The FDA has approved the NovoTTF-100L System in combination with pemetrexed and platinum-based chemotherapy for the frontline treatment of patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM), 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 (OS) in patients with unresectable, locally advanced or metastatic MPM who received TTF plus chemotherapy was 18.2 months (95% CI, 12.1-25.8).
"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."
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 Tumor Treating Fields (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.
"MPM is a devastating disease, with only 10 to 20 percent of patients being candidates for surgery to remove the tumor," said Mary Hesdorffer, NP, 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 MPM 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."
FDA Approves the NovoTTF-100LTM System in Combination with Chemotherapy for the Treatment of Malignant Pleural Mesothelioma. Novocure. Published May 23, 2019. https://www.novocure.com/fda-approves-the-novottf-100ltm-system-in-combination-with-chemotherapy-for-the-treatment-of-malignant-pleural-mesothelioma. Accessed May 23, 2019.