Date: 2013-10-01
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
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: soft tissue sarcoma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On June 3, 2014, Molmed has reported, at the 50th ASCO annual meeting, that in the four-arm randomized Phase II study in sarcoma patients, the low-dose weekly NGR-hTNF plus doxorubicin regimen induced a statistically significant doubled survival time, as compared with the other schedules given at high dose in combination with doxorubicin or as monotherapy at low or high dose. The 3-year survival rate with this schedule exceeded 40% and, notably, similar results were reported for both chemo-naïve and pretreated patients, thus confirming the elevated NGR-hTNF efficacy in more aggressive, chemo-resistant disease.* On October 1, 2013, MolMed has presented at the European Cancer Congress 2013 (ECCO-ESMO-ESTRO), in Amsterdam (The Netherlands), additional data from an ongoing randomized Phase II study evaluating safety and efficacy of its investigational drug NGR-hTNF on patients suffering from soft tissue sarcomas. Data show the impact of the weekly administration of NGR-hTNF at low doses (0,8µg/sqm) in combination with doxorubicin. The new data highlighted a statistically significant doubling of the median survival associated to a favourable tolerability profile. Of particular interest is the evidence that efficacy and tolerability were similar both in patients untreated or resistant to prior treatments. This four-arm trial was designed to select the best NGR-hTNF regimen for patients with sarcomas. The primary aim of achieving a doubled three-month progression-free rate (40% vs 20%) was met by the combination of low-dose intensified NGR-hTNF (0.8 µg/sqm weekly) with doxorubicin, after both the first and the second trial stages.Preliminary data presented in June at the 49th annual meeting of the American Society of Clinical Oncology (ASCO) also show that the superiority of this regimen over the other ones in terms of progression-free survival (with a three-fold increased median duration) translated into an analogous advantage in terms ofoverall survival (with a two-fold increased median time).
