Combination of Optune® with Temozolomide Demonstrates Unprecedented Five-Year Survival for Newly Diagnosed Glioblastoma Patients
- September 29, 2017
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Newly diagnosed glioblastoma patients treated with Optune plus temozolomide were able to maintain quality of life for longer compared to those treated with temozolomide alone
Data presented today as a late-breaking oral presentation at the American Society for Radiation Oncology’s 2017 Annual Meeting
- HELIER, Jersey–(BUSINESS WIRE)– Novocure (NASDAQ: NVCR) announced today results from its phase 3 pivotal EF-14 trial adding Optune to temozolomide for the treatment of newly diagnosed glioblastoma (GBM), including results from health-related quality of life analyses, were presented at the American Society for Radiation Oncology’s (ASTRO) 2017 Annual Meeting in San Diego. This marks the first presentation of EF-14 five-year survival and quality of life data at a radiation oncology conference.
A late-breaking oral presentation focused on Novocure’s EF-14 phase 3 pivotal trial, which 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 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.
“As the first treatment in more than 10 years to improve overall survival in newly diagnosed GBM, Optune has been proven to make a difference in the lives of GBM patients,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. “It is great to have Optune as a topic of discussion in radiation oncology.”
The EF-14 data showed median overall survival was extended by nearly five months for patients who received Optune in combination with temozolomide versus patients who received temozolomide alone. When measured annually for five consecutive years, patients treated with Optune in combination with temozolomide maintained superior rates of survival in newly diagnosed GBM versus patients treated with temozolomide alone. The five-year survival rate was 13 percent for patients treated with Optune together with temozolomide versus five percent for patients treated with temozolomide alone.
The EF-14 data also showed that Optune with temozolomide did not negatively impact health-related quality of life, except for itchy skin. The combination treatment of Optune with temozolomide improved deterioration-free survival of several predefined health-related quality of life scales, compared to treatment with temozolomide alone.
Patients were asked to complete two validated health-related quality of life questionnaires (EORTC QLQ-C30 and BN20) at the beginning of the trial and every three months thereafter for as long as they were participating in the study. Health-related quality of life over time was assessed for nine preselected scales: global health, physical, cognitive, role, social and emotional functioning, itchy skin, pain and weakness of legs. The results were as follows:
- More patients treated with the combination of Optune and temozolomide reported stable or improved scores on: global health status (53 percent versus 38 percent, p=.001), pain (57 percent versus 36 percent, p<.0001), physical functioning (54 percent versus 38 percent, p=.001) and leg weakness (59 percent versus 42 percent, p=.001) when compared to patients treated with temozolomide alone.
- Deterioration-free survival (the time until quality of life declined by more than 10 points or disease progression) was longer (p<.01) for patients treated with the combination of Optune and temozolomide versus patients treated with temozolomide alone for: global health (4.8 versus 3.3 months), physical (5.1 versus 3.7 months) and emotional functioning (5.3 versus 3.9 months), pain (5.6 versus 3.6 months) and leg weakness (5.6 versus 3.9 months).
- Time to deterioration (the time until quality of life declined by more than 10 points, excluding disease progression) did not significantly differ between treatment arms, except for itchy skin (8.2 months for patients treated with Optune plus temozolomide versus 14.4 months for patients treated with temozolomide alone, p<.001), and pain (13.4 months for patients treated with Optune plus temozolomide versus 12.1 months for patients treated with temozolomide alone, p<.001).
- Health-related quality of life over time did not significantly differ between treatment arms except for itchy skin, which was worse with Optune plus temozolomide versus temozolomide alone, at three, six and nine months (p=.0004).