Innovative Tumor-Fighting Tool Could Be Available to Mesothelioma Patients in 2019
A new tumor-fighting tool could be available to malignant pleural mesothelioma (MPM) patients as early as 2019. Thanks to the success of an ongoing multicenter phase II clinical trial evaluating the effectiveness of the novel treatment known as Tumor-Treating Fields (TTFields), the manufacturer has accelerated the FDA approval application process for the treatment of MPM. The company expects to receive a Humanitarian Device Exception (HDE) that could mark the beginning of distribution in the U.S.
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 ongoing multicenter phase II clinical trial, conducted by a team of researchers in Europe, has shown that TTFields as a first-line treatment improves the effectiveness of standard chemotherapy for MPM patients. TTFields works with chemotherapy to discerningly disrupt cell division.
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.
TTFields is manufactured by Novocure, an international oncology company with more than 450 employees and operations in the U.S., Europe and Asia. Mesothelioma will be the first cancer of its kind for which the company has applied for FDA approval.
If you have been diagnosed with mesothelioma, talk to your doctor about groundbreaking treatments such as TTFields. Innovative treatment modalities such as this could be effective in managing your specific type of mesothelioma. Talk to your doctor today.
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.