Novocure (NSDQ:NVCR) today released results from the Stellar phase 2 registration trial exploring the use of its Tumor Treating Fields and standard of care chemotherapy to chemotherapy alone in treating mesothelioma, touting a significant extension in median overall survival.
Patients with malignant pleural mesothelioma who received TTF treatment alongside pemetrexed and cisplatin or carboplatin experienced a median overall survival of 18.2 months, compared to 12.1 months in a historical control, the St. Helier, Jersey-based company said.
Results also indicated that patients who received the combined therapy had a median progression free survival of 7.6 months compared to 5.7 months in the historical control, with partial responses seen in 40.3% of patients and clinical benefits of either partial response or stable disease in 97.2% of patients.
No serious device-related adverse events were reported, Novocure said, though skin irritation was reported in 46% of patients using TTF, with 5% reporting grade 3 skin irritation.
“The final results of the Stellar trial demonstrate an impressive extension of median overall survival in the treatment of malignant pleural mesothelioma with no increase in systemic toxicity. Mesothelioma patients face an urgent unmet need for additional therapies that improve survival. Based on these data, I believe Tumor Treating Fields represent an extremely promising therapeutic option that, if approved, should be added to standard of care chemotherapy for the treatment of malignant pleural mesothelioma,” Stellar trial investigator Dr. Giovanni Ceresoli of Bergamo, Italy’s Humanitas Gavazzeni Hospital said in a prepared statement.
“We are extremely pleased by the results of the Stellar trial. We believe the results support the use of Tumor Treating Fields in our first indication outside of the brain. We are now one step closer to commercializing Tumor Treating Fields as a treatment for malignant pleural mesothelioma,” Novocure chief science officer Dr. Eilon Kirson said in a press release.
Last month, NovoCure and US Oncology Research announced they are collaborating on a phase III pivotal trial designed to test Novocure’s Tumor Treating Fields with nab-paclitaxel and gemcitabine in patients with unresectable locally advanced pancreatic cancer.