pursue conditional marketing authorization," but declined to disclose details or next steps. ...