Emerging MPM Therapy NGR-hTNF in Ongoing Phase III Trial
If a drug or therapy has entered a phase III clinical trial, researchers have determined that it is effective and potentially safe. A phase III clinical trial recruits a large group of people to further evaluate the drug’s effectiveness and to monitor side effects, compare the drug to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Some drugs that enter this phase will move forward to a final phase IV study. Phase IV studies are done after the drug or treatment has been marketed in order to gather information on the drug's effect in various populations and any side effects associated with long-term use.
Advancing beyond phase I and II trials is truly an accomplishment for new and emerging treatments as all new drugs and treatments must undergo rigorous testing before they are approved to enter any type of clinical trial involving people. Many drugs and treatments never make it this far. This is especially true of drugs that are currently being tested to help treat rare cancers such as mesothelioma. Well, it looks like an emerging therapy known as NGR-hTNF has made it this far. In fact, the therapy is in an ongoing phase III trial that has nearly 400 participants at 49 hospitals and research centers around the world.
The main objective of the trial is to document the efficacy of NGR-hTNF administered at low doses weekly in advanced malignant pleural mesothelioma (MPM) patients previously treated with a pemetrexed-based chemotherapy regimen. Currently, there are no regulatory-approved or widely accepted treatment options for MPM patients failing a standard pemetrexed-based chemotherapy regimen.
Per ClinicalTrials.gov, the study aims to show “a superior efficacy in terms of overall survival duration of NGR-hTNF 0.8 µg/mq weekly, plus BIC versus placebo plus BIC in advanced MPM patients progressing after a standard pemetrexed-based chemotherapy.” BIC refers to “Best Investigator’s Choice,” meaning, one of the following single-agent chemotherapy drugs might be administered in combination with NGR-hTNF:
- Doxorubicin (trade names Adriamycin, Rubex): 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
- Gemcitabine (Gemzar): 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
- Vinorelbine (Navelbine): 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
NGR-hTNF is listed as an emerging treatment in the United States Malignant Mesothelioma Report 2017 - Market Insights, Epidemiology and Market Forecast 2010-2023. It is defined by the National Cancer Institute (NCI) as a substance that is made by linking tumor necrosis factor (TNF) to a peptide. The peptide binds to tumor blood vessels, and TNF damages them. Also called “tumor vasculature–targeted tumor necrosis factor alpha” NGR-hTNF is a type of biological response modifier.
Though the NGR-hTNF study is now ongoing, it is not currently recruiting participants. The good news is, if it passes phase III, NGR-hTNF could become available in the coming years.
"FAQ: ClinicalTrials.gov - Clinical Trial Phases." U.S. National Library of Medicine. National Institutes of Health (NIH), 18 Apr. 2008. Web. 29 Mar. 2017.
"Malignant Mesothelioma - Market Insights, Epidemiology and Market Forecast - 2023 - United States." Research and Markets. Research and Markets, Jan. 2017. Web. 29 Mar. 2017.
"NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed." ClinicalTrials.gov. U.S. National Institutes of Health (NIH), 30 Mar. 2017. Web. 31 Mar. 2017.
"NGR-TNF." National Cancer Institute (NCI). U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), n.d. Web. 29 Mar. 2017.