Health economics and outcomes research showed post-Stupp therapeutic developments, including TTFields, significantly increase overall survival in a large commercially insured population
The largest safety dataset to date of more than 23,000 patients reinforced that TTFields therapy is well-tolerated in patients with high-grade gliomas
Novocure (NASDAQ: NVCR) today announced 25 abstracts on Tumor Treating Fields (TTFields) therapy will be featured at the Society for Neuro-Oncology (SNO) 2022 Annual Meeting from Nov. 16 to Nov. 20 in Tampa. The presentations cover a broad range of topics, including TTFields’ multimodal mechanism of action, safety and tolerability, and health economics and outcomes research (HEOR).
New research in HEOR includes an analysis by a coalition of researchers at Central Brain Tumor Registry of the United States (CBTRUS), Duke University and the National Cancer Institute that utilized commercial claims and population-based datasets to better understand potential treatment factors associated with improved survival for glioblastoma (GBM) (Corey Neff, M.P.H., Department of Neurosurgery, Duke University School of Medicine in Durham, North Carolina, et al.) The presentation, “Improvements in survival for glioblastoma in the post-Stupp protocol era,” showed that survival in GBM has continued to improve over time in the post-Stupp protocol era, which may be due to developments of new therapeutic approaches. The analysis showed post-Stupp therapeutic developments, including TTFields, significantly increase overall survival in the commercially insured population. Of the 19,414 identified adult patients with GBM, 3,061 used TTFields therapy. These patients experienced an extended median overall survival compared to patients who were not treated with TTFields (17.6 months versus 13.1 months, respectively; hazard ratio: 0.77; P<0.001).
A presentation by Maciej M. Mrugala, M.D., Ph.D., M.P.H., Director of the Neuro-Oncology Program at the Mayo Clinic College of Medicine and Science in Phoenix, analyzed post-market safety data from more than 23,000 high-grade glioma patients who received TTFields therapy in the last decade, representing the largest safety dataset to date. These global real-world data reinforced the findings from our EF-14 phase 3 pivotal study that TTFields therapy is well-tolerated in GBM patients, with no new safety signals identified. There were no observed differences by type of GBM diagnoses and by age subgroups. These data are consistent with previous findings in that TTFields therapy is not associated with added systemic toxicity; localized skin irritation is the most common adverse event and can be managed with appropriate prophylaxis and treatment strategies.
A presentation highlighting TTFields therapy as a treatment for newly diagnosed GBM includes the first results of the PriCoTTF phase 1/2 study, which met its primary endpoint demonstrating the safety and tolerability of TTFields concomitant with radiotherapy, presented by Sied Kebir, M.D., Deputy Head of the Division of Clinical Neurooncology at University Medicine Essen in Germany.
Josef Vymazal, M.D., Deputy Director of Na Homolce Hospital in Prague, will present data from 18 years of clinical practice experience with newly diagnosed GBM patients. Patients who received TTFields therapy demonstrated improvements in progression free survival and overall survival compared to controls (hazard ratio: 0.55, P=0.006; and 0.61, P=0.027 respectively). This is one of several extensive studies assessing survival outcomes in newly diagnosed GBM patients treated with TTFields therapy conducted at a single center to date.
“We are honored and proud of the volume and depth of TTFields research featured at the SNO 2022 Annual Meeting,” said Frank Leonard, President of Novocure’s U.S. CNS (central nervous system) Cancers Franchise. “Over the last 15 years, SNO has been an important meeting for Novocure as Tumor Treating Fields therapy has become ingrained within the neuro-oncology community and as our science continues to evolve. We look forward to gathering and participating in this essential scientific exchange for the advancement of neuro-oncology.”
All poster presentations will occur from 7:30 p.m. to 9:30 p.m. EST Friday, Nov. 18, in West/Central Hall.
(INNV-10) Overcoming challenges and optimizing patient outcomes with Tumor Treating Fields (TTFields) therapy. Lead author and presenter: P. Gage Gwyn.
(INNV-07) Tumor Treating Fields (TTFields; 200 kHz) post-marketing safety data from patients with glioblastoma treated between 2011–2022. Lead author and presenter: Maciej M. Mrugala.
(INNV-11) Eighteen Years of Experience with Treatment of Glioblastoma Using Tumor Treating Fields (TTFields) in Newly Diagnosed Glioblastoma (ndGBM) in a single center. Lead author and presenter: Josef Vymazal.
(NCOG-22) TIGER PRO-Active Study: Investigating daily activity, sleep and neurocognitive functioning in glioblastoma patients applying TTFields therapy in Germany in Routine Clinical Care. Lead author: Martin Glas. Presenter: Sied Kebir.
