• In the intent-to-treat population, patients treated with TTFields plus temozolomide showed a statistically significant increase in PFS, the primary endpoint, compared to temozolomide alone (median PFS 7.1 months versus 4.0 months, hazard ratio=0.62, p=0.0013).
• In the per-protocol population, patients treated with TTFields plus temozolomide demonstrated a statistically significant increase in OS, a powered secondary endpoint, compared to temozolomide alone (median OS 20.5 months versus 15.6 months, hazard ratio=0.64, p=0.0042). In the intent-to-treat population, the median OS was 19.6 months versus 16.6 months, respectively, hazard ratio=0.74 (p=0.0329). • The two-year survival rate was 50 percent greater with TTFields plus temozolomide versus temozolomide alone: 43 percent versus 29 percent.

In addition, the trial showed Optune could be safely combined with temozolomide. There was no significant increase in systemic toxicities from Optune in combination with temozolomide versus temozolomide alone. The most common adverse reaction from Optune treatment was mild to moderate skin irritation, which was easily managed, reversible and did not result in treatment discontinuation.
Read the full article published in the latest issue of JAMA.

“We are pleased the EF-14 trial results have been published in JAMA, one of the most highly recognized and respected peer-reviewed medical journals,” said Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “We believe the data will give physicians even greater confidence in the value and importance of Optune as an effective and safe treatment option for newly diagnosed GBM patients. We believe EF-14 is the first trial in glioblastoma to be stopped at the interim analysis because of clear superiority. The findings inspire us at Novocure to continue our robust research program investigating TTFields therapy in more than a dozen other solid tumor types.”

GBM is the most common and aggressive form of primary brain cancer. Approximately 12,500 people are diagnosed with GBM or tumors that typically progress to GBM in the United States each year. Median overall survival in newly diagnosed patients is approximately 15 months with existing standard therapies.

About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.

More HCB News