An international research group including scientists from Italy, the United States, Ireland, and Israel have published a three-year analysis of the Mesothelioma (Me) drug trial, Check-Mate 743 (CM-743). The trial studied the use of the combination therapy with Nivolumab and Ipilimumab to treat this stubborn cancer arising from pleural linens and mostly related to exposure to asbestos fibers.
The project has been led by Antonio Giordano Director Sbarro Institute for Cancer Research and Molecular Medicine at Temple University, and President of the Sbarro Health Research Organization (SHRO) and affiliated as well with the University of Siena, and Luciano Mutti Professor in Oncology University of l’ Aquila . Department of Department of Applied Clinical Sciences and Biotechnology and Adj Prof of Translational Oncology attorney SHRO
Although CM-743 has prompted some regulatory bodies to approve this treatment as a front line therapy for Me, the authors had already raised serious concerns over the actual efficacy in an analysis published on JAMA Network Open in March 2022.
In this article the authors go further and not only provide the evidence that the same biases pointed out earlier still affect the three-years results of CM-743 but also scrutinize all the most recent trials conducted on Me remarking how these trials should also be considered with great caution.
“All these other trials show one or more of the biases noted in CM-743,” the authors remark, “in particular, patient selection and the sub-optimal control arm are worrisome and determine conditions that are really too far away from the clinical reality to allow any conclusions of the treatments proposed. In Italy, Ipilimumab/Nivolumab received the registration only in very selected cases,” the authors continue, “and on the basis of our analysis we are convinced that none of these treatments show any significant step forward in the fight against this tumor.”
The authors also provide evidence that not only the new treatments proposed for Me but, more generally, those proposed for many other tumors have put health systems world wide under a huge financial stress without demonstrating a comparable impact on patients’ survival.
“This evidence should be carefully considered. The cost of a treatment should be gauged on the actual benefit to patients. If a drug is approved on the basis of improved progression free survival cannot cost as much as another one that confers better survival when compared with the more effective standard treatment,” the authors conclude.
About the Sbarro Health Research Organization
The Sbarro Health Research Organization (SHRO) is non-profit charity committed to funding excellence in basic genetic research to cure and diagnose cancer, cardiovascular diseases, diabetes and other chronic illnesses and to foster the training of young doctors in a spirit of professionalism and humanism. To learn more about the SHRO please visit www.shro.org