(RADT-17) A case of recurrent glioblastoma effectively treated with tumor-treating-fields. Lead author and presenter: Xin Geng.
(INNV-22) A case report of multiple lesions disappearing after TMZ+TTFields+ Darafenib and trametinib in a patient with GBM. Lead author and presenter: Boning Cai.
(INNV-30) Retrospective analysis of TTFields in patients with HGG based on the criteria of 2021 WHO CNS5. Lead author: Xiaoyan Yang. Presenter: Feng Wang.
(RADT-18) Particle Beam Radiation Therapy plus Tumor Treating Fields in the Treatment of Newly Diagnosed WHO Grade 4 Gliomas: An Early Result of Phase 2 Single-arm Trial. Lead author and presenter: Xianxin Qiu.
(CTNI-47) Tumor Treating Fields Combine with Temozolomide for Newly Diagnosed Glioblastoma: A Retrospective Analysis of Chinese Patients. Lead author: Chunjui Chen. Presenter: Zhiyong Qin.
(CTIM-05) Final results of 2-THE-TOP: a pilot phase 2 study of TTFields (Optune) plus pembrolizumab plus maintenance temozolomide (TMZ) in patients with newly diagnosed glioblastoma (ndGBM). Lead author and presenter: David D. Tran. (Abstract only)
(CTNI-29) Investigating safety and efficacy of TTFields prior and concomitant to radiotherapy in newly diagnosed glioblastoma - first results of the PriCoTTF phase I/II trial. Lead author: Martin Glas. Presenter: Sied Kebir.
(INNV-09) Impact of Molecular markers on treatment outcome of Glioblastoma patients treated with concurrent Tumor-Treating Fields (TTF) and chemoradiation: secondary analysis of SPARE trial. Lead author and presenter: Louis Cappelli.
(RADT-19) Chemoradiation (CRT) treatment with or without concurrent Tumor-Treating Fields (TTFields) in patients with newly diagnosed glioblastoma (GBM). Lead author and presenter: Louis Cappelli.
(CSIG-41) Sensitizing cancer cells to Tumor Treating Fields (TTFields) by Inhibition of PI3K. Lead author: Anat Klein-Goldberg. Presenter: Moshe Giladi.
(DNAR-10) The efficacy of temozolomide and lomustine in glioblastoma cell lines may be enhanced by concomitant treatment with Tumor Treating Fields (TTFields). Lead author: Hila Fishman. Presenter: Moshe Giladi.
(EXTH-72) TTFields enhance the antineoplastic activity of the drug-repurposing approach CUSP9v3 in glioblastoma in vitro. Lead author: Qiyu Cao. (Abstract only)
(CCRG-04) Targeting the cell-cycle effects of Tumor Treating Fields (TTFields) to increase its efficacy. Lead author: Paul L.G. Slangen. Presenter: Gerben R. Borst.
(DNAR-12) Combining Tumour Treating Fields with therapeutic DNA damage response inhibitors to increase potency in high-grade glioblastomas using clinically relevant ex-vivo glioma stem cell models. Lead author: Aurelie Vanderlinden. Presenter: Ola Rominiyi.
(MODL-07) Sensitivity of Tumor Treating Fields (TTFields) treatment planning to tumor segmentation errors. Lead author: Oshrit Ze’evi. Presenter: Eyal Abend.
(MODL-13) Sensitivity of Tumor Treating Fields (TTFields) treatment planning to healthy tissue segmentation inaccuracies. Lead author: Oshrit Ze’evi. (Abstract only)
(MODL-21) Efficacy of different layouts in treating infratentorial tumors with Tumor Treating Fields (TTFields). Lead author: Ariel Naveh. (Abstract only)
(EXTH-05) Toward 100% clinical efficacy for tumor-treating fields. Lead author and presenter: Kristen W. Carlson.
(NIMG-69) Prediction of Progression-Free Survival in Patients with Primary Glioblastoma: MRI T2 Relaxivity and Deep Learning. Lead author and presenter: Aaron Rulseh
HEALTH ECONOMICS AND OUTCOMES RESEARCH
(QOL-21) Real-world quality-of-life and health utilities for patients with CNS cancers on the XCELSIOR platform. Lead author: Sarah Ginn. Presenter: Gordon V. Chavez.
(EPID-06) Improvements in survival for glioblastoma in the post-Stupp protocol era. Lead author: Corey Neff. Presenter: Quinn T. Ostrom.
About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfieldstherapy.com.
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and malignant pleural mesothelioma. Novocure has ongoing or completed clinical studies investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.
Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 24, 2022, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.