The NovoTTF-100L System has received approval from the FDA in combination with pemetrexed and platinum-based chemotherapy as a frontline treatment for patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma.
The NovoTTF-100L System has received approval from the FDA in combination with pemetrexed and platinum-based chemotherapy as a frontline treatment for patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM). This marks the first treatment to be approved for this patient population in more than 15 years.
"Since 2000, we have been developing and commercializing Tumor Treating Fields to extend survivals in some of the most aggressive forms of cancer," said Bill Doyle, executive chairman of Novocure, the developer of NovoTTF-100L. "FDA approval of NovoTTF-100L provides patients with the first FDA-approved treatment for MPM in more than 15 years and, as our first FDA-approved torso cancer indication, marks a major milestone for Novocure. We are thankful for the patients, caregivers and health care providers who partnered with us to make this possible."
The FDA granted the approval based on findings from the prospective, single-arm STELLAR trial, in which Tumor Treating Fields (TTF) plus chemotherapy demonstrated a median overall survival (OS) of 18.2 months (95% CI, 12.1-25.8) in patients with unresectable, locally advanced or metastatic MPM.
MPM is a rare malignancy that has been strongly linked to asbestos exposure, and an estimated 3000 people are diagnosed with MPM in the United States annually. Prior to the NovoTTF-100L approval, pemetrexed plus cisplatin was the only FDA-approved therapy for patients with unresectable MPM. NovoTTF-100L is a noninvasive, antimitotic cancer therapy that delivers TTF to the region of the tumor. TTF therapy uses electric fields tuned to specific frequencies that disrupt solid tumor cancer cell division. Preclinical data demonstrated that human mesothelioma cells are highly sensitive to TTF.
In the STELLAR study, 80 treatment-naïve patients with unresectable, locally advanced or metastatic MPM who were candidates for pemetrexed and cisplatin or carboplatin were enrolled. The primary endpoint was OS; secondary endpoints were overall response rate via mRECIST criteria, progression-free survival, and safety.
Additional results showed that the median OS was 21.2 months for patients with epithelioid MPM (n = 53) and 12.1 months for those with non-epithelioid MPM (n = 21). Sixty-two percent of patients enrolled who used NovoTTF-100L plus chemotherapy were still alive at 1 year. Moreover, the disease control rate in patients with at least 1 follow-up CT scan performed (n = 72) was 97%. The partial response rate was 40%, the stable disease rate was 57%, and the progressive disease rate was 3%.
Regarding safety, there was no increase in serious systemic adverse events (AEs) with the combination of NovoTTF-100L and chemotherapy. The most common device-related AE was mild-to-moderate skin irritation.