The first new mesothelioma therapy approved by the FDA is based on a trial. In this single-arm STELLAR trial, the median overall survival rate was 18.2 months with patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma who received TTF plus chemotherapy. This combination of treatments comprises the NovoTTF-100L System along with pemetrexed and platinum-based chemotherapy for front-line treatment.
History of new mesothelioma therapy
Bill Doyle, executive chairman of Novocure, the developer of NovoTTF-100L stated, “Since 2000, we have been developing and commercializing Tumor Treating Fields (TTF) to extend survivals in some of the most aggressive forms of cancer. 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.”
What is malignant pleural mesothelioma (MPM)?
Strongly linked to asbestos exposure, MPM is a rare malignancy. Approximately 3,000 people are diagnosed with MPM each year in the US. This new therapy is welcome news as there was only one FDA-approved therapy prior to the NovoTTF-100L approval. That treatment consisted of pemetrexed plus cisplatin.
In addition to extending life, this new mesothelioma therapy approved by the FDA, is noninvasive, delivering TTF directly to the region of the tumor. No increase in serious systemic wide effects were noted with this new therapy.
Results showed patient overall survival at:
• 21.2 months for epithelioid malignant pleural mesothelioma (53 patients)
• 12.1 month for non-epithelioid malignant pleural mesothelioma (21 patients)
• 62% of those in the STELLAR study were alive at one year.
• Disease control when at least one CT scan was given as a follow-up was 97% (72 patients).
Mary Hesdorffer, NP, executive director of the Mesothelioma Applied Research Foundation, said “MPM is a devastating disease, with only 10 to 20 percent of patients being candidates for surgery to remove the tumor. 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.”