FDA Approves Mesothelioma Treatment After Groundbreaking Study Results

Treatment // June 24, 2019

Mesothelioma research focuses on developing new diagnostic tools that will help accurately diagnose mesothelioma cancer sooner, while also searching for a cure. There is no cure for mesothelioma, but large strides have been made in finding new treatment techniques to stop or slow disease progression and improve patient prognosis.

The last FDA-approved mesothelioma treatment emerged 15 years ago, until very recently. A study, referred to as the STELLAR study, resulted in groundbreaking findings regarding NovoTTF-100L treatment with pemetrexed and platinum-based chemotherapy. The treatment was approved by the FDA as a first-line treatment for patients with unresectable malignant pleural mesothelioma.

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STELLAR Study Goals and Results

Novocure, a company created with a goal to provide new and innovative treatment options to patients, pioneered the STELLAR study to test the effectiveness of Tumor Treating Fields (TTF) in the treatment of mesothelioma.

The STELLAR trial was used to test the effectiveness of NovoTTF-100L in treating patients with malignant pleural mesothelioma, in particular. All 80 study participants had mesothelioma that was unresectable, meaning they were not candidates for surgery. 53 patients had epithelioid mesothelioma and 21 patients had non-epithelioid cell types. Epithelioid patients demonstrated a better median overall survival of 21.2 months compared to 12.1 months for other cell types. Epithelial mesothelioma is typically less aggressive and more responsive to treatment than biphasic or sarcomatoid types.

When taking all patients into consideration, median overall survival was 18.2 months, which is about six months longer than the average survival for pleural mesothelioma patients treated with just chemotherapy. Median progression-free survival was 7.6 months. Along with improved survival, the treatment led to many patients experiencing their mesothelioma tumors shrinking or halting growth. 72 patients demonstrated a disease control rate of 97%, a partial response rate of 40%, a stable disease rate of 67% and a progressive disease rate of 3%. Compared to existing mesothelioma treatments and success rates, the STELLAR study results are groundbreaking.

NovoTTF-100L and Malignant Mesothelioma

Multimodal treatment is the most common treatment option for malignant mesothelioma patients, incorporating a mix of surgery, chemotherapy, radiation therapy or other experimental techniques. The STELLAR trial used this technique by combining Tumor Treating Fields, pemetrexed and a platinum-based chemotherapy drug, like cisplatin.

TTF is a newer technique that has been undergoing development and commercialization since 2000. It has shown success in extending survival in patients with aggressive cancers, as was demonstrated with the STELLAR study. Low-intensity alternating electrical fields are applied to a particular area (the upper torso for pleural mesothelioma patients) and are meant to disrupt cell division, therefore slowing or stopping cancer growth.

In addition to showing promise in improving survival, another benefit of TTF is that treatment is applied using a mechanical system that patients can bring home for continuous use. TTF has also shown minimal side effects. The main adverse reaction reported by patients was mild to moderate skin irritation. This doesn’t account for the treatment side effects from chemotherapy, which is done alongside TTF to kill cancer cells and prevent metastasis (spreading).

There are some limitations to who can use TTF treatment, and medical care providers must be certified before prescribing the treatment option. Patients and loved ones should discuss this option, as well as all others, with their mesothelioma specialist before determining what treatment plan is best for their individual case.

The Future of Mesothelioma Treatment

From breath tests to blood tests and now Tumor Treating Fields, mesothelioma research continues to advance with new methods for diagnosing and treating the disease. With the success shown from NovoTTF-100L, research will continue to focus on how the technology can be used to address rare cancers and how it can be used in combination with other treatment options to extend life expectancy and improve prognosis for patients.

Prior to this FDA approval, the only FDA-approved treatment for pleural mesothelioma patients unable to undergo curative surgeries was pemetrexed used in combination with cisplatin. NovoTTF-100L gives promise to patients, their loved ones and members of the mesothelioma community. Particularly, it offers hope that treatment options will expand, that they will become more widely available to mesothelioma patients at all stages and that they can contribute towards one day finding a cure.