FDA Approves New Mesothelioma Treatment for the First Time in 15 Years

New FDA approved treatment for mesothelioma

Malignant mesothelioma is an aggressive disease that is most often diagnosed in the later stages, at stage 3 or stage 4. Late-stage mesothelioma diagnoses limit treatment options for the patient, typically eliminating the possibility of radical surgeries. Multimodal therapy is the most common treatment for mesothelioma cancer, consisting of a combination of surgery, chemotherapy, and/or radiation. The possibility of multimodal therapy or what combination is used depends on a case-by-case basis.

While there is no cure for mesothelioma, researchers have continued to develop new diagnostic techniques and treatment options, seeking to improve survival for patients. It has been 15 years since the FDA has approved a treatment for pleural mesothelioma, until recently after results were released regarding a treatment referred to as NovoTTF-100L. The FDA-approved treatment combines the NovoTTF-100L System with pemetrexed and platinum-based chemotherapy as a first-line treatment for patients with locally advanced or metastatic malignant pleural mesothelioma.

What Is NovoTTF-100L?

NovoTTF-100L is a treatment that utilizes a technology known as Tumor Treating Fields (TTF). Tumor Treating Fields are non-invasive and use low-intensity alternating electrical fields to disrupt cell division by destabilizing the proteins responsible for cell division. When the proteins cannot work properly, the mesothelioma cells cannot divide, stopping or slowing cancer growth.

This technique is relatively new and is still being heavily tested for the treatment of various cancers, but could be a popular option for late-stage cancer patients that are unable to undergo invasive surgical procedures. In the case of malignant pleural mesothelioma, TTF is applied to the upper torso using TTF equipment that is designed for continuous at-home use. There are currently no additional safety risks that have surfaced when using TTF in combination with chemotherapy, other than mild or moderate skin irritation as a device-related side effect.

Treatment Promise from STELLAR Study Results

NovoTTF-100L was researched in a study referred to as the STELLAR study, focusing on 80 patients, all with unresectable pleural mesothelioma. The patients received Tumor Treating Fields treatment and chemotherapy to deliver results that were then compared to data on mesothelioma patients treated only with chemotherapy.

The study showed that patients treated with the new combination therapy saw a median overall survival of 18.2 months. This is a more than six-month improvement compared to those treated only with chemotherapy that typically see an average survival of one year. 53 patients in the study had epithelioid malignant mesothelioma (a less aggressive cell type than biphasic or malignant sarcomatoid mesothelioma) with a median overall survival of 21.2 months. 21 patients of non-epithelioid cell types had median overall survival of 12.1 months. One year after enrollment in the study, 62% of the patients were still alive.

The STELLAR study primarily focused on improving survival, but also targeted overall response rate and disease progression. A follow-up CT scan was performed after receiving the NovoTTF-100L treatment, and 72 patients demonstrated a 97% disease control rate. Partial response rate was 40%, stable disease rate was 67%, and progressive disease rate was 3%.

The Future of NovoTTF-100L for Treating Pleural Mesothelioma

Ideally, researchers would like to find a cure for mesothelioma. Although the NovoTTF-100L System, pemetrexed and platinum-based chemotherapy combination cannot be seen as a cure, the new treatment technique is a huge advancement in mesothelioma research.

If patients have mesothelioma cancer that has spread, or metastasized, their treatment plan typically focuses on palliative treatments. Palliative treatments do not aim to kill or remove the cancer, but rather to lessen patient symptoms to improve quality of life. NovoTTF-100L gives late-stage patients the ability to deviate away from only palliative options and to potentially improve their life expectancy. Mary Hesdorffer, Executive Director of the Mesothelioma Applied Research Foundation has spoken out about the FDA approval, noting the potential of NovoTTF-100L and how it could be an innovation in the treatment of the aggressive cancer.