28 of 38 abstracts were prepared by external researchers, representing increasing interest in Novocure’s proprietary therapy
The long-term analysis of all 695 patients enrolled in its phase 3 pivotal trial in newly diagnosed GBM which confirms the superior progression free and overall survival seen in the trial’s interim analysis and demonstrates superior two, three and four year survival of patients treated with Optune® together with temozolomide will also be presented
ST. HELIER, Jersey--(BUSINESS WIRE)-- Novocure (NASDAQ:NVCR) announced today that 38 abstracts focusing on Tumor Treating Fields (TTFields) will be presented at the 21st Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) on Nov. 17-20, in Scottsdale, Arizona. Of the 38 abstracts, 28 were prepared by external researchers, representing a growing interest in Novocure’s proprietary TTFields therapy.
“Every year at the SNO annual meeting, we observe an increased interest in TTFields, as is evident from a growing number of abstracts accepted along with an increasing number of institutions that are studying TTFields,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “Research conducted by external scientists strengthens our understanding of TTFields, often validating TTFields as a potential treatment for a number of solid tumors.”
Abstracts span a variety of topics from preclinical and clinical data to treatment delivery and patient education. Notable topics to be presented include, amongst others, TTFields in combination with immunotherapy, radiation, triple chemotherapy and cytostatic agents, a case report on the use of TTFields in brain metastasis from ovarian cancer and a pilot study of Optune for recurrent atypical and anaplastic meningioma.
The long-term survival analysis of the full dataset from its phase 3 pivotal EF-14 trial of Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) will be presented on Friday, Nov. 18, by Roger Stupp, M.D., Professor at the University of Zurich and Director of Department of Oncology at the Zurich University Hospital, Zurich, Switzerland, and EF-14 Principal Investigator. The long-term analysis confirms the interim analysis results published in the Journal of the American Medical Association (JAMA)1 in December 2015, showing significant extension of both progression free and overall survival in newly diagnosed GBM patients receiving Optune with temozolomide compared to temozolomide alone. The long-term analysis shows survival rates were significantly higher four years from randomization in patients receiving Optune with temozolomide compared to patients receiving temozolomide alone. The safety profile in the long-term analysis was consistent with the interim analysis of the EF-14 trial.
The following abstracts will be presented:
Human glioma cell migration and invasion properties are inhibited by exposure to tumor treating fields (TTFields) in vitro; RS Schneiderman et al; Saturday, Nov. 19; abstract: #EXTH-03
Tumor treating fields (TTFields) induce autophagy in glioma cells; Y Porat et al; Saturday, Nov. 19; abstract: #EXTH-30
Effects of tumor treating fields (TTFields) and temozolomide in MGMT expressing and non-expressing patient-derived glioblastoma cells; PA Clark et al; Saturday, Nov. 19; abstract: #EXTH-25
Tumor Treating Field (TTFields) effects on glioblastoma cells are augmented by mitotic checkpoint inhibition; AF Kessler et al; Saturday, Nov. 19; abstract: #EXTH-07
Cytostatic agents combined with tumor treating fields (TTFields) in glioma cell lines; M Groves et al; Saturday, Nov. 19; abstract: #NIMG-39
Tumor cells induce immune activation phenotype in immune cells following TTFields activation; T Holtzman et al; Friday, Nov. 18; abstract: #IMST-26
Evaluating the in-vitro effects of tumor treating fields on T cell responses; G Diamant et al; Friday, Nov. 18; abstract: #IMST-30
METIS: A phase III study of radiosurgery with TTFields for 1-10 brain metastases; M Mehta et al; Saturday, Nov. 19; abstract: #BMET-03
One year with Optune® in routine use: first report on clinical experiences in Germany; M Misch et al; Friday, Nov. 18; abstract: #RARE-44
Analysis of glioblastoma physical characteristics in patients benefiting from tumor treating electric fields therapy; PP San et al; Friday, Nov. 18; abstract: #RTHP-19
Compliance and duration of treatment with tumor treating fields (TTFields) in adjuvant treatment for newly diagnosed glioblastomas (GBMs) improves progression-free survival (PFS) and overall survival (OS); SA Jeyapalan et al; Friday, Nov. 18; abstract: #RTHP-29
Pilot study of Optune (Novo-TTF-100A) for recurrent atypical and anaplastic meningioma; G Wu et al; Friday, Nov. 18; abstract: #ACTR-43
Classification of dermatologic adverse events and management strategies in patients receiving therapy with Optune for high grade gliomas; D Jennings et al; Friday, Nov. 18; abstract: #QLIF-11
The use of a programmable shunt in a patient, treated with Optune: feasibility report; L Schreiber et al; Friday, Nov. 18; abstract: #RARE-24
Survival benefit with triple chemotherapy and TTFields for glioblastoma; G Lu et al; Friday, Nov. 18; abstract: #PDCT-16
Patterns of glioblastoma recurrence in low field intensity regions during TTFields treatment; J Battiste et al; Saturday, Nov. 19; abstract: #NIMG-61
Patterns of compliance in the use of tumor treating fields (Optune) for brain tumors; M Pandey et al; Friday, Nov. 18; abstract: #ACTR-31
Use of tumor treating fields in brain metastases from ovarian cancer, a case report; M Pandey et al; Saturday, Nov. 19; abstract: #BMET-21
