Tumor Treating Fields Win FDA Approval for Mesothelioma Treatment

The FDA has approved an electricity-based mesothelioma treatment known as Tumor Treating Fields (NovoTTF-100L). The treatment is approved for use along with standard mesothelioma chemotherapy. It is the first new treatment for pleural mesothelioma since the approval of Alimta (pemetrexed) in 2004.

Approval of NovoTTF-100L was based on the promising results of the STELLAR phase 2 mesothelioma clinical trial. Those results, released in April, were even better than expected.

Electricity is the Basis of Tumor Treating Fields

The Tumor Treating Fields approach was created by Jersey-based Novocure. It first found success in the treatment of the deadly brain cancer glioblastoma.

The technology uses electrical fields to destabilize critical proteins responsible for cell division.

When these proteins cannot do their job, mesothelioma cells cannot divide. Preclinical data showed that mesothelioma cells are especially sensitive to Tumor Treating Fields.

Combination Treatment Extends Mesothelioma Survival

The STELLAR study included 80 patients with unresectable pleural mesothelioma. They received Tumor Treating Fields along with standard chemotherapy. Researchers compared their results with data on mesothelioma patients who received only chemotherapy.

Patients who had the combination treatment had a median overall survival of more than a year-and-a-half. That is six months longer than mesothelioma patients treated with chemotherapy alone. For patients with epithelial mesothelioma, overall survival was 21.2 months.

A full 97 percent of NovoTTF-100L patients achieved some level of disease control. It took a median of 7.6 months for their mesothelioma tumors to start growing again, compared to just 5.7 months for the chemotherapy-only group.

The technology did not appear to cause any serious side effects. Based on these findings, the FDA granted the NovoTTF-100L technology Humanitarian Use Designation in 2017.

“Since 2000, we have been developing and commercializing Tumor Treating Fields to extend survivals in some of the most aggressive forms of cancer,” says Bill Doyle, executive chairman of Novocure. “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.”

Tumor Treating Fields a New Standard of Care?

Pleural mesothelioma is resistant to conventional cancer treatments. Even though most mesothelioma patients receive chemotherapy, many of them do not get much benefit from it.

Tumor Treating Fields could change that. STELLAR trial investigator Oncologist Giovanni Luca Ceresoli, MD, sees great promise in the technology.

“I believe Tumor Treating Fields represent an extremely promising therapeutic option that, if approved, should be added to standard of care chemotherapy for the treatment of malignant pleural mesothelioma,” he said in a news release last year.

Mesothelioma patients with implanted devices like pacemakers or defibrillators are not candidates for this treatment. Only providers who are trained and certified by Novocure can offer it.

Source:

“FDA Approves the NovoTTF-100L™ System in Combination with Chemotherapy for the Treatment of Malignant Pleural Mesothelioma”, May 23, 2019, News Release, Novocure Website, https://www.novocure.com/fda-approves-the-novottf-100ltm-system-in-combination-with-chemotherapy-for-the-treatment-of-malignant-pleural-mesothelioma/