Long-term Analysis of All 695 Patients Enrolled in Novocure’s Phase 3 Pivotal Trial in Newly Diagnosed Glioblastoma Confirms Superior Progression Free and Overall Survival Seen in the Trial’s Interim Analysis
Data demonstrate superior two, three and four year survival of patients treated with Optune™ together with temozolomide
ST. HELIER, JERSEY–(BUSINESS WIRE)–Novocure (NASDAQ:NVCR) announced today that long-term survival analysis of the full 695 patient dataset from the phase 3 pivotal EF-14 trial of Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) will be presented as a late-breaking oral presentation at the 21st Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) in Scottsdale, Arizona, on Friday, Nov. 18, 2016.
The long-term survival analysis of the full and mature dataset 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 mature analysis was consistent with the interim analysis of the EF-14 trial.
“The analysis of the mature dataset provides an impressive confirmation of the improvement in both progression free and overall survival we saw in the trial’s interim analysis results, and demonstrates the trial met its prespecified endpoints at both interim and long-term analyses,” said 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. “I look forward to sharing the data with the scientific community in November.”
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. 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.
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
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.
Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301.
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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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