Novocure received a long-sought FDA approval for the use of its Tumor Treating Fields technology against metastatic non-small cell lung cancer—which the company described as the first treatment of its kind for the aggressive disease.
Its portable Optune Lua device, with arrays on adhesive patches worn on the chest or back, received a green light for patients that are also being treated with PD-1/PD-L1 inhibitors or the chemotherapy docetaxel, and who have seen their cancer progress after receiving a platinum-based treatment regimen.
With stimulators previously approved as a treatment for the brain tumor glioblastoma multiforme, as well as malignant pleural mesothelioma, Novocure’s electric field-based therapies aim to physically interfere with the charged components of cancer cells as they divide, reproduce and spread, helping the immune system to respond to the tumor.
In 2023, Novocure presented clinical data from a pivotal, phase 3 trial that showed adding Tumor Treating Fields led to significant gains in overall survival versus standard therapies, reaching a median of 13.2 months compared to 9.9 months, respectively. The results, which the company said were the first gains seen in metastatic NSCLC in years, were published last year in The Lancet Oncology.
“The overall survival results we observed with Optune Lua in the LUNAR study mark the first substantial improvement in more than eight years in this patient population which, when combined with Optune Lua’s lack of systemic toxicity, make this a compelling development for many patients and their physicians who need better treatment options for this advanced disease,” said the study’s primary investigator, Ticiana Leal, director of thoracic oncology at Emory’s Winship Cancer Institute.
The majority of device-related side effects were related to low-grade skin disorders under the adhesive pads; 4% of treated patients saw skin issues that needed a break from therapy, according to the company.
Novocure submitted Optune Lua for FDA review in NSCLC in December 2023, after also seeking a CE Mark approval in Europe. Around the same time—and following the field’s failure in a phase 3 ovarian cancer trial a few months before—the company aimed to reduce its operating expenses by about $60 million, resulting in layoffs that affected about 200 employees or about 13% of its workforce.
Early 2023 also saw a shuffling of its executive team, including the departure of its chief medical officer and the creation of a new position: chief growth officer.
More recently, in September of this year, Novocure announced that CEO Asaf Danziger would be stepping down from the post at the end of this year, after serving as chief since 2002. He will be succeeded by the company’s chief financial officer, Ashley Cordova.
In addition, Chief Operating Officer Wilco Groenhuysen will depart after 12 years in the job, with Mukund Paravasthu, senior VP of product development, moving into the slot. Danziger, meanwhile, plans to stay on as a senior advisor through early 2026 and will maintain his seat on Novocure’s board.
“It has been a special honor and one of the greatest privileges of my life to serve as Novocure’s CEO for the last 22 years,” Danziger said in a statement. “I am very proud of the organization we have built starting with just a few people in a preclinical lab to where we stand today—treating thousands of patients living with aggressive forms of cancer. Now, we are poised to expand the potential of Tumor Treating Fields therapy to many more people. I am confident that under Ashley’s leadership Novocure is well-positioned to achieve great things.”
Elsewhere in its pipeline, the company is studying Tumor Treating Fields in brain metastases and pancreatic cancer, as well as in other immunotherapy and chemotherapy combinations for lung cancer.