Journal of the American Medical Association (JAMA) Publishes Pivotal Phase 3 Data for Optune Plus Temozolomide to Treat Newly Diagnosed Glioblastoma
Novocure (NASDAQ: NVCR) announced today that data from the pivotal phase 3 clinical trial of Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) have been published in the Journal of the American Medical Association (JAMA). The EF-14 trial results show that Optune plus standard of care temozolomide significantly extended both progression-free survival (PFS) and overall survival (OS) compared with temozolomide alone in the treatment of adults with newly diagnosed GBM. Optune is a portable, non-invasive device that delivers low-intensity, intermediate frequency, alternating electric fields – referred to as Tumor Treating Fields, or TTFields – that inhibit cancer cell replication and cause cancer cell death.
“The EF-14 data are spectacular,” said Roger Stupp, MD, Director of the Department of Oncology and University Hospital Cancer Center at the University of Zurich, Switzerland, and EF-14 Principal Investigator. “They support Tumor Treating Fields as a new standard of care for patients suffering from glioblastoma. These results establish a proof-of-principle of an entirely new cancer treatment modality.”
The U.S. Food and Drug Administration (FDA) approved Optune for the treatment of adults with newly diagnosed GBM in combination with temozolomide on Oct. 5, 2015, based on the EF-14 phase 3 trial results. Optune is the first FDA-approved therapy in more than a decade to demonstrate statistically and clinically significant extension of survival in newly diagnosed GBM patients. The FDA previously approved Optune in April 2011 for the treatment of adults with GBM following tumor recurrence after receiving chemotherapy.
Superiority versus Standard Treatment Halts Trial Early
EF-14 is a large, multinational, open-label, randomized phase 3 trial comparing Optune in combination with temozolomide to temozolomide alone in 700 patients with newly diagnosed GBM. The trial was designed to test both PFS and OS.
In November 2014, the trial’s independent data monitoring committee concluded that the study met its endpoints at its pre-specified interim analysis of the first 315 patients with 18 months or more of follow-up. The committee recommended that the trial be terminated early for success and that all control patients be offered TTFields therapy even prior to progression.
The EF-14 interim analysis reported in JAMA demonstrates that, after a median follow-up of 38 months:
- In the intent-to-treat population, patients treated with TTFields plus temozolomide showed a statistically significant increase in PFS, the primary endpoint, compared to temozolomide alone (median PFS 7.1 months versus 4.0 months, hazard ratio=0.62, p=0.0013).
- In the per-protocol population, patients treated with TTFields plus temozolomide demonstrated a statistically significant increase in OS, a powered secondary endpoint, compared to temozolomide alone (median OS 20.5 months versus 15.6 months, hazard ratio=0.64, p=0.0042). In the intent-to-treat population, the median OS was 19.6 months versus 16.6 months, respectively, hazard ratio=0.74 (p=0.0329).
- The two-year survival rate was 50 percent greater with TTFields plus temozolomide versus temozolomide alone: 43 percent versus 29 percent.
In addition, the trial showed Optune could be safely combined with temozolomide. There was no significant increase in systemic toxicities from Optune in combination with temozolomide versus temozolomide alone. The most common adverse reaction from Optune treatment was mild to moderate skin irritation, which was easily managed, reversible and did not result in treatment discontinuation.
Read the full article published in the latest issue of JAMA.
“We are pleased the EF-14 trial results have been published in JAMA, one of the most highly recognized and respected peer-reviewed medical journals,” said Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “We believe the data will give physicians even greater confidence in the value and importance of Optune as an effective and safe treatment option for newly diagnosed GBM patients. We believe EF-14 is the first trial in glioblastoma to be stopped at the interim analysis because of clear superiority. The findings inspire us at Novocure to continue our robust research program investigating TTFields therapy in more than a dozen other solid tumor types.”
GBM is the most common and aggressive form of primary brain cancer. Approximately 12,500 people are diagnosed with GBM or tumors that typically progress to GBM in the United States each year. Median overall survival in newly diagnosed patients is approximately 15 months with existing standard therapies.
About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
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 4 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.
In Japan, Optune (the NovoTTF-100A System) is approved for the treatment of adult patients with recurrent supratentorial glioblastoma after all possible surgical and radiation therapy options have been exhausted.
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.
Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s US operations are based in Portsmouth, NH and New York, NY. 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 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 Quarterly Report on Form 10-Q filed on October 27, 2015 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.
