FDA Approves the NovoTTF-100L System in Combination With Chemotherapy for Malignant Pleural Mesothelioma
On May 23, the U.S. Food and Drug Administration (FDA) approved the NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable locally advanced or metastatic malignant pleural mesothelioma. NovoTTF-100L is a noninvasive, antimitotic cancer treatment that delivers tumor treating fields to the region of the tumor, a therapy that uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division.
Malignant pleural mesothelioma is a rare cancer that has been strongly linked to asbestos exposure. Approximately 3,000 people are diagnosed with malignant pleural mesothelioma in the United States annually. Prior to the FDA approval of NovoTTF-100L, pemetrexed plus cisplatin was the only FDA-approved therapy for patients with unresectable malignant pleural mesothelioma.
NovoTTF-100L is the first treatment for malignant pleural mesothelioma approved by the FDA in more than 15 years. Preclinical data showed that human mesothelioma cells are highly sensitive to tumor treating fields.
The STELLAR trial
The FDA approval is based on the results of the STELLAR trial. STELLAR was a prospective, single-arm trial designed to study the safety and efficacy of NovoTTF-100L plus chemotherapy first-line in patients with unresectable malignant pleural mesothelioma. The trial included 80 patients with unresectable and previously untreated malignant pleural mesothelioma who were candidates for treatment with pemetrexed and cisplatin or carboplatin. The trial was powered to prospectively determine the overall survival in patients treated with NovoTTF-100L plus chemotherapy. Secondary endpoints included overall response rate (per mRECIST criteria), progression-free survival, and safety.
The median overall survival was 18.2 months (95% confidence interval [CI] = 12.1–25.8) across all patients treated with NovoTTF-100L plus chemotherapy. The median overall survival was 21.2 months for patients with epithelioid malignant pleural mesothelioma (n = 53) and 12.1 months for patients with nonepithelioid malignant pleural mesothelioma (n = 21). More than half—62%—of patients (n = 80) enrolled in the STELLAR trial who used NovoTTF-100L plus chemotherapy were still alive at 1 year. The disease control rate in patients with at least one follow-up computed tomography scan performed (n = 72) was 97%. Forty percent of patients had a partial response, 57% had stable disease, and 3% had progressive disease. The median progression free survival was 7.6 months.
In addition, the STELLAR trial demonstrated that NovoTTF-100L could be combined with chemotherapy. 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.
NovoTTF-100L for malignant pleural mesothelioma is classified as a Humanitarian Use Device and was approved under Humanitarian Device Exemption. The HDE pathway was created to encourage companies to innovate in rare diseases with underserved patient populations.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
