On December 12, 2016 Novocure (NASDAQ: NVCR) presented data from its phase 2 pilot PANOVA clinical trial at its research and development day suggesting that Tumor Treating Fields (TTFields) plus first-line chemotherapies nab-paclitaxel and gemcitabine may be tolerable and safe in patients with advanced pancreatic cancer (Press release, NovoCure, DEC 12, 2016, View Source [SID1234517056]). The data also suggested an improved one-year survival rate among patients who received TTFields therapy with nab-paclitaxel and gemcitabine compared to a recent phase 3 trial of patients who received nab-paclitaxel and gemcitabine alone¹. Progression free survival and one-year survival rate of patients treated with TTFields plus nab-paclitaxel and gemcitabine were more than double those of nab-paclitaxel and gemcitabine-treated historical controls¹. Novocure will submit data for presentation at an upcoming medical conference.
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The second 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. Patients reported no serious adverse events related to TTFields. Nine patients suffered from serious adverse events unrelated to TTFields therapy.
"We are extremely pleased with these results," said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "The results of the second cohort of our PANOVA trial support our preclinical work that has demonstrated increased cancer cell sensitivity when TTFields therapy is combined with taxane-based chemotherapies, such as nab-paclitaxel. We are finalizing plans and are eager to begin a phase 3 pivotal trial in advanced 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 53,000 people would be diagnosed with pancreatic cancer and about 42,000 people would die from the disease in 2016. 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.