Novocure to Present Clinical Trial Designs and Preclinical Data on Tumor Treating Fields at the 16th World Conference on Lung Cancer

ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure, a commercial stage oncology company, announced today that its ongoing and future clinical trial designs in lung cancer will be presented at the 16^th World Conference on Lung Cancer (WCLC). The WCLC is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, organized by the International Association for the Study of Lung Cancer (IASLC). The meeting will take place in Denver, Colorado from September 6 to 9, 2015.

The data presented will include a preclinical background and the clinical trial design of the following studies testing Tumor Treating Fields (TTFields) in thoracic tumors:

• STELLAR – an ongoing phase II pilot trial of TTFields together with pemetrexed combined with cisplatin or carboplatin in malignant pleural mesothelioma;
• LUNAR – a planned phase III trial of front-line chemotherapy with TTFields for advanced squamous non-small-cell lung cancer (NSCLC); and
• METIS – a planned phase III trial of TTFields following stereotactic radiosurgery (SRS) for 1-10 brain metastases from NSCLC. The METIS trial follows the ongoing COMET phase II pilot trial for 1-5 brain metastases from NSCLC.

“The preclinical research and clinical research available to date demonstrates that TTFields’ mechanism of action affects fundamental aspects of cell division and could potentially have broad applicability across a variety of solid tumors,” said Minesh Mehta, MD, Medical Director of the Maryland Proton Treatment Center and a radiation oncologist at the University of Maryland. “I am pleased that this novel modality, associated with few side effects to date, is being explored in brain metastases with the METIS trial, as well as in primary lung cancer and mesothelioma.”

“TTFields have already been demonstrated to be safe when applied to the upper torso in a phase II pilot trial for advanced NSCLC,” said Giovanni Luca Ceresoli, MD, Head of Pulmonary Oncology at the Humanitas Gavazzeni Hospital in Bergamo, Italy. “After examining the compelling data obtained through long-term basic research of TTFields in different thoracic malignancies, we are happy to lead the research of this regional therapy in mesothelioma as a part of the STELLAR trial.”

“Novocure has developed a pipeline strategy to advance TTFields through phase II pilot and phase III pivotal clinical trials across multiple solid tumor types,” said Uri Weinberg, MD, PhD, Novocure’s Vice President for Research and Development. “In addition to ongoing trials in pancreatic cancer, ovarian cancer and brain metastases, we are committed to developing TTFields as a potential treatment modality for thoracic tumors, which unfortunately cause the highest number of cancer-related deaths worldwide.”

The following posters will be presented:

METIS: A Phase III Study of Radiosurgery with TTFields for 1-10 Brain Metastases from NSCLC
Date and Time: Tuesday, September 8 from 9:30 AM – 5:00 PM
Location: Exhibit Hall (Hall B+C)
Poster: P2.01-093
Session: Treatment of Advanced Disease – Trials in Progress

LUNAR: A Phase III Study of Front-Line Chemotherapy with TTFields for Advanced Squamous NSCLC
Date and Time: Tuesday, September 9 from 9:30 AM – 5:00 PM
Location: Exhibit Hall (Hall B+C)
Poster: P3.01-091
Session: Treatment of Advanced Disease – NSCLC

STELLAR: A Phase II Trial of TTFields with Chemotherapy for First Line Treatment of Malignant Mesothelioma
Date and Time: Tuesday, September 8 from 9:30 AM – 5:00 PM
Location: Exhibit Hall (Hall B+C)
Poster: P2.08-013
Session: Thymoma, Mesothelioma and Other Thoracic Malignancies – Mesothelioma

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.

TTFields therapy is not approved for the treatment of brain metastases and malignant mesothelioma. In the United States and Japan, TTFields therapy is not approved for the treatment of NSCLC. The safety and effectiveness of TTFields therapy in these indications has not been established.

Approved Indications

The US FDA has approved the TTFields therapy delivery system, Optune (previously known as the NovoTTF-100A System), for use as a treatment for adult patients (22 years of age or older) with histologically-confirmed GBM, following histologically or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation 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 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 supra-tentorial glioblastoma after all possible surgical and radiation therapy options have been exhausted.

About Novocure

Novocure is a private 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.