Novocure Announces Presentation of Subgroup Analysis of PANOVA Data Showing Overall Survival Benefit of Tumor Treating Fields Plus Gemcitabine in Advanced Pancreatic Cancer Patients

Median overall survival exceeded 15 months in patients with locally advanced pancreatic cancer treated with TTFields therapy combined with gemcitabine

ST. HELIER, Jersey–()–Novocure (NASDAQ: NVCR) announced today that a new subgroup analysis of its ongoing phase 2 pilot PANOVA clinical trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 3-7, 2016, demonstrating an overall survival benefit in advanced pancreatic cancer patients treated with Tumor Treating Fields (TTFields) combined with gemcitabine compared to historical controls of gemcitabine alone.

Results were obtained from the first of two 20-patient cohorts. Of the 20 patients in the first cohort of the trial, 13 had distant metastases and seven had locally advanced unresectable disease. Locally advanced pancreatic cancer is a tumor that has not yet spread to distant organs, yet it cannot be removed entirely by surgery because it has grown into nearby major blood vessels. Roughly 30 percent of pancreatic cancer patients are diagnosed with locally advanced unresectable disease, and roughly 50 percent of pancreatic cancer patients are diagnosed with metastatic disease.

PANOVA patients experienced a median progression free survival (PFS) of 8.3 months (95% Cl 4.3, 10.3), with locally advanced patients reaching a median PFS of 10.3 months (95% Cl 2.8, NA) and patients with metastatic disease reaching a median PFS of 5.7 months (95% CI 3.8 -10.3). PFS rate at six months was 56 percent. Of the 19 out of 20 evaluable tumors, 30 percent had partial response and another 30 percent had stable disease.

The median overall survival (OS) for all patients was 14.9 months. Median OS was longer than 15 months in locally advanced patients with 86% of patients alive at end of follow up. Patients with metastatic disease experienced a median OS of 8.3 months (95% Cl 4.3-14.9). The one-year survival rate was 55 percent – 86 percent in locally advanced and 40 percent in metastatic disease.

“The results of this subgroup analysis are very telling, demonstrating that pancreatic cancer patients who are treated with TTFields therapy plus gemcitabine before their cancer metastasizes could have a greater chance of survival,” said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure. “We believe TTFields therapy plus gemcitabine could dramatically improve survival in advanced pancreatic cancer patients.”

Novocure presented data from the first cohort of PANOVA at ASCO GI in January 2016, suggesting an increase in PFS and OS for patients receiving TTFields in combination with gemcitabine compared to historical controls of gemcitabine alone. Novocure will complete enrollment for the second cohort of PANOVA this year. After obtaining data from the first cohort of PANOVA, Novocure accelerated planning for a phase 3 pivotal trial in pancreatic cancer.

“Pancreatic cancer is one of the most lethal cancers, and it is most often diagnosed at advanced stages, when surgery is not a curative option,” said Asaf Danziger, CEO of Novocure. “Our early data in this cancer type suggest TTFields therapy could make a meaningful difference in the lives of patients with this devastating disease.”

Novocure will also have two e-publications featured at ASCO’s Annual Meeting:

  • The antitumor activity of alternating electric fields (TTFields) in combination with immune checkpoint inhibitors
  • Development of practice algorithms to guide treatment planning with TTFields for the management of glioblastoma (GBM)

During the conference, Novocure representatives will be at booth #6109.

About Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer death in the U.S. The National Cancer Institute estimated that about 48,960 people would be diagnosed with pancreatic cancer and about 40,560 people would die from the disease in 2015. Five-year survival among pancreatic cancer patients is less than 6 percent.

Tumor Treating Fields (TTFields) therapy is not approved for the treatment of pancreatic cancer by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for pancreatic cancer has not been established.

About Novocure

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.

Approved Indications

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.

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.

Contacts

Media and Investor Contact:
Novocure
Ashley Cordova, 212-767-7558
acordova@novocure.com

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