On May 18, 2016 Novocure (NASDAQ: NVCR) reported 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) (Free ASCO Whitepaper) 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 (Press release, NovoCure, MAY 18, 2016, View Source [SID:1234512546]).

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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 (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper)’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.