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Emerging Therapy Watch: NGR-hTNF for MPM, Phase III Trial

An emerging therapy known as NGR-hTNF has entered an ongoing phase III trial that has nearly 400 participants at 49 hospitals and research centers around the world. NGR-hTNF 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.

The main objective of the NGR-hTNF trial is to document the efficacy of the substance 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.

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,” says ClinicalTrials.gov. 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 (Adriamycin, Rubex)
  • Gemcitabine (Gemzar)
  • Vinorelbine (Navelbine)


Though the NGR-hTNF study is now classified as “ongoing,” it is not currently recruiting participants. However, if it passes phase III, this promising treatment could become available in the near future.



Sources

"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.