Progression free survival and overall survival of patients treated with Tumor Treating Fields combined with gemcitabine were more than double those of gemcitabine-treated historical controls
ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ: NVCR) will present data on Friday, Jan. 22, 2016, from its ongoing phase 2 PANOVA clinical trial at the American Society of Clinical Oncology 2016 Gastrointestinal Cancers Symposium in San Francisco showing that Tumor Treating Fields (TTFields) therapy plus first-line chemotherapy gemcitabine is tolerable and safe in patients with advanced pancreatic cancer. The data 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.
The first cohort of the prospective, single-arm study included 20 patients with advanced pancreatic cancer whose tumors could not be removed surgically and who had not received chemotherapy or radiation therapy prior to the clinical trial. The primary endpoint measured the incidence and severity of treatment-related adverse events. As a result of TTFields therapy, 10 patients experienced treatable contact dermatitis. No serious adverse events related to TTFields were reported. Fourteen patients reported serious adverse events unrelated to TTFields therapy.
A phase 3 study of the efficacy and safety of nab-paclitaxel plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer published in October 2013 in the New England Journal of Medicine1 showed that patients who received gemcitabine alone experienced a median progression free survival of 3.7 months, a median overall survival of 6.7 months, a median one-year survival of 22 percent, and a response rate of 7 percent.
In relation to these reported results for 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, a median overall survival of 14.9 months compared to 6.7 months, and a median one-year survival of 55 percent compared to 22 percent. Thirty percent of the evaluable tumors had partial responses compared to 7 percent with gemcitabine alone and another 30 percent had stable disease.
The PANOVA trial includes a second cohort testing TTFields plus gemcitabine and nab-paclitaxel in an additional 20 patients. Preclinical models have demonstrated increased cancer cell sensitivity when TTFields therapy is combined with taxane-based chemotherapies, such as nab-paclitaxel.
“The phase 2 results are promising,” said Fernando Rivera, MD, PhD, the study’s principal investigator and a Senior Medical Oncologist at the Santander University Hospital in Spain. “Given these first cohort results and the synergistic effect that was demonstrated in preclinical models when TTFields therapy was combined with taxane-based chemotherapies, I am even more optimistic about what the second cohort will show when nab-paclitaxel is added to the treatment regimen.”
“We are pleased by these results,” says Asaf Danziger, Novocure’s CEO. “Over the last 15 years, in all of our preclinical and clinical research we have observed that the physical, antimitotic effect of TTFields is consistent regardless of cancer type. Based on these data we will accelerate planning of a phase 3 clinical trial in pancreatic cancer.”
About Pancreatic Cancer
Pancreatic cancer is the fourth leading cause of cancer death in the U.S. The American Cancer Society 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 patients with metastatic pancreatic cancer is 2 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 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.
Novocure is a Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s U.S. operations are based in Portsmouth, New Hampshire, 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.
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1 Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine, The New England Journal of Medicine, October 2013, DOI: 10.1056/NEJMoa1304369
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