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Updated 2-THE-TOP Data Suggest Improvements in Progression-Free Survival, Overall Survival Compared to Matched-Control Patients from EF-14 Trial
Patients in phase 2 pilot trial 2-THE-TOP had median progression-free survival of 12.1 months compared with 7.9 months for matched-control patients from
About this update from Novocure Limited
[{"type":"text","content":"\nPatients in phase 2 pilot trial 2-THE-TOP had median progression-free survival of 12.1 months compared with 7.9 months for matched-control patients from EF-14\n\n ST. HELIER, Jersey--(BUSINESS WIRE)--\nNovocure (NASDAQ: NVCR) today 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).\n\nThese 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).\n\nOf the 15 patients in 2-THE-TOP with measurable target lesions, six (40%) achieved partial to complete response and eight (53%) had stable disease.\n\n“These data from 2-THE-TOP are exciting and point to the potential benefit of Tumor Treating Fields together with pembrolizumab and temozolomide,” said Uri Weinberg, Novocure’s Chief Science Officer. “TTFields’ ability to activate a downstream immune response, effectively turning a cold tumor hot, is a unique element of TTFields therapy.”\n\nDr. Tran will present his data from 2-THE-TOP at the 6th Quadrennial Meeting of the World Federation of Neuro-oncology Societies (WFNOS 2022) in Seoul, South Korea on March 26, 2022. His oral presentation, which has been selected for a Best Abstract Award, will be delivered during the conference’s Top 10 Session 2 at 10:15 a.m. KST, followed by a live question-and-answer session.\n\nIn 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...