Novocure Enrolls Last Patient in PANOVA Trial of Tumor Treating Fields Plus Chemotherapy in Advanced Pancreatic Cancer

The first cohort testing TTFields plus gemcitabine suggests improved survival and response rate compared to a historical control of gemcitabine alone

May 23, 2016 07:30 AM Eastern Daylight Time

ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ: NVCR) announced today that the last patient has been enrolled in the PANOVA trial, a phase 2 pilot trial testing Tumor Treating Fields (TTFields) plus chemotherapy in 40 patients with advanced pancreatic cancer. The final data collection date will be six months after the last patient in.

“The first cohort of the PANOVA trial demonstrated the safety and feasibility of combining TTFields with gemcitabine in pancreatic cancer,” said Dr. Marc Kueng, Senior Internist and Medical Oncologist at the Cantonal Hospital of Fribourg in Switzerland. “The combination with nab-paclitaxel has a strong scientific rationale and is compliant with the current standard of care. We are looking forward to opening a randomized-controlled study testing the efficacy of TTFields in this difficult disease.”

The prospective, single-arm study includes two cohorts of 20 patients with advanced pancreatic cancer whose tumors could not be removed surgically and who had not received prior chemotherapy or radiation therapy. Novocure presented data from the first cohort of the trial at the American Society of Clinical Oncology 2016 Gastrointestinal Cancers Symposium in January 2016.

Data from the first cohort demonstrated the safety of the combined treatment, and also suggest improved survival and response rate among patients who received TTFields therapy with gemcitabine compared to a historical control of patients who received gemcitabine alone. PANOVA patients who received TTFields therapy plus first-line gemcitabine experienced a median progression free survival of 8.3 months compared to 3.7 months for a historical control of gemcitabine alone, and a median overall survival of 14.9 months compared to 6.7 months for a historical control. Median one-year survival was 55 percent compared to 22 percent for a historical control. Of the 19 of 20 evaluable tumors, 30 percent had partial responses compared to 7 percent with gemcitabine alone and another 30 percent had stable disease. Novocure accelerated planning for a phase 3 clinical trial in pancreatic cancer after obtaining results for the first cohort of PANOVA.

The PANOVA trial was expanded in January 2015 to include a second cohort of 20 patients testing TTFields plus gemcitabine and nab-paclitaxel. Preclinical models have demonstrated increased cancer cell sensitivity when TTFields therapy is combined with taxane-based chemotherapies, such as nab-paclitaxel.

“Our preclinical research of TTFields therapy combined with taxane-based chemotherapies demonstrated a synergistic effect,” said Dr. Eilon Kirson, Chief Science Officer and Head of Research and Development at Novocure. “Given that synergy, we are optimistic about what the second cohort will show when nab-paclitaxel is added to the treatment regimen and look forward to sharing the results.”

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 or follow us at

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.

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