Novocure, a company that creates medical devices to treat cancer, announced this weekend that their Novo-TTF-100A system (now being called Optune), in combination with temozolomide (also know as Temodar or TMZ), demonstrated improved survival in newly diagnosed glioblastoma multiforme (GBM) patients in a clinical trial, compared with temozolomide alone. The announcement was made at the 2014 Society for Neuro-Oncology (SNO) Annual Meeting.
The study was a large Phase 3 clinical trial conducted across many medical centers in the U.S., as well as Europe, South Korea, and Israel. The trial enrolled approximately 700 patients, and data presented at SNO represented a scheduled interim analysis of 315 patients.
Patients who received both Optune and temozolomide, on average, survived 19.6 months, compared with an average survival of 16.6 months for those who only received temozolomide. Additionally, the trial showed patients using Optune had an increase in “progression free survival” of three months over patients who didn’t receive Optune (7.1 months vs. 4.0 months). Finally, the percentage of glioblastoma patients surviving at least two years was greater in the Optune and temozolomide arm (43%) than in the temozolomide alone arm (29%). No major added toxicities or adverse effects to patients were observed in the Optune/temozolomide arm.
Temozolomide is the current standard of care chemotherapy for glioblastoma patients. Full standard of care currently for newly diagnosed glioblastoma patients is surgery followed by radiation therapy along with temozolomide. Patients in this study first received surgery, then concurrent radiation and temozolomide treatment, before being enrolled and randomly assigned into the trial’s arms.
The data from this interim analysis were significant enough for an independent review committee to recommend that Novocure can end their trial early and move toward U.S. Food and Drug Administration approval in newly diagnosed glioblastoma patients.
National Brain Tumor Society is encouraged by these results, as increases in overall survival and progression free survival have been difficult to achieve in the glioblastoma patient population, due to the complex and aggressive nature of the tumor. With these results, a novel treatment option for newly diagnosed patients may have emerged.
National Brain Tumor Society is following this development very closely and discussing the implications with leaders in the field. We look forward to learning more about the next steps in this process and communicating those with the community when available.
In the meantime, Optune looks to be a treatment option that glioblastoma patients should ask their medical team about, so as to consider all of the potential treatment options available.
Stay tuned for more soon…
- Optune was previously approved by the FDA to treat recurrent glioblastoma patients, making it already available through a number of medical centers.
- Optune is meant to be worn continuously by patients.
- Researchers did note that patients receiving Optune experienced increased anxiety in the early stages of treatment.