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
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
DXC Technology Named a 2018 Thomson Reuters Top 100 Global Technology Leader18.1.2018 23:12 | Pressemelding
DXC Technology (NYSE: DXC) has been recognized as a 2018 Top 100 Global Technology Leader by Thomson Reuters. The inaugural program identifies the tech industry’s most operationally sound and financially successful organizations. The Thomson Reuters Top 100 Global Tech Leaders study, the industry’s first holistic assessment of today’s leading tech companies, utilizes a 28-point data-driven algorithm to objectively identify organizations positioned to thrive in a complex and changing business environment. The patent pending methodology, developed by the Thomson Reuters Boston Innovation Lab, is based on eight principal pillars of performance: Financial Performance, Management and Investor Confidence, Risk and Resilience, Legal Compliance, Innovation, People and Social Responsibility, Environmental Impact, and Reputation. According to Thomson Reuters, these are the companies whose final scores across the pillars outshine over 5,000 other technology companies around the world. “DXC Techno
IFF Honors Dominique Ropion with Prestigious Master Perfumer Title18.1.2018 21:15 | Pressemelding
Regulatory News: This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180118006275/en/ Dominique Ropion (Photo: Business Wire) International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF), a leading innovator of sensory experiences that move the world, has named Dominique Ropion Master Perfumer. The Company’s designation recognizes perfumers who have demonstrated consistent and outstanding levels of creativity and craftsmanship in the art of perfumery, and exceptional leadership in and measurable impact on the industry. Mr. Ropion is the second perfumer at IFF recognized with the prestigious title, which was established in 2013. “At the heart of IFF are the people who consistently go above and beyond to passionately pursue their art and by doing so, revolutionize the industry,” said IFF Chairman & CEO Andreas Fibig. “In his 17 years with us, Dominique has consistently achieved this outstanding level of creativity and p
The Securities & Exchange Commission Announces Several Judgments And Injunctions Entered Against Defendants In The SEC v. Benger, et al. Litigation18.1.2018 19:21 | Pressemelding
The following statement is being issued by the Securities & Exchange Commission regarding Benger Fair Fund Class Action: Legal Notice BENGER FAIR FUND NOTICE The United States Securities and Exchange Commission authorized this Notice. This is not a solicitation from a lawyer. If you purchased or otherwise acquired China Voice Holding Corp., Biomoda, Inc., Pharma Holdings Inc., World Energy Solutions, Inc., Revolutions Medical Corp., Earthsearch Communications, Inc., and Essential Innovations Technology Corp. common shares from Defendants outside of the United States between March 1, 2007 and February 28, 2009, inclusive (the “Relevant Period”), you may be entitled to receive a monetary payment from the Benger Fair Fund (“Fair Fund”). Background In the action titled Securities and Exchange Commission v. Benger, et al. pending in the United States District Court for the Northern District of Illinois, Case No. 09-CV-676, several judgments and injunctions were entered against defendants Ha
Pharnext’s Pivotal Phase 3 Trial PLEO-CMT to Be Featured at the 22nd Edition of the Francophone Peripheral Nerve Society Conference18.1.2018 16:45 | Pressemelding
Regulatory News: Pharnext SA (Paris:ALPHA) (FR0011191287 - ALPHA), a biopharmaceutical company pioneering a new approach to the development of innovative drugs based on the combination and repositioning of known drugs, today announced the Company will present an update from its ongoing pivotal Phase 3 clinical trial PLEO-CMT evaluating PXT3003 for the treatment of Charcot-Marie-Tooth type 1A disease (CMT1A), in an oral session during the 22nd edition of the Francophone Peripheral Nerve Society conference. The gathering will take place on January 26-27, 2018 in Paris (France). Details of the presentation are as follows: Date Time Session Friday January 26, 2018 From 3:03 to 3:15pm CET Selected Oral Communications Session Title: Status of the Pivotal Phase III Study (PLEO-CMT) Assessing the Efficacy and Safety of PXT3003 in the Treatment of Adult Patients with Charcot-Marie-Tooth type 1A Speaker : Prof. Shahram Attarian (Marseille) For more information about the event please visit : www.
ExaGrid Selected as Finalist for Storage Magazine’s 2017 “Product of the Year – Backup and DR Hardware” Award18.1.2018 16:45 | Pressemelding
ExaGrid®, a leading provider of hyper-converged secondary storage for backup, today announced that its EX Series of backup storage appliances with data deduplication has once again been selected as a finalist for TechTarget’s Storage magazine/SearchStorage.com 2017 “Product of the Year” award in the “Backup and DR Hardware” category. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180118006039/en/ These annual awards, now in their 16th year, showcase the year’s latest and greatest innovations in technology. “These premier awards are of particular import as the panel of judges are genuine experts in an increasingly complex segment of data center technology,” said Bill Andrews, CEO and President of ExaGrid. “To have been selected given their stringent criteria is an honour of which we’re quite proud.” Only ExaGrid uses a scale-out architecture with a unique loading zone, which addresses all of the scalability and performance cha
Piraeus Bank Completes the Sale of a Portfolio of €0.2bn of Romanian Originated Loans to Kruk Group18.1.2018 16:22 | Pressemelding
Piraeus Bank SA, in conjunction with Piraeus Bank Romania (together “the Bank”), have completed the sale of a portfolio of €0.2bn of Romanian originated loans to Kruk Group. The sale, together with sales of Romanian loans of €0.4bn in previous periods, have been part of the Bank’s focused and systematic actions, targeted to fulfill its restructuring plan obligations, NPE operational targets and de-risk its balance sheet. View source version on businesswire.com: http://www.businesswire.com/news/home/20180118006013/en/ Contact information Media enquiries: Piraeus Bank Group George Papaioannou, Head of Press Office +30 210 3288 830 or Powerscourt Alex Rowbottom +44 (0)20 7250 1446
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom