Novocure has enrolled its last patient in the STELLAR trial (NCT02397928) to assess the safety and effectiveness of Tumor Treating Fields (TTFields) in combination with standard chemotherapy in newly diagnosed, unresectable mesothelioma patients, the oncology pharmaceutical firm announced.
TTFields are low-intensity alternating electric fields that promote cancer cell death by preventing cells from multiplying. This non-invasive treatment method applies transducer arrays directly to the skin’s surface in the region surrounding the tumor. The delivery system is portable and lets patients go about their normal daily activities.
The Phase 2 STELLAR trial enrolled 80 patients to investigate the effects of receiving TTFields in the lungs specifically at 150 KHz — the optimal frequency for impairing cell division in mesothelioma, according to previous preclinical studies. Patients received TTFields in combination with either Alimta (pemetrexed) or Platinol (cisplatin) plus Paraplatin (carboplatin).
The study’s primary endpoint was a change in overall survival, but researchers also measured other parameters such as response rates, progression-free survival (PFS) and treatment-related adverse events.
Preliminary results, presented last year at the International Association for the Study of Lung Cancer (IASLC) 17th World Conference on Lung Cancer, showed that patients treated with a combination treatment of TTFields and chemotherapy had a one-year survival rate of 79.7 percent and a median PFS of 7.3 months.
This compared favorably to data from prior studies, which reported a 50.3 percent one-year survival rate and median PFS of 5.7 months in patients treated with Platinol plus Alimta alone.
Novocure, based in the British isle of Jersey, was founded in 2000 by Yoram Palti — a leading expert in biophysics and electrophysiology — in the basement of his home in Haifa, Israel.
“The interim data presented at the IASLC 17th World Conference on Lung Cancer were extremely encouraging in a disease where a significant unmet need clearly remains,” Uri Weinberg, Novocure’s vice-president of research and development, said in a news release. “The one-year survival rates of patients treated with TTFields combined with pemetrexed and cisplatin or carboplatin were more than 50 percent greater than historical control data.”
Added Novocure CEO Asaf Danziger: “We look forward to seeing the final results from the STELLAR trial. The interim data give us hope that TTFields used in combination with standard of care chemotherapies may increase survival for patients with mesothelioma without significantly increasing side effects.”
Treatment with TTFields is not approved for mesothelioma, nor has the safety and effectiveness of treatment with TTFields for mesothelioma been established.