FDA Approves First Malignant Pleural Mesothelioma Therapy in Over 15 Years

The Food and Drug Administration (FDA) has approved the NovoTTF-100L System in combination with pemetrexed and platinum-based chemotherapy for the front-line treatment of patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma, marking the first treatment for this patient population in more than 15 years.

The decision is based on findings from the prospective, single-arm STELLAR trial, in which the median overall survival in patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma who received TTF plus chemotherapy was 18.2 months.

"Since 2000, we have been developing and commercializing Tumor Treating Fields (TTF) 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."

Malignant pleural mesothelioma is a rare malignancy that has been strongly linked to asbestos exposure, and an estimated 3,000 people are diagnosed with the disease in the United States annually. Prior to the NovoTTF-100L approval, pemetrexed plus cisplatin was the only FDA-approved therapy for patients with unresectable malignant pleural mesothelioma.

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 malignant pleural mesothelioma who were candidates for pemetrexed and cisplatin or carboplatin were enrolled. The primary endpoint was overall survival; secondary endpoints were overall response rate, progression-free survival and safety.

Additional results showed that the median overall survival was 21.2 months for patients with epithelioid malignant pleural mesothelioma (53 patients) and 12.1 months for those with non-epithelioid malignant pleural mesothelioma (21 patients). Sixty-two percent of patients enrolled who used NovoTTF-100L plus chemotherapy were still alive at one year. Moreover, the disease control rate in patients with at least one follow-up CT scan performed (72 patients) 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 wide effects with the combination of NovoTTF-100L and chemotherapy. The most common device-related side effect was mild-to-moderate skin irritation.

"(Malignant pleural mesothelioma) is a devastating disease, with only 10% to 20% of patients being candidates for surgery to remove the tumor," said Mary Hesdorffer, executive director of the Mesothelioma Applied Research Foundation. "Typically, mesothelioma patients who cannot have surgery receive palliative care to mitigate their symptoms. NovoTTF-100L provides unresectable (malignant pleural mesothelioma) patients with a treatment option that may improve survival. We are encouraged by the FDA approval and hope it is just the beginning of innovation in the treatment of this aggressive disease."

This article was originally published on OncLive as, "FDA Approves NovoTTF-100L Plus Chemo for Malignant Pleural Mesothelioma."