The FDA has just approved the very first therapy for malignant pleural mesothelioma (MPM) in more than 15 years. It is the NovoTTF-100L System, developed by Novocure. Not only is it the first approved therapy in more than a decade for MPM, it is also the Novocure’s very first FDA-approved therapy indicated for torso cancer.
It has been approved in combination with platinum-based and pemetrexed chemotherapy for locally advanced, unresectable, or malignant pleural mesothelioma.
Malignant Pleural Mesothelioma
MPM is a rare form of cancer which is strongly associated with exposure to asbestos. Typically, it is diagnosed in the older population, in those who were exposed to asbestos in their youth. Approximately 3,000 individuals are diagnosed each year in the US.
Sadly, only between 10 and 20% of MPM patients are eligible for surgery. Other than surgery, the only approved treatment (until now) was pemetrexed and cisplatin. The only additional option was palliative care to alleviate the effect of symptoms.
TTF stands for Tumor Treating Fields. This form of therapy has been in development for 19 years. It is being examined as a treatment for multiple aggressive cancers. NovoTTF-100L was developed by Bill Doyle.
It is a therapy which works to stop cell division (mitosis) and it is not invasive. It is delivered directly to the area of the body where the tumor is located and uses specific frequencies of electric fields to disrupt the division of cancerous cells. The researchers uncovered that, thankfully, the mesothelioma cells were very sensitive to this kind of therapy.
The research team is excited about the preclinical data of this therapy and its potential to extend survival of MPM patients.
This FDA approval was based on the STELLAR trial. The trial involved 80 locally advanced, unresectable, or metastatic malignant pleural mesothelioma patients.The investigations primary endpoint was overall survival. The trials secondary endpoints were safety, progression-free survival, and overall response rate.
The trial met its primary endpoint. For all patients in the trial the median survival was 18.2 months. For those with epithelioid MPM, the median overall survival was 21.2 months. For those with non-epithelioid MPM, the median overall survival was 12.1 months.
After one year of the therapy (taken in combination with chemotherapy), 62% of patients were still alive.
The most common AE was skin irritation from the device. There were no serious systemic effects documented from use of NovoTTF-100L.
The Mesothelioma Applied Research Foundation is extremely excited about this newly approved therapy and the hope it has brought this patient population. We have not yet reached the end goal, but this approval has brought encouragement regarding the progress of research. Scientists are beginning to uncover the innovation we need to combat this disease.
You can read more about this therapy and the clinical trial that brought about its approval here.