Tumor treatment electric field significantly prolongs the overall survival of patients, and is expected to treat a variety of cancers
April 20, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];NovoCure has announced that its second phase clinical trial, STELLAR, has achieved positive top-line results, including Tumor Treating Fields plus standard chemotherapy, including pemetrexed and cisplatin or carboplatin. The overall survival (OS) and progression-free survival (PFS) of mesothelioma patients have clinically significant prolongation.
Malignant mesothelioma is a rare solid tumor of the chest that is closely related to asbestos exposure. It has a long incubation period of at least 20-30 years after exposure to asbestos. There are approximately 3,000 new cases of mesothelioma in the United States each year. The prognosis of these patients is very poor, and in most of the reported studies, the median overall survival was about 12 months.
NovoCure, a global oncology company, developed a proprietary platform technology called the Tumor Therapy Electric Field, which uses electric fields tuned to specific frequencies to disrupt solid tumor cell division. NovoCure's commercial products have been approved for the treatment of adult glioblastoma patients. NovoCure is conducting a number of clinical trials using tumor-treated electric fields to treat brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma.
â–²Novocure Executive Chairman Bill Doyle at the 2018 WuXi PharmaTech Global Forum
The STELLAR trial is a phase 2 trial single, open-label, multicenter trial. In a study of 80 patients with unresectable, untreated malignant pleural mesothelioma, the efficacy and safety of a combination of tumor treatment electric field with standard chemotherapy, pemetrexed plus cisplatin or carboplatin was tested. A historical comparison of this trial was the result of the 2003 Pemetrexed FDA Registry Phase 3 trial. The final data for this study exceeded the mid-term analysis of all efficacy endpoints submitted at the 17th World Lung Cancer Congress of the International Association for the Study of Lung Cancer (IASLC) in December 2016. No serious adverse events related to the device were found. NovoCure will present complete research data at the upcoming medical conference.
In the interim analysis of the first 42 patients in December 2016, the mean follow-up time was 11.5 months. The one-year survival rate of patients treated with tumor-treated electric fields in combination with pemetrexed and cisplatin or carboplatin was 80%, compared with 50% in the historical control group using pemetrexed and cisplatin alone. The median progression-free survival of the tumor-treated electric field treatment group was 7.3 months, and the historical control was 5.7 months.
â–² Dr. Eilon Kirson, Chief Scientific Officer and Head of Research and Development at NovoCure (Source: NovoCure Official Website)
“We are very pleased with these top-line results, which brings us closer to the urgent need for new treatments for mesothelioma patients,†said Dr. Eilon Kirson, Chief Scientific Officer and Head of Research and Development at NovoCure. “Mesothelioma is Novocure seeking FDA approval. The first torso indication. STELLAR data makes us more convinced that the tumor treatment electric field may be a platform technology for a wide range of solid tumor treatments. We look forward to sharing the detailed results of the study with the lung cancer community at the upcoming medical conference."
NovoCure's oncology treatment field has previously been approved by Humanitarian Use Equipment (HUD) for the treatment of pleural mesothelioma. Based on the final STELLAR data, NovoCure plans to apply for a Humanitarian Equipment Exemption (HDE) from the FDA. If HDE is approved, it will allow NovoCure to combine the tumor treatment electric field with a standard chemotherapy regimen as a treatment for US pleural mesothelioma.
We expect this cancer treatment to provide new treatments for a variety of cancer patients, significantly extending the lives of patients.
Reference materials:
[1] Novocure Reports Positive Top-line Results from STELLAR Phase 2 Pilot Trial in Mesothelioma
[2] Novocure official website
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