Shares in Novocure (NSDQ:NVCR) jumped nearly 50% today after the company touted 5-year data today from the Phase III pivotal EF-14 trial evaluating its Optune device with temozolomide chemotherapy as a treatment for newly-diagnosed glioblastoma.
Data from 695 patients showed a consistent and maintained improvement in overall survival at 2, 3, 4 and 5 years, the Jersey, U.K.-based company said. Novocure’s Optune mobile device delivers low-intensity, intermediate frequency, alternating electric fields, called “tumor treating fields” or TTFields, to inhibit cancer cell replication.
For patients treated with Optune and temozolomide, the 2-year survival rate increased from 30% to 40% compared to those who were treated with just chemotherapy. The 5-year survival rate grew from 5% to 13% for patients treated with the combination therapy. Novocure said that these results are the best ever reported for patients with newly-diagnosed GBM in a Phase III trial.
“When I started treating patients with GBM 20 years ago, the majority of patients died within less than 1 year and long-term survival was nearly absent. Now, we see a meaningful improvement in survival at two years and beyond,” principal investigator Dr. Roger Stupp said in prepared remarks. “With the combination of Optune and temozolomide, 1 out of 7 patients is living longer than 5 years.”
“This is the 1st positive Phase III trial in newly diagnosed GBM since we demonstrated the efficacy of temozolomide in 2005, establishing it as a standard 1st-line therapy,” Stupp added. “Beyond GBM, I believe this trial establishes an entirely different approach to cancer treatment with minimal toxicity which may be well suited for combination with conventional treatments for many other cancer types.”
Combining Optune with chemotherapy extended the median overall survival of newly-diagnosed GBM patients to 21 months.
“We are excited that combination therapy with Optune plus temozolomide continues to show a meaningful extension of long-term survival for newly diagnosed GBM patients,” the American Brain Tumor Association’s president & CEO Elizabeth Wilson said. “Before temozolomide was approved, newly diagnosed GBM patients only had a 1.9% 5-year survival rate, so to see numbers that are over 6 times that rate shows the significant progress that has been made in treating this disease.”
The combination treatment had a safety profile that was consistent with previous data from the study, Novocure said.
“These data further support our belief that Optune plus temozolomide is an essential combination treatment for patients with newly diagnosed GBM,” CEO Asaf Danziger said. “The efficacy shown in EF-14 for GBM gives us hope that TTFields used in combination other cancer treatments may increase survival without significantly increasing side effects for a variety of solid tumors.”
NVCR shares were trading at $11.88 apiece in mid-morning activity today, up 47%.