The Food and Drug Administration (FDA) has recently approved the NovoTTF-100L
system to be used in combination with pemetrexed (aka Alimta) plus platinum-based
chemotherapy (Cisplatin or Carboplatin) as a front-line treatment of unresectable,
locally advanced or metastatic, malignant pleural mesothelioma. This is
the first treatment for mesothelioma approved by the FDA since Alimta
was approved in 2004.
The NovoTTF-100L system is a portable, lightweight, battery operated device
intended for continuous home use by patients. It is a non-invasive, antimitotic
cancer therapy that utilizes low intensity alternating electric fields,
Tumor Treating Fields (TTFs), to interfere with the division process of cancer cells. The TTFs are
delivered to the cancerous region via transducer arrays.
Tumor Treating Fields was first approved by the FDA in 2011 for use with
glioblastoma, a type of brain cancer. Uri Weinberg, Novocure's VP
for clinical development, said the company's preclinical studies suggest
that mesothelioma cells are unusually susceptible to disruption of DNA
spindles during mitosis.
FDA approval was based on data from the
STELLAR phase II clinical trial, a single-arm trial of 80 patients who had received
no prior treatment and were not surgical candidates. Patients treated
with the NovoTTF-100L device in addition to a standard chemotherapy regimen
of pemetrexed and cisplatin or carboplatin demonstrated a median overall
survival of 18.2 months, a significant improvement over the 12.1 months
for those receiving only chemotherapy. Patients with epithelioid disease
experienced a median survival of 21.2 months. 97.2 percent of patients
experienced clinical benefit, including either a partial response or increased
There was no increase in serious systemic adverse events when NovoTTF-100L
was added to chemotherapy. Mild to moderate skin irritation was the most
common device-related side effect with NovoTTF-100L.
Studies utilizing TTFs are currently being conducted for several cancer types including ovarian,
pancreatic, gastric and non-small-cell lung cancer.
The NovoTTF-100L System is anticipated to become available for treatment
of mesothelioma patients in late 2019 or early 2020.