Recurrent GBM

In recurrent GBM,

Approximately 20% of patients in each EF-11 treatment arm had failed a prior bevacizumab-containing regimen²⁸

Key efficacy endpoints^1,28

• Primary endpoint
  • OS
• Secondary endpoints
  • PFS
  • 1-year survival
  • PFS6
  • Median time to progression
  • Radiological response rates
  • QoL

Key Inclusion Criteria^{1, 28}

• Not a candidate for further radiotherapy or additional resection of residual tumor

Key inclusion criteria^1,3

• Underwent maximal debulking surgery and radiotherapy concomitant with TMZ
• KPS ≥70

Key exclusion criteria¹

• Progressive disease per Macdonald criteria, following concomitant chemoradiation
• Implanted electronic medical devices
• Significant comorbidities at baseline that would prevent maintenance TMZ treatment
• Infratentorial tumor(s)

In recurrent GBM,

• OS was significantly higher in patients who received Optune Gio for ≥18 hours per day (n=92) vs those who received therapy for <18 hours per day (n=28), 7.7 months vs 4.5 months, respectively³¹
• Median usage was 86% (range 41%-98%) of the time in each treatment month, translating into a mean use of 20.6 hours per day²⁸

In recurrent GBM,

• No clinically meaningful differences were found in global health and social functioning²⁸
• Data collected by EORTC QLQ-C30 questionnaire²⁸

• Optune Gio monotherapy was associated with more favorable changes in patient-reported symptoms²⁸
• Data collected by EORTC QLQ-C30 questionnaire²⁸

• The most common (≥10%) AEs seen with Optune Gio monotherapy were medical device site reaction and headache³²
• The following AEs were considered related to Optune Gio: medical device site reaction, headache, malaise, muscle twitching, fall, and skin ulcer²⁸
• In EF-11, 16% of patients experienced a grade 1/2 medical device site reaction²⁸
• Mild-to-moderate skin irritation, the most common device-related side effect with Optune Gio, was typically manageable, reversible, and did not result in treatment discontinuation²⁸

• Significantly fewer of the systemic AEs associated with chemotherapy, including gastrointestinal side effects, hematological side effects, and infections, were observed with Optune Gio¹