Novocure (NSDQ:NVCR) said that the 1st patient has been enrolled in a Phase III pivotal trial of its tumor-treating field technology in combination with radiosurgery to treat brain metastases from non-small-cell lung cancer.
The St. Helier, N.J.-based company’s tumor treating fields (TTFields) are low-intensity, intermediate-frequency, alternating electric fields designed to disrupt cell division within cancer cells. Novocure’s commercial product, Optune, is indicated in the U.S. as a therapy in combination with temozolomide to treat gliobastoma.
Metis is the company’s 1st Phase III trial of TTFields for a cancer other than glioblastoma. The study, slated to enroll 270 patients with 1 to 10 brain mestastases, will compare patients who, following radiosurgery, receive TTFields and supportive care to those who receive only supportive care.
“We are excited to start the Metis trial and are working to diligently enroll patients,” chief science officer Dr. Eilon Kirson said in prepared remarks. “[Non-small cell lung cancer] patients with brain metastases suffer not only from their primary disease in the lungs, but also from the risk of neurocognitive deterioration due to the recurrence of brain metastases or neurotoxic treatments. We believe TTFields has the potential be an effective treatment option to prevent the appearance of new brain metastases without causing additional neurotoxicity.”
“We are happy to enroll the first patient in the Metis trial,” added Dr. Nicholas Blondin of Associated Neurologists of Southern Connecticut. “Brain metastases patients deserve more treatment options, and this trial will assess the efficacy and safety of TTFields in the treatment of brain metastases.”
Last month, Novocure touted a long-term analysis of data from a pivotal study of the Optune-temozolomide combination treatment in newly-formed glioblastomas. The company also claims positive results both in vitro and in vivo for the combination of Optune and paclitaxel in treating ovarian cancer.
Novocure won pre-market approval from the FDA for the Optune-temozolomide combination for glioblastoma in July.
