Combining Tumor Treating Fields (TTFields), a method that uses electric fields to disrupt cell division, with standard chemotherapy treatments Alimta (pemetrexed) and Platinol (cisplatin) or Paraplatin (carboplatin) may be a promising treatment approach for mesothelioma patients, according to interim data from the STELLAR Phase 2 trial.
The findings will be presented at the International Association for the Study of Lung Cancer (IASLC) 17th World Conference on Lung Cancer Dec. 4-7 in Vienna.
The oral presentation is titled “Interim Results of a Phase 2 Trial of TTFields with Chemotherapy for First Line Treatment of Malignant Mesothelioma,” and suggests that TTFields is safe and markedly prolongs patient survival rates.
Novocure‘s TTFields are low-intensity alternating electric fields that activate programmed cell death in proliferating cancer cells by preventing them from dividing properly. It is a noninvasive treatment approach that applies transducer arrays directly to the skin’s surface in the region surrounding the tumor. The delivery system is portable and allows patients to perform their normal daily activities.
The STELLAR trial (NCT02397928) is designed to assess the safety and effectiveness of TTFields in combination with standard chemotherapy (Alimta plus Platinol, or Alimta plus Paraplatin) as a first-line therapy for 80 patients with unresectable mesothelioma.
Patients are set up to receive TTFields in the lungs at the specific frequency of 150 KHz, the optimal frequency for impairing cell division in mesothelioma, according to previous preclinical studies.
The study’s primary endpoint is overall survival and secondary endpoints include response rates, progression-free survival (PFS), and treatment-related adverse events.
Interim data from the first 42 enrolled patients, followed for an average of 11.5 months, has revealed a one-year survival rate of 79.7 percent and a median PFS of 7.3 months.
This contrasts with the 50.3 percent one-year survival rate and median PFS of 5.7 months seen in historical controls treated with Platinol plus Alimta alone, who were part of an older Phase 3 trial studying the safety and effectiveness of Platinol plus Alimta compared to Platinol alone.
Median survival had not been reached in the STELLAR trial at the time of analysis. In addition, none of the enrolled patients had experienced device-related serious adverse events.
“The interim STELLAR results are very encouraging,” Dr. Eilon Kirson, Novocure’s chief science officer and head of research and development, said in a press release. “We are pleased that the first clinical results in mesothelioma will be presented at IASLC and look forward to sharing additional data in pancreatic and ovarian cancer at our R&D day in December.”