Novocure announced that Dr. David Tran, Chief of the Division of Neuro-Oncology at the McKnight Brain Institute at the University of Florida, will present updated results from his investigator-initiated phase 2 pilot 2-THE-TOP clinical trial testing the safety and preliminary efficacy of Tumor Treating Fields (TTFields) together with pembrolizumab and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma (GBM). These preliminary results, which are based on a median follow-up time of 16.8 months, compare outcomes for 26 patients in the ongoing 2-THE-TOP trial versus a historical, matched-control group of 26 patients from the TTFields plus temozolomide arm of the phase 3 pivotal EF-14 clinical trial. For patients in the 2-THE-TOP trial, median progression-free survival was 12.1 months, compared with 7.9 months for the matched-control patients in EF-14 (hazard ratio=0.46, p=0.033).

Patients in 2-THE-TOP had a median overall survival of 25.2 months, compared with 15.9 months for the matched-control patients in EF-14 (hazard ratio=0.38, p=0.020). Of the 15 patients in 2-THE-TOP with measurable target lesions, six (40%) achieved partial to complete response and eight (53%) had stable disease. In a preclinical study published in the Journal of Clinical Investigation (JCI) on Feb.

24, 2022, Dr. Tran's research group reported that TTFields-mediated cell disruption activates the immune system, triggering an anti-tumor cell response that may be effectively used together with existing immunotherapy approaches in the treatment of solid tumors with limited systemic toxicity. These preclinical findings provided the mechanistic rationale for the 2-THE-TOP study. Dr. Tran's oral presentation at WFNOS 2022 is one of three oral presentations at the conference highlighting research on TTFields.

Dr. Carsten Hagemann of the Department of Neurosurgery at University Hospital Würzburg will present preclinical data on TTFields as a novel chemotherapeutic delivery strategy on March 25, 2022 at 17:30 KST. Dr. Wenyin Shi, Co-Director of the Brain Tumor Center of the Sidney Kimmel Cancer Center, will present data from the SPARE trial: Scalp sparing radiation with concurrent temozolomide and TT Fields (200 kHz) for patients with newly diagnosed glioblastoma on March 26, 2022 at 18:00 KST. In addition, 28 posters at WFNOS 2022 will feature research on TTFields.

TTFields is investigational for the treatment of newly diagnosed GBM when used together with pembrolizumab.