NovoCure Ltd.'s electric field-based device, in combination with chemotherapy, improved survival in a phase 2 study among patients with a rare form of cancer.
Mesothelioma is a form of cancer that occurs in the thin layer of tissue that covers the majority of internal organs. There are about 3,000 new cases of mesothelioma annually in the U.S., and the median overall survival in most reported studies for this cancer is about 12 months.
NovoCure's therapy, called tumor treating fields, uses electric fields with specific frequencies to disrupt the cell division and inhibit tumor growth.
The company tested the device in a study named Stellar, along with chemotherapy drugs pemetrexed plus cisplatin or carboplatin. Pemetrexed is sold by Eli Lilly and Co. as Alimta.
Results showed that patients given the treatment survived for a median of 18.2 months since the start of therapy, a measure known as overall survival. The combination also stopped the disease from worsening for a median of 7.6 months, with about 40.3% patients registering a reduction in tumors.
A 2003 phase 3 study of patients given cisplatin plus pemetrexed had shown a median overall survival of 12.1 months, the company said in a Sept. 5 release.
Novocure already markets the device as Optune to treat glioblastoma multiforme, the most common form of primary brain cancer.
The company plans to submit an application to the U.S. Food and Drug Administration through a humanitarian device exemption pathway later in 2018. The exemption is meant for faster approval of devices for treating rare diseases, with comparatively relaxed criteria for showing efficacy.
The Saint Helier, Jersey-based company is also testing the device for treating non-small cell lung cancer, pancreatic cancer and ovarian cancer.