Long-Term Analysis of All 695 Patients Enrolled in Novocure’s Phase 3 Pivotal Trial in Newly Diagnosed Glioblastoma Confirms Successful Interim Analysis Results and Demonstrates Superior Two- and Four-Year Survival RatesBUSINESS WIRE 4:00 AM ET 11/18/2016
QUOTES AS OF 10:48:27 AM ET 11/18/2016
Patients treated with Optune® together with temozolomide demonstrated a significant increase in progression free and overall survival compared to patients treated with temozolomide alone
EF-14 patients treated with Optune together with temozolomide experienced a 70 percent improvement in survival rate at four years compared to patients treated with temozolomide alone
ST. HELIER, Jersey–(BUSINESS WIRE)– Novocure(NVCR) announced today that a long-term analysis of the full trial cohort from its phase 3 pivotal EF-14 trial of Optune® in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) confirmed the superior survival results seen at interim analysis. The long-term analysis demonstrated superior two-, three- and four-year survival of patients treated with Optune together with temozolomide compared to temozolomide alone. The interim analysis results – published in the Journal of the American Medical Association (JAMA) 1 in December 2015 – showed significant extension of both progression free and overall survival in newly diagnosed GBM patients receiving Optune with temozolomide compared to temozolomide alone.
EF-14 Principal Investigator Roger Stupp, M.D., Professor at the University of Zurich and Director of Department of Oncology at the Zurich University Hospital, Zurich, Switzerland, will present these late breaking results at the 21st Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) on Nov. 18, in Scottsdale, Arizona.
“The analysis of the full dataset confirms the improvement in both progression free and overall survival we saw in the trial’s interim analysis, and demonstrates superior long-term survival,” Dr. Stupp said. “These mature results further validate Optune as a standard of care treatment option for glioblastoma, providing patients with a therapy that can extend their survival while maintaining their quality of life.”
“We are excited that Novocure’s long-term analysis of the EF-14 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.”
The long-term analysis of all patients (n=695) shows that:
· Patients treated with Optune together with temozolomide demonstrated a significant increase in median progression free survival (PFS) compared to temozolomide alone (median PFS of 6.7 months versus 4.0 months, respectively, hazard ratio=0.63, p=0.00005).
· Patients treated with Optune together with temozolomide demonstrated a significant increase in median overall survival (OS) compared to temozolomide alone (median OS from randomization of 20.8 months versus 16.0 months, respectively, hazard ratio=0.65, p=0.0006)
· The percentage of patients alive at two years in the Optune 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 Optune 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.
· Consistent with the interim analysis, the OS and PFS benefit of Optune together with temozolomide compared to temozolomide alone was seen across all patient subgroups tracked in the EF-14 trial, 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.
“The long-term analysis further supports our data showing that Optune together with temozolomide is a better treatment option for newly diagnosed GBM patients compared to temozolomide alone,” said Asaf Danziger, Novocure’s CEO. “We believe these results will give health care providers further confidence in our therapy and transform the standard of care in newly diagnosed GBM. Our priority is to improve the lives of GBM patients, and we believe these results will help us to accomplish our mission.”