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New Tumor-Fighting Tool to Receive Accelerated FDA Approval for Treating Mesothelioma

The success of a clinical trial evaluating the effectiveness of the new treatment known as Tumor-Treating Fields (TTFields) has led to possible accelerated FDA approval for the treatment of mesothelioma. Novocure, the company that manufactures TTFields, expects to receive a Humanitarian Device Exception (HDE), which could make the treatment available to mesothelioma patients as early as 2019.

According to the American Association for Cancer Research (AACR), TTFields is a noninvasive anticancer treatment modality that “utilizes alternating electric fields at specific frequencies and intensities to selectively disrupt mitosis in cancerous cells.” TTFields “target proteins crucial to the cell cycle, leading to mitotic arrest and apoptosis” and it “facilitates an antitumor immune response.”

Clinical trials of TTFields have proven safe and effective in patients with glioblastoma multiforme (GBM)—an aggressive cancer that begins in the brain, and is FDA approved for use in newly diagnosed and recurrent GBM. Trials in other localized solid tumors are ongoing.

The clinical trial, an ongoing multicenter phase II study conducted by a team of researchers in Europe, has shown that TTFields as a first-line treatment improves the effectiveness of standard chemotherapy for mesothelioma patients. The treatment works with chemotherapy to selectively disrupt cell division.

 

Study Details

In a preclinical setting, TTFields applied to mesothelioma cell lines in vitro showed a significant reduction in the number of cells (69%, P < 0.001) and in clonogenicity (78%, P < 0.05) compared with control cells without application of TTFields. Combined treatment of TTFields with paclitaxel and cisplatin shows a synergistic effect.

The efficacy of TTFields in combination with chemotherapy in malignant pleural mesothelioma is currently being studied in an ongoing phase II clinical trial, STELLAR (NCT02397928).This is a prospective, nonrandomized, open-label study designed to test the safety and efficacy of TTFields (150 kHz) concomitant with pemetrexed and cisplatin or carboplatin in malignant mesothelioma. The study enrolled 80 patients in a single interventional arm and patients are still undergoing follow-up. Primary outcome is overall survival (OS). Secondary outcomes include progression-free survival (PFS), relative risk (RR), and toxicity.

Interim results from the first 42 patients included in the trial demonstrated a 12-month survival rate of 79.7% (95% CI, 57.2–91.2) and median PFS of 7.3 months (95% CI, 5.6–NA). Median survival has not been reached at that time. No device-related SAEs have been reported. Expected TTFields-related dermatitis was reported in 55% (23 patients). Only two patients had grade 3 dermatitis.

Novocure is an international oncology company with more than 450 employees and operations in Asia, Europe and the U.S. Mesothelioma will be the first cancer of its kind for which Novocure has applied for FDA approval.

If you have been diagnosed with mesothelioma, new treatment modalities such as TTFields could be effective in treating your specific type of mesothelioma. Talk to your doctor about the latest mesothelioma treatments today.

 

Sources

Mun, Elijah J., Hani M. Babiker, Uri Weinberg, Eilon D. Kirson, and Daniel D. Von Hoff. "Tumor-Treating Fields: A Fourth Modality in Cancer Treatment." AACR Journals. American Association for Cancer Research (AACR), Jan. 2018. Web. 12 June 2018.