Media and Investor Contact:
Ashley Cordova, 212-767-7558
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
NBC Universal, Havas Group and Endemol Shine Discuss a Future with AI, Blockchain and VR at IBC201825.5.2018 18:20 | Pressemelding
As is fitting for the home of technical invention and innovation, IBC2018 will present a broad range of ambitious and timely elements to engage, inform and inspire content creators and owners from around the world that will visit the RAI, Amsterdam from 13-18 September 2018. The must-attend event includes fresh inspiring conference themes that will focus on innovative new platforms, audience engagement and interaction/immersion, as well as a wide-ranging exhibition that will encompass all the latest technologies from AI and VR to advanced cloud-based workflows. Registration for IBC2018 is now open at: https://ibc.itnint.com/IBC18/Online/RegLogin.aspx “The media landscape is evolving at an unprecedented rate, with new platforms, technologies and even new realities at our disposal that offer greater opportunities for content innovation and audience engagement,” said Michael Crimp, CEO, IBC. “IBC is preparing an outstanding programme of conference sessions, forums and exhibition features
Pavilion of France at the 16th International Architecture Exhibition – La Biennale di Venezia25.5.2018 09:26 | Pressemelding
The concept for Infinite Places , developed by the Encore Heureux team, led by the architects Nicola Delon, Julien Choppin, and Sébastien Eymard, presents places produced by new and inventive processes that generate architectural processes of value. This exhibition project, which considers the territory as a whole, highlights initiatives on the part of civil society and communities that embody a certain free spirit of experimentation and the possibilities opened up by architecture. These projects are expressions of programmatic freedom and generosity, and they live up to the theme of Freespace adopted by the two commissioners of the 16th International Architecture Exhibition – La Biennale di Venezia, the Irish architects Yvonne Farrell and Shelly McNamara. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180525005191/en/ French Pavilion Venice Architectural Biennale, copyright S. Scher Statement of the curators « Through the I
SIA Acquires Card Processing Businesses in Central and Southeastern Europe from First Data25.5.2018 08:30 | Pressemelding
SIA, a European high-tech leader in payment infrastructure and services, and First Data Corporation (NYSE: FDC), a global leader in commerce-enabling technology, have signed an agreement for SIA to acquire First Data’s card processing businesses in parts of Central and Southeastern Europe for €375 million. In 2017, these businesses generated a combined revenue of approximately €100 million for First Data. This acquisition by SIA provides card processing, card production, call center and back-office services, including 13.3 million payment cards, 1.4 billion transactions, in addition to the management of POS terminals and ATMs. These businesses are primarily located in 7 countries: Greece, Croatia, Czech Republic, Hungary, Romania, Serbia and Slovakia. As a result of the transaction, SIA will become a leading player in processing and services in the region. The agreement includes the transfer of about 1,400 First Data employees into SIA. “This acquisition is in line with our strategy to
Westinghouse Accident Tolerant Fuel Development Moves Forward with Cooperation Agreement with ENUSA25.5.2018 06:00 | Pressemelding
Westinghouse Electric Company today announced that it will collaborate in the development of its EnCore® Fuel, the revolutionary accident-tolerant fuel (ATF) design, with ENUSA Industrias Avanzadas (ENUSA) through a Frame Cooperation Agreement (FCA). “This agreement serves to strengthen the technical and commercial relations between ENUSA and Westinghouse as we work to develop leading nuclear fuel technology,” said Torbjörn Norén, European Fuel Group and EMEA Fuel Delivery Director at Westinghouse. “Westinghouse’s work with ENUSA in the Spanish and European Fuel Group markets will help to facilitate agreements with customers to launch EnCore Fuel demonstration programs in their plants.” Under the terms of the agreement, the newly signed FCA establishes the framework that will regulate the different Joint Development Programs (JDPs) to be launched between both companies. The first JDP will evaluate the application of the segmented rod concept and develop models of ATF / EnCore fuel beha
BRIC HOLDING Offers Aimedis – ICO: Germany’s Leading eHealth Platform Goes Public25.5.2018 06:00 | Pressemelding
Since Wednesday, May 16, investors finally have a chance to claim their share of a unique success story, the international market roll-out of Aimedis, by purchasing AIM tokens: AIM tokens are now available with a 20% presale bonus PLUS a 5% early bird-premium only at the Czech investment house BRIC INVEST https://www.bric-holding.com/home_en.html! Aimedis aims to shape the future of healthcare by providing an advanced and fully operational platform, secured by blockchain and supported by AI, that enables patients to take control, secure the exchange of their medical data, access the best healthcare providers, get advice, prescriptions, personal health upgrades and to become part of the health revolution. And we are not talking about the future: The revolutionary Aimedis platform is already deployed as a live working system and is already in use in major hospital groups in Germany! By issuing 300 million AIM tokens at a nominal value of 0,12 USD each, the Aimedis consortium will raise c
Alps Electric to Acquire Greina Technologies, Inc. as Part of Sensor Business Strengthening25.5.2018 02:33 | Pressemelding
Alps Electric Co., Ltd. (TOKYO: 6770; President: Toshihiro Kuriyama; Head Office: Tokyo) today announces that on May 14, 2018 the company signed a share purchase agreement with Greina Technologies, Inc. (Salt Lake City, Utah, U.S.A.; President/CTO: Daniel J. Lee) whereby Alps Electric will acquire Greina Technologies, making it a wholly owned subsidiary. Alps Electric signed a share purchase agreement with Greina Technologies on May 14, 2018. Through the agreement, Alps Electric aims to add even greater value to its sensing solutions for the automotive market, as well as the consumer electronics and mobile market, by combining high-accuracy positioning technology based on original algorithms developed by Greina Technologies with Alps Electric’s compact, high-performance wireless communication module technology. An engineering firm specializing in positioning systems, Greina Technologies was established in Salt Lake City, Utah, in September 2012. Engaging in such activities as design an