UPDATE: As of May 2019, the device Optune Lua, formerly known as NovoTTF-100L, was approved by the FDA under the Humanitarian Device Exemption (HDE) in combination with chemotherapy.
If you’re not sure what the title of this article means, you are probably not alone. A brand new concept in mesothelioma treatment has just completed a Phase 2 trial in combination with chemotherapy, and its promising results were just made public today.
According to Novocure, the pharmaceutical company b
ehind this study, Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. The therapy is administered through a device worn by the patient.
The trial, named STELLAR, consisted of a combination of standard chemotherapy (Alimta/cisplatin or carboplatin) with Tumor Treating Fields.
This Phase 2, single arm study, of 80 patients reported a median overall survival of 18.2 compared to 12.1 months seen in the original Alimta/cisplatin only trial.
The company’s press release noted that Novocure received a Humanitarian Use Device (HUD) designation for the use of Tumor Treating Fields for the treatment of malignant pleural mesothelioma in 2017 and plans to submit a Humanitarian Device Exemption (HDE) application to the U.S. Food and Drug Administration (FDA) for approval later this year.
“It is exciting to see innovations that can be synergistic with chemotherapy without additive toxicity,” said Mary Hesdorffer, expert mesothelioma nurse practitioner and executive director of the Mesothelioma Applied Research Foundation.
