Novocure Enrolls Last Patient in INNOVATE Trial Testing Tumor Treating Fields Plus Paclitaxel in Recurrent Ovarian Cancer
Trial tests safety and potential synergy between a taxane and TTFields in the treatment of recurrent ovarian cancer
ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ: NVCR) announced today that the last patient has been enrolled in the INNOVATE trial, a phase 2 pilot trial testing Tumor Treating Fields (TTFields) therapy in combination with weekly paclitaxel for the treatment of recurrent ovarian cancer. The final data collection date will be six months after the last patient in.
“TTFields therapy is an exciting, novel treatment modality with the potential to make a difference in the lives of recurrent ovarian cancer patients,” said Professor Ignace Vergote, Chair of the Department of Obstetrics and Gynecology at the Catholic University Leuven and Director of the Leuven Cancer Institute, European Union. “We are eager to observe the results.”
The open-label trial includes 30 patients from Spain, Belgium and Switzerland. INNOVATE is designed to test the feasibility, safety and preliminary efficacy of TTFields therapy together with weekly paclitaxel in recurrent ovarian cancer patients. Novocure plans to conduct a phase 3 pivotal trial in ovarian cancer if the results from the phase 2 trial are promising.
“We were happy to pioneer this pilot project and are looking forward to working on a randomized trial testing the efficacy of TTFields in ovarian cancer,” said Professor Cristiana Sessa, Vice Head of Medical Oncology and Head of Clinical Research at the Oncology Institute of Southern Switzerland, Ospedale San Giovanni in Bellinzona.
“In all of our preclinical and clinical research over the last 15 years, we have observed a consistent physical antimitotic effect regardless of cancer type,” said Uri Weinberg, MD, PhD, Novocure’s Vice President of Research and Development, Clinical Trials. “Our preclinical research has shown synergistic effects between TTFields and taxane-based chemotherapies, and we are hopeful about the results of this study of TTFields plus weekly paclitaxel in recurrent ovarian cancer. Novocure is committed to developing TTFields as a low toxicity, effective therapy for multiple solid tumor cancers.”
About Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women in the United States. The National Cancer Institute estimated that in 2015, there were approximately 21,000 new cases of ovarian cancer diagnosed and approximately 14,000 deaths in the United States. Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old. The five-year survival rate is 44 percent, and the majority of patients present at advanced stage with 60 percent having metastatic disease. TTFields therapy is not approved for the treatment of ovarian cancer by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for ovarian cancer has not been established.
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.
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.
Media and Investor Contact:
Ashley Cordova, 212-767-7558