Novocure Ltd. is hoping to apply its Tumor Treating Fields (TTFields) therapy to both ovarian cancer and pancreatic cancer. During the St. Helier, Jersey Isle-based firm's research and development day, it revealed top line results from two studies that showed the effectiveness of TTFields to treat these cancer patient populations.

TTFields are low-intensity alternating electric fields used to halt tumor growth. Novocure said the shape and special characteristics of rapidly dividing tumor cells make them susceptible to damage when exposed to TTFields. The company said the delivery of these fields is through a portable home use medical device. Patients will wear patches of transducer arrays that are placed on their skin on the part of the body that is being treated.

Novocure has had approval to use TTFields in its Optune therapy, for the treatment of glioblastoma patients, since 2011. Earlier this year, the company received FDA approval for the green light for the second generation of Optune. (See Medical Device Daily, July 18, 2016.)

Novocure's Chief Science Officer, Eilon Kirson said the company was fairly pleased with the INNOVATE (ovarian cancer) and PANOVA (pancreatic cancer) top-line data that was just released.

"These results are encouraging enough that we have a fairly strong efficacy and safety signal to justify larger scale testing to gain approval for ovarian cancer," Kirson, told Medical Device Daily.

Results from INNOVATE, showed that TTFields plus paclitaxel yielded median progression-free survival of 8.9 months versus 3.9 months of paclitaxel-alone historical control. Median overall survival has not been reached yet in INNOVATE compared to 13.2 months for paclitaxel-alone, while one-year survival rate was 61 percent in the trial. About half of the patients experienced mild to moderate skin irritation while two reported severe skin irritation due to Optune and had to take a break from treatment. There were about 30 patients in the study.

The company also disclosed positive data from the second cohort of its Phase 2 PANOVA study in pancreatic cancer, which showed that Optune plus gemcitabine and paclitaxel improved survival rates. The data was numerically better than that from the first cohort of the study (Optune plus gemcitabine). Specifically, the second cohort showed median progression-free survival of 12.7 months while the median overall survival had not been reached yet, compared to 8.3 months and 14.9 months from the first cohort. About 20 patients were in the pancreatic cancer study.

"I think the results are extremely exciting," Kirson, said of PANOVA. "There is such a high unmet need in pancreatic cancer treatment. There are so few effective therapies for these patients. If we can do something to help modify the disease course for patients, that would be amazing."

A phase 3 study design for the pancreatic cancer treatment is in the final stages with first patient enrollment expected in the second half of 2017.

Larry Biegelsen, an analyst with Wells Fargo, said the data could help push future adoption rates of Optune.

"We expect this growing body of clinical data supporting the safety and efficacy of Optune in various tumors to create a halo effect around TTFields for the currently approved glioblastoma indication," he said.

Biegelsen said that assuming two years for patient enrollment and 18-month follow-up, final data from PANOVA could come in 2021 or 2022 with FDA approval for the pancreatic cancer indication possibly occurring in 2022 or 2023.

Novocure is also evaluating radiosurgery alone or with TTFields in brain metastases from non-small cell lung cancer through its METIS study. The company is in the enrollment phase for the 270-patient study. METIS is the company's first pivotal trial outside of glioblastoma.

PUSHING FORWARD

Since the company first received the nod for Optune it has seen significant growth. In its 3Q16 earnings call, the company said revenues increased to $21.7 million, compared to $9 million for the same period in 2015. Global revenues included revenues outside of the U.S. of more than $3.5 million in 3Q16 versus $0.4 million in 3Q15.

Novocure might have the market cornered on using TTFields therapy to treat tumors. Kirson noted that the company had secured patents for the therapy. When asked about possible competition, Kirson said that cancer was a disease where there wasn't a one-size-fits-all solution and that all therapies were welcome.

"I think of all therapies for oncology patients as tools that we need to use to treat cancer," Kirson said. "We need as many as many tools as possible. The more tools the better. I don't think anyone has invented the magic bullet that makes cancer go away completely and until that day comes it's going to be a battle."