the WINTHER trial

The WINTHER trial: Sheba Medical Center and International Partners Conquer a New Frontier in the Fight Against Cancer

The collaboration of elite medical researchers from Sheba and six international partners pioneered the path for a new, revolutionary cancer treatment. For the first time ever, these researchers conducted a successful clinical trial using genomic and transcriptomic profiling (RNA expression testing) to advance precision cancer medicine. This clinical trial, called the WINTHER trial, was designed by the WIN Consortium, and one of the lead researchers is Prof. Raanan Berger, MD, PhD, Director of Oncology at Sheba.

The WINTHER trial reveals that using a combination of RNA profiling and DNA alterations testing can match personalized therapies to more patients suffering with advanced cancer than only using DNA profiling for tumor mutations. By implementing transcriptomics that are based on a greater expression of RNA in tumors than in normal tissues, the WINTHER trial succeeded in tailoring precision medicine for a larger number of patients.

rannan new

Raanan Berger, M.D, Ph.D, is the Director of the Cancer Center

“This international collaboration has conquered a new medical frontier in the realm of precision oncology,” said Prof. Raanan Berger. “The success of this clinical trial’s application of RNA to create personalized treatments for a greater number of advanced cancer patients shows great promise for the future.”

A total of 303 patients were enrolled in WINTER, and ultimately, 107 patients who had already received intense treatments for advanced cancer were treated in the WINTHER trial. An international committee of cancer experts determined who was a candidate for participation. Approximately 25% of the patients in the trial had already been treated previously with a minimum of five types of therapies.

During the clinical trial, 69 patients were given treatments based on DNA mutation profiling, and 38 patients were given RNA profiling treatments. At the end of the trial, the results showed that 35% of the patients were matched successfully with personalized therapy. In contrast, earlier studies did not demonstrate as high of a success rate in matching. The WINTHER researchers demonstrated the safety and efficacy of using RNA expression and normal tissue biopsy to customize therapy options for patients.

clinical trial using genomic and transcriptomic profiling

“Importantly, our results show that patients treated with a drug or regimen more closely matched to the molecular profile of their tumor, do better,” said Razelle Kurzrock, co-leader of the WINTHER trial and Director of UCSD Moores Center for Personalized Cancer Therapy.

Along with Prof. Berger from Sheba, the skilled team responsible for conducting the WINTHER trial included researchers from: Vall d’Hebron Institute of Oncology – VHIO, in Spain; Gustave Roussy, in France (Jean-Charles Soria); Centre Léon Bérard, in France (Pierre Saintigny); Segal Cancer Centre, McGill University, in Canada (Wilson H. Miller); UT MD Anderson Cancer Center, in the USA (Jordi Rodon and Apostolia-Maria Tsimberidou); and University of California San Diego, Moores Cancer Center, in USA (Razelle Kurzrock).