WIN Consortium (WIN) has received the US Food and Drug Administration (FDA)'s approval to start clinical trials of a novel therapeutic approach using a combination of three targeted therapies for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC).
With more than 60 percent of NSCLC detected in an advanced or metastatic stage, and less than 5% living after five years, a paradigm changing strategy for treating the deadliest cancer is needed.
WIN Consortium is a French based non-profit network of 41 world-class academic medical centers, industries (pharmaceutical and diagnostic companies), health payer, research organizations and foundation and patient advocates spanning 17 countries and 4 continents, aligned to deliver now the progress in cancer treatment that is awaited by so many patients and families around the world.
WIN's concept relies on a tri-therapy combination of targeted drugs, similar to AIDS and tuberculosis treatment, which are expected to be highly potent when used together.
"It is important to acknowledge a significant difference between cancer and AIDS. In AIDS, one tri-therapy combination is effective for a majority of patients, whereas in cancer it is expected that many combinations will be needed to treat all patients effectively," said Dr. John Mendelsohn, Chairman of WIN Consortium. "The Consortium has developed new technologies for tailoring combinations for each individual patient.''
“WIN's trial, entitled SPRING, is therefore a first proof-of-concept of this novel approach in the treatment of lung cancer, and, as a first combination, will test three drugs from WIN's big pharma members, Merck Serono's Avelumab combined with Pfizer's Palbociclib and Axitinib,'' added Dr. Mendelsohn.
The SPRING trial will start with a Phase I portion to explore the safety of the combination and determine the optimal doses for the Phase II that will explore the efficacy of this tri-therapy regimen in first line treatment of metastatic NSCLC. The trial will also aimto validate a novel algorithm SIMS (Simplified Interventional Mapping System) developed by WIN and designed to match each patient's tumor biology to a specific drug combination.
BGU's Dr. Eitan Rubin will be responsible for testing and implementing the SIMS algorithm and for all data collection over the course of the clinical trials. Dr. Rubin is a member of the Shraga Segal Department of Microbiology, Immunology and Genetics in the Faculty of Health Sciences. Prof. Angel Porgador is BGU's representative on the WIN Directorate.
Both tumor and normal lung tissue biopsies will be obtained in the SPRING trial to validate the algorithm.
