ST. HELIER, Jersey--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) announced today that the first patient has been enrolled in LUNAR, its phase 3 pivotal trial of Tumor Treating Fields at 150 kHz as a treatment for advanced non-small cell lung cancer (NSCLC) after failing platinum-based therapy. The prospective, randomized, controlled trial will test the efficacy and safety of TTFields in combination with immune checkpoint inhibitors or docetaxel – a taxane chemotherapy – two of the current standard of care treatments.
The international trial is planned to include 512 patients with stage IIIB and IV NSCLC of all histologies after failing platinum-based therapy. The primary endpoint is superior overall survival of patients treated with TTFields plus immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone. In addition, the trial will test non-inferiority in overall survival of patients treated with TTFields plus docetaxel versus immune checkpoint inhibitors alone.
“We designed this trial to test TTFields with two of the currently available standard of care treatments for advanced NSCLC following failure of platinum-based therapy, opening the trial to more patients with this disease,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “We are excited about the potential of TTFields for the treatment of advanced NSCLC, and we are pleased to start this pivotal trial.”
The LUNAR trial design was based on preclinical findings that suggest TTFields may act synergistically with certain taxanes and enhance the efficacy of immune checkpoint inhibitors. In addition, the trial design was informed by Novocure’s phase 2 pilot EF-15 trial1, which tested TTFields at 150 kHz in combination with pemetrexed chemotherapy in 42 patients with advanced second- or subsequent-line NSCLC. The EF-15 study showed that TTFields are safe and tolerable in patients with advanced NSCLC. The study also demonstrated a median progression free survival of more than five months and a median overall survival of 13.8 months. These results exceeded historical results for second-line treatment of advanced NSCLC with pemetrexed chemotherapy alone. Notably, the EF-15 trial also included patients with squamous histology (n=7, 17 percent), who typically do not respond to treatment with pemetrexed.
“The start of LUNAR, our second ongoing phase 3 trial beyond glioblastoma, further demonstrates our commitment to testing TTFields across a variety of solid tumor cancers and bringing our therapy to patients who may benefit from it,” said Novocure CEO Asaf Danziger. “We believe that treatment with TTFields is bigger than one cancer type. We are developing a profoundly different approach to cancer therapy that has the potential to improve the lives of people affected by a range of solid tumor cancers.”
For more information on the trial design, visit ClinicalTrials.gov.
About Non-Small Cell Lung Cancer
Lung cancer is the leading cause of cancer-related death in the United States. Non-small cell lung cancer (NSCLC) accounts for approximately 85 percent of all lung cancers. The incidence of NSCLC in the U.S. is approximately 185,000 new cases annually. Tumor Treating Fields (TTFields) therapy is not approved for the treatment of NSCLC by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for NSCLC has not been established.
About Novocure
Novocure is a commercial-stage oncology company developing a 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 phase 3 pivotal trials in brain metastases from NSCLC and in advanced NSCLC after failing platinum-based therapy. 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 Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.
Forward-Looking Statements
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 Pless M. et al., A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Jul 23. pii: S0169-5002(13)00308-5. doi: 10.1016
