Novocure (NVCR) Announces Strong Long-Term Data from Optune Combo Phase 3 in GBM

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November 18, 2016

A full analysis was on tumor treating fields (TTFields) was released today, based on a Phase 3 trial of newly diagnosed glioblastoma patients. According to the long-term data from the study, analysis of TTFields, also called Optune®, showed significant extension of progression free (PFS) and overall survival (OS) in newly diagnosed GBM patients who received TTF and temozolomide compared to temozolomide alone.

TTFields therapy is delivered by a portable, non-invasive medical device for continuous use by GBM patients. Previous 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.

“We are encouraged that Novocure’s long-term analysis of this trial confirms the interim analysis results of superior overall and progression free survival, while providing new data on potential long-term survival benefits for newly diagnosed GBM patients,” said Elizabeth M. Wilson, President and CEO of the American Brain Tumor Association. “GBM patients need better treatment options, and it is a great day when new evidence shows that we are making progress in treating this disease.”

In this phase 3 study of 695 newly diagnosed glioblastoma patients, Novocure, manufacturers of TTFields therapy, found significant survival results at two-, three- and four-year survival of patients treated with TTFields and temozolomide, compared with the current standard of care of taking temozolomide alone.

Additional results from this trial (EF-14) was presented today at the 21st Society of Neuro-Oncology Annual Meeting in Scottsdale, AZ, which demonstrates:

  • Patients treated with TTFields and temozolomide demonstrated a significant increase in median progression free survival (PFS) compared to temozolomide alone
  • Patients treated with TTFields together with temozolomide demonstrated a significant increase in median overall survival (OS) compared to temozolomide alone
  • The percentage of patients alive at two years in the TTFields together with temozolomide arm was 43 percent compared to 30 percent in the temozolomide alone arm, a 43% increase in the chance of living two years.
  • The percentage of patients alive at four years in the TTFields together with temozolomide arm was 17 percent compared to 10 percent in the temozolomide alone arm, a 70% increase in the chance of living four years.
  • This data was consistent with early data released in the Dec 2015 Journal of American Medical Association (JAMA) and was seen across all patient subgroups in the study, including patient age, performance status and tumor genetics.
  • The safety profile in the long-term analysis was consistent with the interim analysis of the EF-14 trial. 

GBM is the most common and aggressive primary brain cancer. An estimated 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 current standard of care.

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