Development of targeted therapies and precision medicine
The SHIVA02 study follows the encouraging results of the SHIVA01 study presented at ASCO in 2015 and published in Lancet Oncology in September 2015. The project aims to explore a new research methodology based on the molecular profile of tumors in the prospect of defining personalized treatments for patients with a therapeutic impasse. The objective of SHIVA02 is to continue work to evaluate the effectiveness of targeted treatments against cancer in the presence of molecular alterations detected by high-throughput sequencing.
SHIVA02 will cover all types of patients with metastatic or recurrent tumors, and refractory to standard treatments. It is planned to include 370 patients over 2 years. The genetic map (or molecular profile) of the tumor will be established for each patient. If a relevant molecular alteration has been detected, patients in whom conventional therapy does not work or more will benefit from the corresponding targeted therapy. The effectiveness of the approach will be assessed by comparing the efficacy of the two treatments on each patient.
The SHIVA02 study will be led by Professor Christophe Le Tourneau, responsible for early trials and precision medicine at the Institut Curie, and carried out in collaboration with the Léon Bérard Center in Lyon.
"The Institut Curie continues to develop precision medicine, a real hope for patients with cancer. We have been pioneers in this field thanks to the SHIVA01 study, which suggested the interest of a therapeutic choice based more on the genetic abnormality of the tumor than on its anatomical localization. This path is open and we continue to explore it with SHIVA02. The number of our patients included in clinical studies is constantly increasing and the developments of molecular biology place us at the head of the establishments likely to propose early and promising tests to our patients. "Adds Professor Thierry Philip, President of the Institut Curie.
"Nobody has yet been able to demonstrate the concept of precision medicine in oncology, that is, determining the treatment of patients in a customized way according to the genetic map of their tumor. The SHIVA01 test, however, provided enough evidence to suggest that this strategy is right. SHIVA02 is built on the basis of what we learned in SHIVA01. We are therefore hopeful to prove that precision medicine is one of the pillars of tomorrow's oncology medicine, "explains Professor Christophe Le Tourneau.
"Through this partnership, MSDAVENIR pursues its mission of active support to French medical research and to our greatest institutes, recognized for the excellence of their work. By studying the efficacy of treatments developed from the molecular profile of each tumor, the Curie Institute is shaking up clinical research in oncology. The SHIVA02 study, which aims to confirm very encouraging first results, points to further major advances towards a truly personalized cancer medicine. This partnership is the eighth research project supported by MSDAVENIR since its launch a year ago. It confirms the concrete reinforcement of links between research institutes and laboratories, of which patients are the main beneficiaries " Cyril Schiever, Chairman of the Board of Directors of MSDAVENIR.