Imaging the early metabolic response during tumor treating fields (TTFields) therapy in recurrent glioblastoma; C Juhasz et al; Saturday, Nov. 19; abstract: #NIMG-37
Rates and impact of compliance with tumor treating fields therapy in a glioma cohort; Y Odia et al; Friday, Nov. 18; abstract: #RTHP-37
Rates and outcomes of combination tumor treating fields and immunotherapy in a glioma cohort; Y Odia et al; Friday, Nov. 18; abstract: #ATIM-34
A phase II, single arm study of Optune® in bevacizumab-naive subjects with recurrent WHO grade III malignant glioma; D O’Connell et al; Friday, Nov. 18; abstract: #ACTR-41
Use of tumor treating fields in the first line treatment of glioblastoma; M Pandey et al; Friday, Nov. 18; abstract: #ACTR-28
Clinical experiences of tumor treating fields (TTFields) in pediatric GBM patients; J Crawford et al; Saturday, Nov. 19; abstract: #NIMG-66
Beneficial effect of tumor treating field therapy in Gliomatosis Cerebri; N Blondin; Friday, Nov. 18; abstract: #ACTR-08
Enhanced therapeutic benefits of tumor treating fields (TTFields) on superficially located glioblastoma multiforme (GBM); V Kumar et al; Friday, Nov. 18; abstract: #RTHP-30
Stability of shunt programmable valve settings with simultaneous use of the Optune transducer array; A Chan et al; Friday, Nov. 18; abstracts: #SURG-25
Treatment Delivery/Patient Education
First report of user experience, compliance outcomes, and alarm states with the second generation Optune® system; A Kinzel et al; Saturday, Nov. 18; abstract: #NIMG-50
Does personalizing tumor treating fields (TTFields) with NovoTAL in glioblastoma treatment planning make a difference? Insights from electric field simulation studies; D Garcia Carracedo et al; Saturday, Nov. 19; abstract: #NIMG-06
Compliance of tumor treating electric fields therapy and overall survival in glioblastoma; ET Wong et al; Friday, Nov. 18; abstract: #RTHP-17
Development of practice algorithms to guide treatment planning with TTFields for the management of glioblastoma; J Trusheim et al; Saturday, Nov. 19; abstract: #NIMG-23
Shared Care Model for glioblastoma patient management; J Battiste et al; Saturday, Nov. 19; abstract: #NIMG-52
Periodic transducer array shifting preserves both TTFields intensity in the gross tumor volume (GTV) and promotes scalp health during the course of glioblastoma therapy; A Naveh et al; Saturday, Nov. 19; abstract: #NIMG-26
Influence of 2 contrasting treatment planning approaches on tumor treating fields (TTFields) intensity in the gross tumor volume (GTV) and peritumoral brain zone (PBZ) in glioblastoma; D Garcia Carracedo et al; Saturday, Nov. 19; abstract: #NIMG-07
Placement of scalp electrodes (Novo TTF) does not significantly change radiation dosimetry when delivering cranial intensity modulated radiation therapy (IMRT); G Shukla et al; Friday, Nov. 18; abstract: #RTHP-34
Optimal Patient and Family Education Is Key to Improving the Efficacy of Tumor Treating Fields Plus Chemotherapy in Treatment of GBM; MG Saria et al; Saturday, Nov. 19; abstract: #NIMG-63
Tumor recurrence in areas of lower TTFields Intensity: A reverse simulation case study; J Battiste et al; Saturday, Nov. 19; abstract: #NIMG-29
Late-Breaking Oral Presentation
Prospective multi-center phase III trial of Tumor Treating Fields together with temozolomide compared to temozolomide alone in patients with newly diagnosed glioblastoma; R Stupp et al; Friday, Nov. 18
Novocure is a commercial-stage oncology company developing a novel, proprietary therapy called Tumor Treating Fields, or TTFields, for the treatment of solid tumor cancers. Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed phase 2 pilot trials investigating TTFields in non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma.
Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York City. Additionally, the company has offices in Germany, Switzerland and Japan, and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
In the United States, Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
In the United States, Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
In the United States, for the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
In the European Union, Optune is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant temozolomide, concomitant to maintenance temozolomide. The treatment is intended for adult patients, 18 years of age or older, and should be started more than four weeks after surgery and radiation therapy with adjuvant temozolomide. Treatment may be given together with maintenance temozolomide and after maintenance temozolomide is stopped.
In the European Union, Optune is also intended for the treatment of patients with recurrent GBM who have progressed after surgery, radiotherapy and temozolomide treatment for their primary disease. The treatment is intended for adult patients, 18 years of age or older, and should be started more than 4 weeks after the latest surgery, radiation therapy or chemotherapy.
Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301 in the US or by email at supportEMEA@novocure.com in the European Union.
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, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, 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, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on March 1, 2016, 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.
1 Stupp R, Taillibert S, Kanner AA, et al. Maintenance therapy with tumor-treating fields plus temozolomide vs temozolomide alone for glioblastoma: a randomized clinical trial. JAMA. 2015;314(23):2535-2543.
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