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2-THE-TOP Phase 2 Trial Reports Positive Top-Line Results in Newly Diagnosed Glioblastoma
Median progression-free survival was at least 11.2 months in patients with greater than 9 months of follow-up Partial or complete response was detected in
About this update from Novocure Limited
[{"type":"text","content":"\nMedian progression-free survival was at least 11.2 months in patients with greater than 9 months of follow-up\n\nPartial or complete response was detected in 24% of patients\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, has released updated data from the phase 2 pilot 2-THE-TOP trial testing the safety and efficacy of Tumor Treating Fields (TTFields) together with pembrolizumab and temozolomide for the treatment of adult patients with newly diagnosed glioblastoma (GBM). In patients with greater than 9 months of follow-up, median progression-free survival, the primary endpoint, was at least 11.2 months. 24% of patients achieved partial to complete response. Dr. Tran will present these data at the Society for Neuro-Oncology (SNO) 2021 Annual Meeting in Boston on November 19, 2021.\n\n“These data show that Tumor Treating Fields have the potential to activate the pathways needed to create an effective, anti-cancer environment in the tumor,” said Dr. Ely Benaim, Novocure’s Chief Medical Officer. “The results published today suggest a potential paradigm shift in how we approach treatment of patients with newly diagnosed glioblastoma.”\n\n“We are very encouraged by the results of the 2-THE-TOP study, especially in light of the poor prognostic factors of the patient population,” said William Doyle, Novocure’s Executive Chairman. “Dr. Tran’s research is an important continuation of our exploration of synergies between TTFields and immunotherapy agents. We would like to thank Dr. Tran and the patients enrolled in the 2-THE-TOP trial for their ingenuity and courage.”\n\nTwenty-five patients with a median age of 61 years were enrolled in the 2-THE-TOP study, with a median follow-up of 14.7 months. Eight (32%) had biopsy only and partial resection, respectively. Eighteen (72%) had unmethylated MGMT and 3 (12%) had an IDH mutation. Twelve (48%) were progression-free, and 15 (60%) were still alive. Of the 19 patients with follow-up greater than 9 months, the median progression-free survival was at least 11.2 months compared to 6.7 months from the historical control study, EF-14, in which patients received TTFields and adjuvant temozolomide. Six (24%) patients with measurable tumors ac...