Novocure has announced results from a retrospective post-hoc analysis of its phase 3 pivotal EF-14 trial data showing that increased compliance with Optune predicted increased survival in glioblastoma (GBM) patients.
Results were highlighted in an oral presentation at the 22nd Annual Meeting of the Society for Neuro-Oncology (SNO) in San Francisco.
The analysis showed that an Optune compliance threshold as low as 50 percent correlated with significantly improved outcomes in patients treated with Optune together with temozolomide compared to patients treated with temozolomide alone. The results also demonstrated that the greater patients’ compliance with Optune, the better their outcomes.
Patients who used Optune more than 90 percent of the time (n=43) had the greatest chance of survival: a median survival of 24.9 months from randomization and a five-year survival of 29.3 percent. The median time from diagnosis to randomization was 3.8 months for patients treated with Optune together with temozolomide.
“Increased compliance with Optune led to increased survival in GBM,” said Zvi Ram, MD, Director of Neurosurgery at the Tel-Aviv Sourasky Medical Center in Tel-Aviv, who presented the data at SNO.
“These data show that nearly one in three GBM patients in the EF-14 trial who were more than 90 percent compliant with Optune reached five-year survival. Compliance with Optune matters and changed the course of the disease for many GBM patients. I feel honored to share these insightful data.”
Novocure’s phase 3 pivotal EF-14 trial compared Optune in combination with temozolomide to temozolomide alone in 695 patients with newly diagnosed GBM. The trial was designed to test both progression free survival (PFS) and overall survival (OS).
The trial demonstrated unprecedented five-year survival results in newly diagnosed GBM. Patients treated with Optune in combination with temozolomide experienced a significant extension of overall survival without added systemic toxicity compared to patients treated with temozolomide alone.
The data also showed that Optune-treated patients were able to maintain quality of life for longer compared to patients treated with temozolomide alone.
Patients in the EF-14 trial treated with Optune together with temozolomide were recommended to use Optune 75 percent of the time, or 18 hours per day. This new analysis demonstrated that a threshold value as low as 50 percent compliance with Optune led to an extension of both PFS (n= 62, HR 0.70, 95 percent CI 0.47–1.05) and OS (n= 62, HR 0.67, 95 percent CI 0.45–0.99) versus temozolomide alone. As compliance increased to 75 percent or greater, the survival benefit significantly increased (p=0.031). Patients who used Optune 70-80 percent of the time had a median survival of 21.7 months (n= 91).
Patients who used Optune more than 90 percent of the time had the greatest chance of survival: a median survival of 24.9 months from randomization and a five-year survival of 29.3 percent (>90 percent compliance: n= 43, PFS HR 0.54, 95 percent CI 0.37–0.79; OS HR 0.52, 95 percent CI 0.35–0.79). The median time from diagnosis to randomization was 3.8 months for patients treated with Optune together with temozolomide. The data also show that increased compliance independently predicted survival and was not affected by prognostic factors such as performance status, age or MGMT methylation.
“We are pleased with this latest analysis showing that GBM patients who were the most compliant with Optune had the greatest chance of five-year survival,” said Novocure CEO Asaf Danziger. “We are committed to further exploring our EF-14 data with the hopes of improving treatment outcomes in GBM.”
Novocure is an oncology company developing a profoundly different cancer treatment utilizing a proprietary therapy called Tumor Treating Fields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division.
Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma.
Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel.
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
For the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.