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 visitwww.novocure.com or follow us at www.twitter.com/novocure.
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 Quarterly Report on Form 10-Q filed on Oct. 27, 2015, 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.
1 Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine, The New England Journal of Medicine, October 2013, DOI: 10.1056/NEJMoa1304369